Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
Research Study Protocol
CHIEF INVESTIGATOR| Dr Shannon Nott | Western NSW Local Health District
HOST ORGANISATION | Western NSW Local Health District
COLLABORATORS | Far West NSW Local Health District, Clinical Excellence Commission, Agency for Clinical Innovation, Hunter Medical Research Institute, Central Queensland University, University of Sydney
Translational Research Grants Scheme
Proudly funded by
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1 TABLE OF CONTENTS
1 TABLE OF CONTENTS ...... 2 2 STUDY PROTOCOL HISTORY ...... 5 2.1 Study Title ...... 5 2.2 Version ...... 5 2.3 Amendments ...... 5 3 INTRODUCTION ...... 6 4 RATIONALE AND RESEARCH BACKGROUND ...... 6 5 WHAT IS VIRTUAL CLINICAL PHARMACY? ...... 7 5.1 Summary ...... 7 5.2 Patient referral and prioritisation ...... 8 5.3 Medication Reconciliation ...... 10 5.4 Patient education ...... 10 5.5 Staff education ...... 11 5.6 Medication Review ...... 11 5.7 Documentation and intervention recording ...... 11 5.8 Communication, engagement and change management...... 12 6 RESEARCH TEAM, GOVERNANCE AND FUNDING ...... 12 6.1 Investigators ...... 12 6.2 Research Governance and Partners ...... 13 6.3 Funding ...... 13 7 PROJECT DURATION AND TIME LINE ...... 13 8 AIMS OF PROJECT ...... 14 9 RESEARCH QUESTIONS ...... 14 10 PROJECT SETTINGS AND LOCATIONS ...... 14 10.1 Site eligibility and selection ...... 14 10.2 Study sites ...... 15 10.3 Control sites ...... 16 11 VIRTUAL PHARMACY ...... 16 11.1 Duration ...... 16 11.2 Research design and methodology ...... 16 11.3 Process and outcome measures ...... 17 11.4 13. 4...... Error! Bookmark not defined. 11.4.1 Inclusion criteria ...... 17 11.4.2 Exclusion criteria ...... 17 11.5 Potential for risk, burden and benefits ...... 18 11.5.1 Risks...... 18 11.5.2 Burdens ...... 18 11.5.3 Benefits ...... 18 11.6 Consent ...... 18 11.7 Data management ...... 19
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11.8 Sample size and data analysis ...... 19 11.8.1 Quantitative analysis ...... 19 11.8.2 Economic analysis ...... 20 12 PATIENT REPORTED EXPERIENCE MEASURES ...... 20 12.1 Duration ...... 20 12.2 Research design and methodology ...... 20 12.3 Process and outcome measures ...... 21 12.4 Patient Population ...... 21 12.4.1 Inclusion criteria ...... 21 12.4.2 Exclusion criteria ...... 21 12.5 Potential for risk, burden and benefits ...... 21 12.5.1 Risks...... 21 12.5.2 Burdens ...... 22 12.5.3 Benefits ...... 22 12.6 Consent ...... 22 12.7 Data management ...... 22 12.8 Sample size and data analysis ...... 23 13 PATIENT MEDICATION ADHERENCE QUESTIONNAIRE (MMAS-8) ...... 23 13.1 Duration ...... 23 13.2 Research design and methodology ...... 23 13.3 Process and outcome measures ...... 23 13.4 Patient Population ...... 24 13.4.1 Inclusion criteria ...... 24 13.4.2 Exclusion criteria ...... 24 13.5 Potential for risk, burden and benefits ...... 24 13.5.1 Risks...... 24 13.5.2 Burdens ...... 24 13.5.3 Benefits ...... 24 13.6 Consent ...... 24 13.7 Data management ...... 25 13.8 Sample size and data analysis ...... 25 14 STAFF FOCUS GROUPS ...... 25 14.1 Duration ...... 25 14.2 Research design and methodology ...... 25 14.3 Process and outcome measures ...... 26 14.4 Participant Population ...... 26 14.4.1 Inclusion criteria ...... 26 14.4.2 Exclusion criteria ...... 26 14.5 Potential for risk, burden and benefits ...... 26 14.5.1 Risks...... 26 14.5.2 Burdens ...... 26 14.5.3 Benefits ...... 27 14.6 Consent ...... 27 14.7 Data management ...... 27 14.8 Sample size and data analysis ...... 27 15 PROJECT OUTCOMES ...... 27 16 OUTCOMES AND SIGNIFICANCE ...... 28 3 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
16.1 Providing world-class health care closer to home ...... 28 16.2 Tangible benefits to patients ...... 29 16.3 Smaller facilities having equitable access to pharmacy services to meet accreditation ...... 29 16.4 Effectiveness and potential scalability of the VCPS ...... 29 17 ETHICAL APPROVAL ...... 29 18 DISSEMINATION OF RESULTS AND PUBLICATIONS ...... 29 19 REFERENCES ...... 29 20 APPENDICES ...... 32 20.1 Glossary of abbreviations...... 32 20.2 Patient reported experience measures survey ...... 33 20.2.1 PREMS survey invitation ...... 33 20.2.2 PREMS survey questions ...... 33 20.3 Patient Medication Adherence Questionnaire (MMAS-8)...... 34 20.3.1 MMAS-8 survey invitation script ...... 34 20.3.2 MMAS-8 Questions ...... 34 20.4 Focus group questions ...... 35 20.5 Staff focus group information sheet and consent form ...... 36 20.6 Aboriginal health impact statement ...... 39 20.7 Essential research partners ...... 47 20.8 NSQHS Medication Safety Standard 4 ...... 50 20.9 MMAS-8 and PREMS VCPS Patient information sheet ...... 53 20.10 PREMS face to face pharmacy (control group) patient information sheet ...... 55
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2 STUDY PROTOCOL HISTORY 2.1 Study Title Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
2.2 Version Version 2.0 updated 22 November 2019
2.3 Amendments Version Date Author Comments
1.0 23/10/2019 Brett First draft Chambers
1.1 25/10/2019 Chris Update 14.1.1 quantitative analysis, 14.1.4 economic analysis, Oldmeadow, 13.1.3-4 survey consent Chris Doran
1.2 5/11/2019 Brett Update figure 2 to include transfer or discharge, updated table Chambers, 1 to include Aboriginal measures (28 day readmission, length of Clare stay). Coleman
2.0 19/11/2019 Brett Major revision to incorporate GWHREC feedback. Reformatting Chambers of protocol into separate interventions. Addition of several sections such as duration and process and outcome measures. Update of 5.2 patient prioritisation, update 10.1 site selection procedures and 11.2 stepped wedge study design features including Figure 9.
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3 INTRODUCTION Globally, medication errors are a leading cause of avoidable morbidity and mortality with an estimated cost of $42 billion annually [33]. Medication-related incidents are the second most frequently reported incidents in NSW. Consequently, improved medication management is a high priority, particularly in rural and remote settings where access to clinical pharmacy services is poor. Western NSW Local Health District (WNSWLHD) and Far West LHD (FWLHD) comprise some of the most remote regions in NSW. Between them, they cover almost 450,000km2 with a population nearing 300,000 people. These rural LHDs serve their population through a combination of rural referral hospitals, rural hospitals, multipurpose facilities and nurse-only remote clinics.
Onsite clinical pharmacy services are provided to 7 of 38 facilities within WNSWLHD, resulting in suboptimal medication management, increased medication-related error risk and noncompliance with Standard 4 of the National Safety & Quality Health Service Standards (NSQHS) (see Appendix 20.8) [31]. Existing telehealth infrastructure along with recent roll out of electronic medication management (eMeds) in the electronic medical record (eMR), has provided the infrastructure for a virtual clinical pharmacy service (VCPS). WNSWLHD implemented an innovative pilot of a virtual pharmacy in four facilities from 2016 to 2018 indicating local feasibility. The pilot resulted in 237 referrals to the virtual pharmacist and 157 medication management plans.
4 RATIONALE AND RESEARCH BACKGROUND Medication reconciliation (Med Rec) is the process of ensuring that patients receive all intended medicines and that accurate, current and comprehensive medicines information follows them at all transfers of care. In the hospital setting, Med Rec is a crucial overarching strategy that has been reliably found to improve medication safety [1-6]. Med Rec has been flagged as an international priority by the World Health Organization [1, 7, 8]. It is well recognised that pharmacists are the most effective in performing Med Recs [8, 14, 19, 27]. Australian research indicates that between 60-80% of patients have a discrepancy with their medication history which increases the risk of readmission 2.3 fold [13]. There is currently sub-optimal provision of medication review and Med Rec in rural Australian health facilities due to the lack of on-site pharmacists [15-18]. A major review of all pharmacy services in WNSWLHD reinforced available evidence by highlighting a significant shortage of pharmacy service delivery across rural facilities that puts patients at a higher risk for medication- related harms [30]. Integrating clinical pharmacists into acute hospital settings improves medication management, reduces medication harm, supports patients in managing their medications, and decreases unwarranted clinical variation [22]. Current evidence indicates that telepharmacy has been implemented across parts of rural and remote Australia, particularly Queensland, however much of the literature is largely focussed on outpatient medication reviews (similar to Home Medication Reviews) as opposed to providing inpatient services [21-24]. A feasibility study evaluating a service developed to provide clinical pharmacy reviews for inpatients in rural and remote regions was found to be acceptable [23]. Despite this, few studies have since reviewed the efficacy of such a service, with most studies focussing on patient satisfaction [23]. The implementation and evaluation of a VCPS can add to the existing literature by formally assessing the efficacy of such a service, particularly within the context of the NSW Health environment. The use of virtual service delivery has been demonstrated to increase accessibility to specialist care particularly for rural and remote populations including Aboriginal communities, with extensive evidence supporting the use of virtual technologies for the management of chronic diseases [20]. The NSQHS has increased the focus on medication safety and the role of pharmacy in supporting best practice medication management. Both FWLHD and WNSWLHD experience challenges meeting accreditation, specifically Standard 4- medication safety [31]. A VCPS offers a solution to improve
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compliance with Standard 4 and more importantly improve the delivery of safe and high-quality healthcare regardless of geographical location.
5 WHAT IS VIRTUAL CLINICAL PHARMACY? 5.1 Summary The virtual clinical pharmacists will provide a telehealth service which is consistent with conventional face to face hospital pharmacy services. Depending on the patients’ medical history and reason for admission they may receive one or more of the pharmacy activities summarised below:
Patient prioritisation and recognition of high-risk patients Medication reconciliation particularly during transitions of care Patient education Staff education Health facility engagement Medication review and addressing polypharmacy Documentation and intervention recording Antimicrobial stewardship The virtual pharmacists will utilise the eMR, eMeds and a “Wallie” wireless teleconferencing cart with two–way audio and visual (located in all WNSWLHD and FWLHD health facilities) to provide clinical pharmacy services to study sites (see flow chart of activities in Fig. 1 below). The Pharmacists will work during business hours, Monday-Friday of each week over the study period where it is anticipated they will see approximately 5-10 patients per pharmacist per day depending on the complexity of patients’ medication regimens.
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Figure 1: Flow chart of the virtual clinical pharmacist activities 5.2 Patient referral and prioritisation It is not always possible to see all patients at facilities with face to face clinical pharmacy services and the same may occur with the VCPS. Patients who are at the highest risk of medication related harm will be prioritised for review. Prioritisation is based on the definition from the NSQHS Standard 4- medication safety (see Fig. 2 below) and the Society of Hospital Pharmacists of Australia (SHPA) Standards of Practice [6, 31].
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Figure 2: NSQHS definition of a patient at high risk of medication harm A referral to see a virtual pharmacist may be from a clinician at the trial site using the eMR pharmacy consult (see Fig. 3 below). The eMR consult contains a multi-select field called high risk patient so the referring clinician can add additional information for prioritisation. Referring staff should include if the patient has visual, hearing or cognitive impairment and if the patient consents to the pharmacist contacting their community pharmacy or GP for medication information.
Figure 3: eMR Pharmacy Consult Referral Tool Alternatively the pharmacist will self-refer patients based on medication chart review or by utilising the eMR Pharmacy Care Organiser summary page (see Fig. 4 below), which can assist in the identification of patients requiring pharmacy services.
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Figure 4: Pharmacy Care Organiser summary page 5.3 Medication Reconciliation Medication reconciliation (Med Rec) is a formal process intended to prevent medication errors and medication related problems at transition points in patient care [6]. Virtual clinical pharmacists will conduct Med Rec on admission, discharge or transfer and document the best possible medication history in eMeds. A summary of the Med Rec and any identified issues will be documented on the eMR Medication Management Plan PowerNote (see Fig. 5 below). Interventions will be raised for issues that require prescriber or nursing management. Interventions of immediate clinical concern will be followed up with direct communication between pharmacist and site doctor or nurse. To ensure continuity of medication management on discharge back to the community, the pharmacist will provide an updated medication list on discharge.
Figure 5: Sections of eMR Medication Management Plan PowerNote 5.4 Patient education Providing medication information to patients is a core element of patient centred care [6]. It engages patients with their healthcare, improves patient capacity for involvement and encourages safe and appropriate use of medications [6]. Where appropriate, the virtual clinical pharmacist will provide comprehensive information to the patient or carer to enable safe and effective use of the medications. This will be tailored to suit the patient’s individual circumstances and may be in the form of verbal instructions, demonstration, education, a medication list (see Fig. 6 below), written advice or a consumer medicines information sheet.
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Figure 6: An example of a patient medication list 5.5 Staff education Pharmacists provide medicines information to health professionals to influence the prescribing, administration, monitoring and use of medicines for individual patients [6]. The virtual clinical pharmacists may respond directly to a request for information from another health professional. This may be in the form of verbal instructions, demonstration, education, provision of specific drug protocols or product information and advice on medication availability and formulary restriction. 5.6 Medication Review Medication order review involves assessing all current and recent medication orders with the aim of optimising quality use of medicines, patient outcomes and minimise medication related problems [6]. The virtual clinical pharmacist will take into account patient specific factors and provide advice on the most appropriate dose, dosage form, timing and duration of therapy so that risk of medication related problems are minimised [6]. The virtual clinical pharmacist will do this by:
Reviewing all prescribed medication orders Optimising chronic disease therapy Identifying drug related causes of admission Detecting medication interactions Reviewing medications that may contribute to falls risk Optimising venous thromboembolism (VTE) prophylaxis Providing antimicrobial stewardship review Providing monitoring for narrow therapeutic drugs
5.7 Documentation and intervention recording The virtual clinical pharmacists will document identified actual and potential medication related problems, clinical decisions and suggested changes to medication therapy in the patient’s eMR. This will consist of the Clinical Intervention PowerForm (see Fig. 7 below) and the Mediation Management Plan PowerNote (See Fig. 5).
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Figure 7: eMR Clinical Intervention PowerForm 5.8 Communication, engagement and change management The virtual clinical pharmacists, project lead or other investigators will work on a coordinated communication, engage and change management process with study sites to ensure the new model of care in embedded into practice. This will involve providing education and training on the service with the aim of building rapport and ensure a successful implementation. This may involve activities such as site visits, telephone consults and videoconferencing.
6 RESEARCH TEAM, GOVERNANCE AND FUNDING 6.1 Investigators Position and Name Institution Responsibilities Contact Details CHIEF INVESITGATOR Clinical Lead, grant Rural Health Director of application, research Medical Services, design, project oversight
Dr Shannon Nott WNSWLHD and governance [email protected] ASSOCIATE INVESTIGATORS Project coordination and management, budgeting, Project Lead, preparation of
Brett Chambers WNSWLHD applications, governance [email protected] Research design, qualitative measures, data Acting Director of analysis and preparation of
Dr Julaine Allan Research, WNSWLHD publications [email protected] Research Professor, Health economic measures Professor Chris Central Queensland and economic evaluation
Doran University of the study [email protected]
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Research design. Assist Senior Statistician, ethics approval process, Dr Chris Hunter Medical data analysis and
Oldmeadow Research Institute preparation of publication [email protected] Pharmacy subject matter Senior Clinical expert, research design, Pharmacist/ Pharmacy provide expert advice on
Ged Hawthorn Educator, WNSWLHD clinical implementation [email protected] Senior Evaluation Officer, Health Intelligence Unit, Health measures, data
Dr Clare Coleman WNSWLHD extraction and analysis [email protected] Professor Clinical Research design and Prof Jo-Anne Brien Pharmacy, University of clinical implementation Sydney [email protected] Leadership in the design Mary Hoy and implementation of the Manager Pharmacy project in Far West LHD Services, FWLHD [email protected]
6.2 Research Governance and Partners The study will be overseen by a steering committee comprising of representatives from the following services and organisations:
- Western NSW Local Health District - Far West Local Health District - eHealth NSW - Centre for Aboriginal Health, NSW Health - Clinical Excellence Commission - Agency for Clinical Innovation
Throughout the duration of the study, the Advisory Group will be responsible for the oversight of strategic aspects of the project including operational and strategic management of project; advise on design, clinical implementation and translation of project within the setting of the larger eHealth agenda for NSW; ensure knowledge translation to assist with NSW health policy; ensuring the cultural appropriateness of the service for the Aboriginal community; and assessing the overall impact on patient outcomes or health and wellbeing of the rural and remote population. The group will meet at strategic milestones during the research period and maintain regular contact between meetings to facilitate feedback on specific issues via project updates.
6.3 Funding Funding for the project had been provided by the NSW Ministry of Health Translational Research Grant Scheme for the 2019-20 and 2020-21 financial years.
7 PROJECT DURATION AND TIME LINE The VCPS project activities will run for a total of 24 months from January 2020 to December 2021. See each intervention of the study for more specific information. The VCPS high level projected timeline is listed below.
Key Milestone Achievement Date Commence recruitment of key resources September 2019 13 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
Establishment of governance, committees and terms of reference October 2019
Ethics applications submitted with GWHREC November 2019 Project Implementation, change management and communication strategy development December 2019 Ethics applications submitted with AH&MRC January 2020 Commence site engagement and change management January 2020 Commence VCPS intervention and focus groups March 2020 Dissemination of research protocol and preliminary findings to key stakeholders December 2020 Continue post-intervention data collection June 2021 Data analysis and interpretation July 2021 Draft reports July 2021 Final reports August 2021 Submission of papers to journals and conference August to December presentations 2021
8 AIMS OF PROJECT The VCPS will evaluate virtual clinical pharmacy support to inpatient care in facilities in WNSWLHD and FWLHD where there is no access to on site clinical pharmacy services. The aim of the project is not to evaluate the effectiveness of clinical pharmacy services which is well defined in the literature.
9 RESEARCH QUESTIONS The VCPS aims to answering the following research questions:
1. Will the VCPS result in a detection of preventable medication harms and reduction of readmissions? 2. Will the VCPS improve compliance with NSQHS Standard 4 Medication Safety? 3. Is the VCPS cost-effective and will it demonstrate a positive return on investment? 4. Does the VCPS improve medication knowledge and compliance for patients, including Aboriginal & Torres Strait Islander peoples? 5. Is the VCPS perceived to be an acceptable service for patients and clinicians? 6. Will the VCPS be scalable to comparable health facilities?
10 PROJECT SETTINGS AND LOCATIONS 10.1 Site eligibility and selection For facilities to participate in the study they must meet the following criteria: Utilising the eMR and eMeds for medication management Not have access to on site clinical pharmacy services Not had previous intervention with virtual clinical pharmacy service Have sufficient patient activity to enable intervention. Patient says of greater than 24hrs was used as a surrogate marker of patient activity. o WNSWLHD: an average of greater than 20 patient stay per month of greater than 24 hours o FWLHD: an average of greater than 7 patient stay per month of greater than 24 hours
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Agree to participate in the study A total of eight health facilities from FWLHD and WNSWLHD will be included in the VCPS intervention. Two facilities will be located in FWLHD and six facilities located in WNSWLHD as per the Translational Research Grant Scheme application. While FWLHD only had two eligible sites, WNSWLHD had 10 eligible sites which were randomised to select the six study sites. The study site selection process is summarised below in Figure 8
Figure 8: VCPS site selection and randomisation 10.2 Study sites The sites listed below have been selected for inclusion. Each site will be approached and consented before joining the study. If a site does not wish to participate then the next eligible site will then be selected. FWLHD:
Balranald Multipurpose Service Wentworth Multipurpose Service WNSWLHD:
Bourke Multi-Purpose Service Warren Multi-Purpose Service Gilgandra Multi-Purpose Service Cobar District Hospital Canowindra Soldiers' Memorial Hospital Narromine District Hospital 15 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
10.3 Control sites Face to face pharmacy comparator sites will be required for the Patient Reported Experience Measures Survey (PREMS). Dubbo and Orange Hospital inpatient general medical wards will conduct PREMS surveys to act as a comparator.
11 VIRTUAL PHARMACY 11.1 Duration The virtual pharmacy intervention baseline data collection will begin February 2020 and intervention data from May 2020. Virtual pharmacy intervention data collection will continue for the stepped wedge analysis until December 2020. Post service implementation data collection and evaluation will then continue until June 2021.
11.2 Research design and methodology The virtual pharmacy intervention will be delivered using a stepped wedge cluster randomised trial design, where the intervention is sequentially implemented in the eight facilities. The ‘steps’ are the order in which each site cross-over from the control condition (pre-VCPS) to the intervention condition (VCPS). The sequence of the steps is also randomised, allowing for control of potential confounding temporal trends. This cross-over will occur across 8 steps (one site per step), each one month apart (with a two month ‘in-transition’ period) (see Fig. 9). The VCPS will be fully implemented after 11 months with all 8 hospitals receiving the VCPS. Process and outcome measures such as medication reconciliation, hospital readmissions, length of stay and falls data will be collected for baseline data from time period 1 and intervention data from time period 4. This pragmatic design, which is common to service delivery evaluations, is appropriate for interventions where simultaneous delivery of interventions is difficult and removal of the intervention would be inappropriate. A stepped wedge cluster randomised controlled design was chosen following successful piloting of virtual pharmacy and to prevent disappointment effects in hospitals not randomised to the intervention. The evaluation will use a mixed methods approach including embedded economic, qualitative and process measures.
Figure 9: VCPS stepped wedge cluster randomised control trial design. There are a total of 11 steps, with each step being one month apart. The light blue represent sites unexposed to the intervention (control). White represents sites where the service is being imbedded and no data will be used in the analysis. Dark blue represents sites exposed to the VCPS, and purple the service continuation and evaluation.
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11.3 Process and outcome measures The following routinely collected health data will be evaluated pre and post the virtual clinical service. Note that no data will be analysed in the transition period. The outcomes below should be read in conjunction with Table 1.
Level of Outcome Measure Data Source Data % medication reconciliation on admission eMR Report EM002 Facility % medication reconciliation on discharge eMR Report EM002 Facility VTE Prophylaxis rates HIU report Facility Antimicrobial usage iPharmacy Dispensing Software Facility % medication list on discharge Custom eMR report Patient 28 day readmission HIU report Facility 28 day readmission Aboriginal patients HIU report Facility Length of stay HIU report Facility Length of stay Aboriginal patients HIU report Facility Falls HIU report Facility Detection of preventable medication errors HIU report Facility Economic analysis (cost effectiveness) & scalability HIU reports Facility Level of Process Measure Data Source Data Number of medication reconciliation completed eMR report EM002 Facility Number of medication lists on discharge Custom eMR report Patient Number of referrals/ number of referrals completed eMR report PC011 Patient Pharmacist Interventions eMR DA2 Clinical Pharmacy Interventions Patient Time taken to undertake interventions eMR DA2 Clinical Pharmacy Interventions Patient Time taken to provide education eMR DA2 Clinical Pharmacy Interventions Patient Number of consultations eMR report PC011 Patient Uptake of pharmacy recommendations eMR DA2 Clinical Pharmacy Interventions Patient Number of pharmacist AMS reviews eMR report PC011/ eMR Report EM008 Patient
11.4 Patient Population The VCPS aims to provide equitable access to virtual pharmacy services for all patients admitted at rural and remote study sites. 11.4.1 Inclusion criteria Inpatients Emergency presentations 11.4.2 Exclusion criteria Outpatients Residential Aged Care Transitional Aged Care Hospital in the Home
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11.5 Potential for risk, burden and benefits 11.5.1 Risks There is a risk of breach of privacy for participants with virtual delivery as there is with face to face pharmacy services. To mitigate this risk clinical pharmacists will document patient notes directly into the eMR. Pharmacists will also utilise the secure end-to-end telehealth system in WNSWLHD which fulfils NSW data and privacy guidelines. All pharmacists will be credentialed within WNSWLHD facilities and will abide by NSW Health code of conduct and privacy policies (such as PD2015_049 NSW Ministry of Health Code of Conduct and WN_PD2013_026 WNSWLHD Access and Use of Health Information). There is a risk of failure of technology. To mitigate this the VCPS will utilise a range of modalities including tablet technology and designated telehealth equipment (‘Wallie’) to conduct reviews. In the event of downtime, telephone and fax will be utilised. In the event of an eMR downtime then relevant downtime procedures will be followed (WN_PD2018_050 Downtime Procedure for Electronic Medical Record Systems). The availability of the service could be limited if there are issues with recruitment and retention of qualified pharmacists to runs the VCPS.
11.5.2 Burdens Patients may not wish to have reviews over telehealth. Patient’s, as with face-to-face services may decline medication interviews and/or education sessions. Increased workload for staff making referrals to the VCPS There may be an increased workload placed on staff at the sites setting up the telehealth equipment and assisting when needed Increased utilisation of telehealth equipment Increased time for clinicians to manage pharmacist identified interventions
11.5.3 Benefits It is expected the intervention may: Improve medication management for inpatients in rural and remote facilities who otherwise would not have access to clinical pharmacy services Provide access to a clinical pharmacy service which will improve medication safety and reduce medication related harm Engage patients, increase involvement and understanding of medication regimen and encourage safe use of medicines Reduce the workload of inpatient clinical pharmacy services at neighbouring district or referral hospitals Improve facility compliance with NSQHS Standard 4- medication safety Reduce the need for patient transfer for specialist care, though identification of medication related harm 11.6 Consent
The Investigators are seeking a Waiver of Consent for the use of routinely collected health data (listed in section 11.3) for patient participants due to the high number of patients admitted to facilities over the study period. The Investigators believe a Waiver of Consent is suitable as set out in the national statement [32].
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The data collected will be de-identified, therefore there is sufficient protection of the participant’s privacy There is minimal foreseeable risk, including distress, to participants. Care provided will be as per established standards of pharmacy practice that are currently provided to patients with onsite pharmacy services. It is considered impractical to collect consent due to the large cohort of patients over the study period. The research is likely to be compromised if the participation rate is low, as results may not be indicative of the whole patient population, nor able to be translated to other rural areas. The data will be managed in accordance with relevant security standards to ensure protection of the confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server. There is a governance process and steering committee in place that has responsibility for appropriate data management. This study is of public interest with potential significance in furthering public knowledge in virtual pharmacy services and addressing the current inequity of access to healthcare for rural and remote patients. The findings will be communicated in scientific congresses and journal publications. This study also aims to address identified health priorities, of improving access to the right care, at the right time and as close as home as possible. The possibility of commercial use of derivatives of the data will not deprive the participants of any financial benefits. Regardless of consent procedure, participants would not be offered financial gain for participation in the study The Waiver is not prohibited by State, Federal or International Law. 11.7 Data management A large portion of the outcome measures are routinely collected data aggregated at a facility level which that poses minimal risk of patient identification. There are however still a number of process measure that will be collected at a patient level. Many of these measures will later be de-identified and pooled for analysis. All data will be managed in accordance with relevant security standards to ensure protection and confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server and maintained for 5 years as per the NHMRC requirements. Paper records will be securely stored in a locked filing cabinet with access restricted to VCPS research team. Patient level data created by the virtual clinical pharmacy interventions will be recorded in the patient’s clinical record on the eMR (PowerChart) as per standard face to face clinical pharmacy. This includes information relating to patient prioritisation, medication history and reconciliation, patient education, medication review and documentation and intervention recording. The electronic health record has sufficient security measures and policies in place to protect patient privacy. These include restricted access, password protection, privacy auditing and access levels set by position. Any eMR reporting will have patient names removed by the person generating the report, but will maintain medical record number, sex, date of birth and Aboriginal status for data validation, auditing and analytical purposes.
11.8 Sample size and data analysis 11.8.1 Quantitative analysis As per Table 1, there are 2 co-primary outcome variables: 1) the proportion of separations (“discharged home by the hospital”) where the medical reconciliation occurred on admission; and 2) the proportion of separations (“discharged home by the hospital”) where the medical reconciliation occurred on discharge. Secondary outcomes will include 28-day readmission, hospital length of stay 19 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
(LOS), number of falls and detection of medication-related errors. Our analyses will comprise generalised linear mixed models, with fixed effects for time, period (pre vs post), and patient-level confounding variables, as well as random effects for facility and patient to model clustering/repeat measures. Analyses will exclude separations where the patient is transferred to another facility. Power and sample size: Across the eight sites we conservatively estimate a referral rate of 29 patients per month yielding approximately 2088 patients over the stepped wedge intervention period. Assuming a baseline medical reconciliation rate on admission of 11% (a similar rate for discharge medical reconciliations), an intra-class correlation of 0.05, and an average of 29 patient separations per site per month,) we expect we would have over 90% power to detect an absolute 10% increase in the proportion of reconciliations performed on admission and discharge, with a type 1 error rate of 2.5%. 11.8.2 Economic analysis The economic analysis will consist of a cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA). These analyses will be conducted in accordance with international best-practice for such analyses in health care including: adoption a health sector perspective; transparent and scientific methods to identify, measure and value both costs and outcomes; modelling and uncertainty testing of input parameters; and, interpretation of results within a broader decision-making framework. The CEA will answer the question of whether the VCPS is more cost-effective than compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. Both analyses will rely on health care utilisation data outlined in Table 1 that identifies and measures resource use associated with the VCPS including: additional pharmacist time to deliver the intervention; patient and clinician education; and, any system level changes that have occurred to facilitate the implementation of the intervention. Resource use will be collected by the virtual clinical pharmacist and stored in the patient’s clinical record on the eMR (PowerChart) as per standard clinical practice. Change in 28 day re-admission will be used as the primary outcome in the CEA. The CBA will attempt to quantify a wider range of outcomes associated with the VCPS that can be valued in monetary terms such as LOS, the cost of treating adverse events (falls, medication-related errors) and potentially preventable admissions. Monte Carlo analysis will be used to derive 95% uncertainty intervals for costs and outcome with results presented in a scatterplot (i.e. cost-effectiveness plane). The results of the CEA will be considered in the context of other decision-making criteria such as: capacity of the intervention to reduce inequity; acceptability to stakeholders; feasibility; sustainability; and, potential for other consequences. Results of the CBA will be expressed as a ratio of benefits to costs whereby a benefit cost ratio > 1, suggests that the VCPS is a good return on investment.
12 PATIENT REPORTED EXPERIENCE MEASURES 12.1 Duration The Patient Reported Experience Measures Survey (PREMS) data collection will start March 2020 with the site transition period and continue through the intervention period and post intervention evaluation period until June 2021 at each study site. The first site will have 16 month data collection and the last site will have 9 months collection.
12.2 Research design and methodology A PREMS will be conducted with patients who have seen the virtual pharmacist. The PREM survey consists of 10 questions which will be delivered while the patient is in hospital using a device such as a tablet and the Customer Feedback Solutions electronic system.
The PREMS will be used to quantitatively assess improvements in patients’ knowledge and perceived acceptability of virtual pharmacy (Research Questions 4 and 5). The VCPS questions address patient communication of medication management during hospital admission, patient’s confidence managing medications and overall satisfaction with the VCPS (see Appendix 17.2). 20 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
To evaluate the acceptability of VCPS against face to face pharmacy services, PREMS will be conducted on the general medical wards at Dubbo and Orange Hospitals with patients who have seen a face to face inpatient pharmacist. The general medical ward was chosen as it will have the most similar patient population to the study sites. Data will be collected from the Dubbo and Orange sites between May 2020 and June 2021.
12.3 Process and outcome measures The following outcome and process measures will be used to assess the PREM surveys.
Outcome Measure Data Source Level of Data % overall score (facility level) Customer Feedback Systems Facility % overall score VCPS vs face to face pharmacy Customer Feedback Systems Facility % overall score VCPS vs face to face pharmacy for Facility Aboriginal patients Customer Feedback Systems PREMs results by question VCPS vs face to face pharmacy Customer Feedback Systems Facility
Process Measure Data Source Level of Data Total number of PREM surveys completed Customer Feedback Systems Facility Number of PREM surveys completed by location Customer Feedback Systems Facility PREMs results by question Customer Feedback Systems Facility Month on Month PREMS scores by question Customer Feedback Systems Facility
12.4 Patient Population 12.4.1 Inclusion criteria All inpatients and emergency presentations where the patient has seen the virtual pharmacist will be requested to complete the PREMS. The first question of the PREMS (did you see a pharmacist?) will be used to prevent patients unexposed to the service from completing the questionnaire.
A control arm of the study evaluating face to face pharmacy services will run Orange and Dubbo Health Services medical wards.
12.4.2 Exclusion criteria The following patient populations would not be asked to complete PREMS surveys:
Less than 18 years of age Do not speak English Communication problems that require specialist skills e.g. severe intellectual disabilities, brain injuries or dementia 12.5 Potential for risk, burden and benefits 12.5.1 Risks Staff at the study site do not offer the questionnaire to patients. This will be mitigated though extensive engagement, communication and change management. The virtual pharmacist will prompt site staff to offer the survey to patients after they have been seen. The devices used to administer the surveys could be lost, damaged, stolen or suffer failure. These risks will be evaluated at each site before the study period commences and appropriate mitigations put in place. Spare devices will be available if required.
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There is a very small risk to a patient could be identified (confidentiality) as the survey will collect demographic data of age, sex and Aboriginality. See data management for risk mitigation.
12.5.2 Burdens Patients may not wish to complete a short survey Increased workload for site staff setting up and offering survey
12.5.3 Benefits The survey is expected to provide evidence the study sites meets NSQHS standard 4.3 which is involving patients in care, meeting patient information needs and shared decision making The study is expected to demonstrate that virtual pharmacy is an acceptable mode of delivery for patients By demonstrating acceptability, the study has the capacity to develop a model of care that could easily be scaled and implemented in other local health districts across the state and country. 12.6 Consent The PREMS will use implied consent as an alternative to consent as outlined in the National Statement [32]. The investigators believe this meets the criteria for implied consent due to:
Consent is implied by the participant choosing to complete the survey Participation is voluntary Completion of the PREMS survey carries a low risk to participants, including distress. Participant information sheets (see Appendix 20.9 and 20.10) will be provided to participants providing a reasonable time to decline the survey. The participant information sheet provides a contact number to seek more information. The data collected will be de-identified, therefore there is sufficient protection of the participant’s privacy. The data will be managed in accordance with relevant security standards to ensure protection of the confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server. There is a governance process and steering committee in place that has responsibility for appropriate data management. This study is of public interest with potential significance in furthering public knowledge in virtual pharmacy services and addressing the current inequity of access to healthcare for rural and remote patients. The findings will be communicated in scientific congresses and journal publications The implied consent approach is not prohibited by state, federal, or international law.
12.7 Data management All data will be managed in accordance with relevant security standards to ensure protection and confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server and maintained for 5 years as per the NHMRC requirements. Paper records will be securely stored in a locked filing cabinet with access restricted to VCPS research team. The PREMS data will be collected from patients using a portable device (e.g. tablet) electronically. If necessary (e.g. vision impairment) a member of the project team could manually enter the results into the Customer Feedback Systems (CFS) platform. This platform is used by WNSWLHD for the collection, secure storage and reporting of patient reported measures. All patient responses are data
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aggregated at a facility level as the hospital location is required for site to site comparison. The survey participants are anonymous but does collect age, sex and Aboriginality for demographic analysis of the results.
12.8 Sample size and data analysis All patients receiving the VCPS will be invited to complete the PREMS (estimated n = 500 completed). All inpatients receiving an inpatient face to face pharmacy service on the medical wards at Orange and Dubbo hospitals within a 3 month time period (to be negotiated with the sites) between March 2020 and June 2021 will be asked to complete the PREMS (estimated n = 500 completed). A sample of this size will allow us to detect differences in responses between demographic sub-groups of at least 0.3 standard deviations (i.e. a moderate effect size), with 90% power and 5% type 1 error rate. Descriptive statistical analysis will summarise patient answers, and linear regression models will be used to explore characteristics associated with the overall score (using age, sex and Aboriginality as independent variables).
13 PATIENT MEDICATION ADHERENCE QUESTIONNAIRE (MMAS-8) Medication adherence refers to whether a patient takes their medications as prescribed and is a primary determinant of treatment success. Poor adherence to medications is common in patients with chronic disease and in patients prescribed preventative medications.
The 8 question Morisky Medication Adherence Scale (MMAS-8) is validated to identify adherence behaviour in a number of chronic disease populations and scores have been show to correlate well with objective measures and clinical outcomes [34]. The tool uses short behavioural questions, asked in a way to avoid yes bias seen in chronic care patients. It also has the wording of questions rearranged to prevent answers that follow certain behavioural patterns to allow the patient to respond to questions about non-adherence with full disclosure. If the patient scores higher on the scale they are evaluated as more adherent. If the patient scores lower on the scale they are presumed to be struggling with non-adherence.
13.1 Duration The MMAS-8 data collection will start March 2020 with the site transition period and continue through the intervention period and post implementation evaluation period until June 2021 at each study site. The first site will have 16 month data collection and the last site will have 9 months collection.
13.2 Research design and methodology The MMAS-8 will be administered to patients on admission to study sites pre and post the VCPS intervention electronically via Customer Feedback Systems. The MMAS-8 will then be repeated 4 weeks post discharge to assess changes in medication adherence due to the VCPS. Follow up MMAS- 8 will be administered via text message invitation requesting the patient complete the questionnaire electronically via the Customer Feedback Systems platform.
13.3 Process and outcome measures The following outcome and process measures will be used to assess the MMAS-8:
Level Of Outcome Measure Data Source Data Change in adherence score pre and post VCPS Customer Feedback Systems Patient Change in adherence score control vs VCPS Customer Feedback Systems Patient
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Change in adherence score control vs VCPS for Aboriginal patients Customer Feedback Systems Patient Patient Process Measure Data Source level data Total number of MMAS-8 completed Customer Feedback Systems Facility MMAS-8 % response rate Customer Feedback Systems Facility
13.4 Patient Population 13.4.1 Inclusion criteria All inpatients and emergency presentations will be eligible to complete the MMAS-8.
13.4.2 Exclusion criteria The following patient populations would not be suitable for MMAS-8: Less than 18 years of age Do not speak English Communication problems that require specialist skills e.g. severe intellectual disabilities, brain injuries or dementia 13.5 Potential for risk, burden and benefits 13.5.1 Risks There is a risk to patient privacy. See data management for risk management. While it is not foreseen, patients may become distressed by the survey. If this occurs the pharmacist will counsel the patient, provide further explanation and cease the survey if the patient wishes.
13.5.2 Burdens Patients may not wish to complete short survey
13.5.3 Benefits The provision of the survey is one mechanism to engage patients, increase involvement and understanding of medication regimen and encourage the safe use of medicines. The survey is expected to provide evidence the study sites meets NSQHS medication safety standard 4. By demonstrating improved medication adherence, the study has the capacity to develop a model of care that could easily be scaled and implemented in other local health districts across the state and country. 13.6 Consent The MMAS-8 will use implied consent as an alternative to written consent as outlined in the National Statement [32]. The investigators believe this meets the criteria for implied consent due to:
Consent is implied by the participant choosing to complete the survey Completion of the MMAS-8 survey carries a low risk to participants, including distress. Participant information sheets (see Appendix 20.9) will be provided to participants providing a reasonable time to decline the survey. The participant information sheet provides a contact number to seek more information.
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The data collected will be de-identified, therefore there is sufficient protection of the participant’s privacy. The data will be managed in accordance with relevant security standards to ensure protection of the confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server. There is a governance process and steering committee in place that has responsibility for appropriate data management. This study is of public interest with potential significance in furthering public knowledge in virtual pharmacy services and addressing the current inequity of access to healthcare for rural and remote patients. The findings will be communicated in scientific congresses and journal publications The implied consent approach is not prohibited by state, federal, or international law.
13.7 Data management All data will be managed in accordance with relevant security standards to ensure protection and confidentiality of the data. All computerised data will be kept on a limited access drive on a secure WNSWLHD Server and maintained for 5 years as per the NHMRC requirements. Paper records will be securely stored in a locked filing cabinet with access restricted to VCPS research team. As the MMAS-8 will be provided to patient’s pre and post VCPS, data linkage is required. To maintain confidentiality patient names will be recorded separately to the survey results to maintain confidentiality. The master list will be stored on a restricted access drive and the file password protected. Once the pre and post data is matched then the data will be de-identified by the research team.
13.8 Sample size and data analysis A sample of 75 patients in the pre period and 75 patients in the post period (across all sites) will give the study 85% power to detect an increase in adherence of 0.5 standard deviations (a moderate effect size), with a type 1 error rate of 5%.
A list of eligible patients that are admitted will be used as a sampling frame, and patients will be randomly selected from this frame using a computerised program, and approached to complete the MMAS-8. The patients will also be sent a link to the survey 4 weeks post discharge (see Appendix 20.3.11).
Characteristics of patients responding in each period will be compared using independent sample t- tests (for continuous variables) or chi-square tests (for categorical variables). Differences in adherence between patients in the pre period and patients in the post period will be compared using linear regression models, adjusting for patient characteristics that may have changed between the periods
14 STAFF FOCUS GROUPS 14.1 Duration A staff focus group will be held at each participating site 3 months after the beginning of the VCPS transition period. Therefore the first site focus group will be held in May 2020 and the last focus group in January 2021.
14.2 Research design and methodology The focus group will aim to address the perceived acceptability of the service for staff (research question 5). All LHD staff who work in clinical areas where the VCPS operates will be asked to participate in the focus group. Senior staff and managers’ will participate in a separate focus group 25 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
to all other staff to take into account potential power relationships that may inhibit the responses of junior staff. The focus group will be held three months after the VCPS commences to provide adequate time for staff to be exposed to the service and go through the stages of change. The focus group discussion will be qualitative and aim to explore the issues, benefits, barriers and overall acceptability of the VCPS (see Appendix 20.4 and 20.5).
14.3 Process and outcome measures The following measures will be used to evaluate staff acceptability of the VCPS:
Outcome Measure Data Source Level of Data
Thematic analysis Manual Facility
Thematic analysis site comparison Manual Facility
Process Measure Data Source Level of Data
Total number of staff participants Manual Facility
14.4 Participant Population 14.4.1 Inclusion criteria All health professionals such as nurses, doctors, allied health assistants, Aboriginal liaison officers and managers who work in clinical areas where the VCPS operates will be asked to participate in the focus group Staff must be employed by the Local Health District to participate Aged 18 years or over
14.4.2 Exclusion criteria Students on placements will be excluded from the focus group
14.5 Potential for risk, burden and benefits 14.5.1 Risks Not enough staff will be available to participate in focus groups. The research team will work with sites to enable rostering and holding the focus group at a time to enable maximum staff participation. There is a risk to staff member confidentiality as it is a group session. It will be explained at the beginning of the focus groups that the contents of the session are confidential and not to be discussed outside of the focus group. While the research team will not disclose any information, due to the nature of focus groups confidentiality cannot be guaranteed. Participation in the focus group is not anticipated to cause any distress and no personal experiences with medication errors are required to be disclosed. However, should a participant become distressed they will be supported by a member of the research team outside the group meeting, until their distress subsides. They will be provided with details of Employee Assistance Program to access further support if required.
14.5.2 Burdens Disruption to clinical duties for staff attending focus groups
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14.5.3 Benefits The study is expected to demonstrate that virtual pharmacy is an acceptable mode of delivery for staff including doctors and nurses. By demonstrating staff acceptability to virtual pharmacy, the study has the capacity to develop a model of care that could easily be scaled and implemented in other local health districts across the state and country. 14.6 Consent The staff focus group will require written consent from participants. Each participant will be given a Participant Information Sheet and complete a Consent Form prior to participation in the focus groups.
14.7 Data management All focus group participants will remain anonymous and responses not linked to individuals. Any publication will omit statements that may identify an individual. Site location will be recorded for site to site comparison. Transcripts and recordings will be kept on a WNSWLHD secure server only accessible by the research team. Focus group consent forms will be securely stored with access restricted to the research team. Data will be destroyed after 7 years by the chief investigator.
14.8 Sample size and data analysis A strengths-based approach called ‘appreciative enquiry’ (an organisations change based methodology) will be used to undertake focus groups with participating staff (n=10 approximately). The focus groups will be audio-recorded, transcribed verbatim and entered into QSR NVivo. Thematic analysis will be utilised to deductively and inductively identify barriers and facilitators, but open to unexpected findings that may contribute to these in each of the study sites.
15 PROJECT OUTCOMES A summary of the key process and outcome measures are outlined in Table 1. Table 1: Process and outcome measure of the VCPS
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16 OUTCOMES AND SIGNIFICANCE 16.1 Providing world-class health care closer to home A number of small-scale studies have assessed the feasibility and acceptability of telepharmacy services in rural and remote locations [21-24]. This study will add to existing literature to provide evidence to the feasibility and efficacy of such services in relation to patient outcomes (medication compliance, 28-day readmission, reductions in medication errors), organisational priorities (compliance with NSQHS Standard 4) and economic factors. Additionally, the VCPS will provide access to the expertise of a clinical pharmacist for inpatients in rural and remote facilities who otherwise would not have it. Inpatient clinical pharmacy services have been proven to optimise medication management and minimise medication-related harm. If this research project finds similar benefits, we will be improving access to an essential health service in a disadvantaged subset of the rural and remote population. Furthermore, through ensuring the VCPS is culturally safe and appropriate for Aboriginal peoples (see Appendix 20.6 Aboriginal Health Impact Statement), we expect this project to provide a model that can assist with medication literacy and concordance amongst Aboriginal patients who present to participating facilities. All rural and remote Australians, including Aboriginal peoples, have a shorter life expectancy and a more significant burden of chronic disease which equates to greater polypharmacy and a higher risk of medication-related harm [26]. It is widely recognised that clinical pharmacists are best placed to reduce rates of medication error [25]; however, the workforce is poorly integrated into rural and remote health facilities [15, 16]. This project will help provide evidence as to ways in which the proven benefits of hospital pharmacists can be maximised within current limitations on workforce utilising telehealth technology.
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16.2 Tangible benefits to patients This project is expected to demonstrate measurable outcomes in reducing preventable admissions to hospital, minimising medication-related harm, improving medication-related communication on transfer of care to primary care providers, empowering patients with a better understanding of their medications, improve concordance with medication management and improving evidence-based prescribing (including antimicrobial stewardship).
16.3 Smaller facilities having equitable access to pharmacy services to meet accreditation The introduction of the NSQHS Standards has increased the focus on medication safety and the role of pharmacy in supporting best practice medication management. Both FWLHD and WNSWLHD experience challenges meeting accreditation, specifically around Standard 4. The VCPS offers a solution to improve compliance with Standard 4 and more importantly improve the delivery of safe and high-quality healthcare regardless of where a patient presents. 16.4 Effectiveness and potential scalability of the VCPS There is currently limited published evidence on the effectiveness of a virtual or telehealth pharmacy service [15, 16]. From the publications that do exist, evidence is focused on management of chronic disease in an outpatient setting or remote dispensing. This research will generate new evidence in the provision of an inpatient clinical pharmacy service to under-resourced rural and remote health facilities. This project has the capacity to develop a model of care with proven quantitative, qualitative and economic impacts that could easily be scaled and implemented in other local health districts across the state and country.
17 ETHICAL APPROVAL Greater Western Human Research Ethics Committee (GWHREC) and the Aboriginal Health and Medical Research Council (AH&MRC) will provide ethical approval before the study commences.
18 DISSEMINATION OF RESULTS AND PUBLICATIONS The results will be prepared and submitted to Journals for publication. Where possible open access publication will be sought to ensure equitable dissemination of information. Results will also be published in a report for conferences (e.g. SHPA and NRHA), network meetings and to relevant stakeholders (e.g. Western PHN, Bila Muuji Aboriginal Corporation, ACI, CEC, other LHDs). Translation of results will be pursued in partnership NSW Health and WNSWLHD.
19 REFERENCES 1. Mekonnen AB, McLachlan AJ, Brien JE. (2016). Effectiveness of pharmacist-led medication reconciliation programmes on clinical outcomes at hospital transitions: a systematic review and meta-analysis. BMJ Open; 6:e010003. doi:10.1136/bmjopen-2015- 010003. 2. Ravn-Nielsen LV, Duckert M, Lund ML, et al. (2018). Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission: a randomized clinical trial. JAMA Intern Med. doi: 10.1001/jamainternmed.2017.8274. 3. Duguid M. (2012). The importance of medication reconciliation for patients and practitioners. Aust Prescr; 35: 15-9. 4. The Society of Hospital Pharmacists of Australia. SHPA Standards of practice for the provision of medication reconciliation. (2007). J Pharm Pract Res; 37: 231-3. 5. Australian Commission on Safety and Quality in Health Care. (2011). Medication Reconciliation. Sydney: ACSQHC.
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6. Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Clinical Pharmacy - SHPA Standards of Practice for Clinical Pharmacy Services. (2013). J Pharm Prac Res 2013; 43(2): s2-s5 7. World Health Organization (WHO). (2014). The High 5s Project Interim Report. Geneva. World Health Organization. 8. Australian Commission on Safety and Quality in Health Care. (2014). High 5s Project Assuring Medication Accuracy at Transitions of Care – Australian Interim Report January 2010–March 2013. ACSQHC Sydney. 9. Scott DM, Friesner DL, Rathke AM, Doherty-Johnsen S. (2014). Medication error reporting in rural critical access hospitals in the North Dakota Telepharmacy Project. Am J Health System Pharm, 71, 58-67. 10. Zermansky AG, Silcock J. (2009). Is medication review by primary-care pharmacists for older people cost effective?: a narrative review of the literature, focusing on costs and benefits. `Pharmacoeconomics; 27(1):11–24. 11. Jetha S. (2015). Polypharmacy, the elderly, and deprescribing. Consult Pharm J Am Soc Consult Pharm. 30(9):527–532. 12. Horne R, Weinman J, Barber N, et al. (2005). Concordance, adherence and compliance in medicine taking: report for the National Coordinating Centre for NHS Service Delivery and Organisation R&D. London: NCCSDO. 13. Roughead E, Semple S, Rosenfeld E. (2013). Literature Review: Medication safety in Australia 2013. ACSQHC. 14. Duguid M, Gibson M, O'Doherty R. (2002). Review of discharge prescriptions by pharmacists integral to continuity of care [letter]. J Pharm Pract Res 32:94-5. 15. Tan A, Emmerton L, Hattingh L. (2012). Issues with medication supply and management in a rural community in Queensland. Aust J Rural Health, 20(3):138-43. doi: 10.1111/j.1440- 1584.2012.01269.x. 16. Tan A, et al. (2012). Medication supply and management in rural Queensland: views of key informants in health service provision. Res Social Admin Pharm; 8(5); 420-432. 17. Arkinstall R, N Muscillo, Lum E. (2009). Medication Management Issues for Nurses Working I n Rural and Remote Areas. Brisbane: Medication Services Queensland. 18. Submission to the Productivity Commission: The Health Workforce (2005). Australian Government Productivity Commission, Collingwood. 19. NHS England (2016). Transformation of seven day clinical pharmacy services in acute hospitals. NHS, London. 20. Caffery LJ, Bradford NK, Wickramasinghe SI, Hayman N, Smith AC. (2017). Outcomes of using telehealth for the provision of healthcare to Aboriginal and Torres Strait Islander people: a systematic review. Aust NZ J Public Health ; 41:48-53; doi: 10.1111/1753-6405.12600. 21. ‘Telepharmacy’ Growing in Australia. Australian Journal of Pharmacy. Accessed on 27 Jan 2019 https://ajp.com.au/news/telepharmacy-growing-australia/ 22. Poudel A, Nissen LM. (2016). Telepharmacy: a pharmacist’s perspective on the clinical benefits and challenges. Integrated Pharmacy Research and Practice; 5(1):75-82 23. Poulsen LK, Nissen L, Coombes I. (2010). Pharmaceutical review using telemedicine – a before and after feasibility study. Journal of Telemedicine Telecare; 16 (1): 95-99 24. McFarland R. (2017). Telepharmacy for remote hospital inpatients in north-west Queensland. J Telemed Telecare, 23(10):861-865. doi:10.1177/1357633X17732367. 25. Rothwell, M (2017). Clinical Pharmacists connecting with patients in rural and remote towns via telehealth. National Rural Health Conference, Darwin 26. Australian Institute for Health and Welfare. (2017) Rural and Remote Health Report. 27. Tong EY, Roman CP, Mitra B, Yip GS, Gibbs H, Newnham HH, Smit DV, Galbraith K, Dooley MJ (2017). Reducing medication errors in hospital discharge summaries: a randomised controlled trial. The Medical Journal of Australia; 206 (1): 36-39. doi: 10.5694/mja16.00628.
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28. Searles A, Doran C, Attia J, et al. An approach to measuring and encouraging research translation and research impact. Health Res Policy Syst 2016;14:60. 29. Milat AJ, Bauman AE, Redman S, Curac N. Public health research outputs from efficacy to dissemination: a bibliometric analysis. BMC Public Health. 2011;11:934. doi:10.1186/1471- 2458-11-934.health promotion interventions into policy and practice. 30. Paxton Partners 2016 report for WNSWLHD (internal document). 31. Australian Commission on Safety and Quality in Health Care. National Safety and Quality Health Service Standards. 2nd ed. Sydney: ACSQHC; 2017. 32. National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research. In: National Health and Medical Research Council, editor. Canberrra, ACT: National Health and Medical Research Council,; 2007 (Updated 2018). 33. Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny M, Sheikh A, Medication without Harm: WHO’s third Global Patient Safety Challenge, The Lancet, 2017;389: 1680-1681. doi: https://doi.org/10.1016/S0140-6736(17)31047-4 34. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67–74.
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20 APPENDICES
20.1 Glossary of abbreviations
ACI Agency for Clinical Innovation AH&MRC Aboriginal Health and Medical Research Council AMS Antimicrobial stewardship review CBA Cost-benefit analysis CEA Cost-effectiveness analysis CEC Clinical Excellence Commission CFS Customer Feedback Systems DA2 eMR Discern Analytics 2 reporting tool Electronic medication management eMeds (part of the Cerner eMR) Electronic medical record eMR (including Cerner Millennium PowerChart and FirstNet) FWLHD Far West NSW Local Health District GWHREC Greater Western Human Research Ethics Committee HIU Health Intelligence Unit, WNSWLHD LHDs Local Health Districts MMAS-8 8 question Morisky Medication Adherence Scale Med Rec Medication reconciliation MMP or Medication Management Plan/ electronic Medication eMMP Management Plan NHRA National Rural Health Alliance NSQHS National Safety & Quality Health Service Standards PFML Patient friendly medication list PREMS Patient Reported Experience Measures Survey SHPA Society of Hospital Pharmacists of Australia VCPS Virtual clinical pharmacy service VTE Venous thromboembolism WNSWLHD Western NSW Local Health District
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20.2 Patient reported experience measures survey 20.2.1 PREMS survey invitation We are interested in your experience with the virtual pharmacy service and you can help the hospital improve services.
This survey takes about 5 minutes to complete. Participation is voluntary and all responses are confidential. This survey is being conducted by Customer Feedback Systems (CFS) on behalf of …… hospital.
20.2.2 PREMS survey questions Virtual Clinical Pharmacy Service Patient Experience Survey Questions
Did a pharmacist discuss your medicines with you during your 1 stay in hospital? Yes No If you talked to the pharmacist through videoconferencing, how would you rate the quality of the very very Not 2 picture and sound? good okay Neutral poor poor Applicable
The pharmacist talked to me in a Strongly Strongly 3 way I could understand agree Agree Neutral Disagree disagree Following your discussion with a little the pharmacist, how would you bit Much rate your confidence in worse about better better managing your medications at than the than than 4 home? before same Neutral before before I was involved as much as I wanted in making decisions about my medications while in Strongly Strongly 5 hospital? agree Agree Neutral Disagree disagree How likely are you to recommend the pharmacy neither service to your friends and very likely or 6 family? likely likely unlikely unlikely Not sure Overall, how would you rate your experience of care with the Very 7 Pharmacist? Excellent good Good Fair Poor prefer not to 8 Please select your gender female male say
9 What is your age? Prefer Are you Aboriginal and/or Torres not to 10 Strait islander? Yes No say
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20.3 Patient Medication Adherence Questionnaire (MMAS-8) 20.3.1 MMAS-8 survey invitation script This is a follow up survey to see how you are managing you medications after your recent admission to …. Hospital. You may recall receiving a participant information sheet while in hospital which explained this is part of a research study. The survey takes about 5 minutes to complete. Participation is voluntary and all responses are confidential. This survey is being conducted by Customer Feedback Systems (CFS) on behalf of …… hospital.
20.3.2 MMAS-8 Questions No= 0 Yes= 1 1 Do you sometimes forget to take your medications? People sometimes miss taking their medications for 2 reasons other than forgetting. Over the past 2 weeks, were there any days when you did not take your medication? Have you ever cut back or stopped taking your 3 medication without telling your doctor, because you felt worse when you took it?
4 When you travel or leave home, do you sometimes forget to bring your medication? 5 Did you take all your medication yesterday? When you feel like your symptoms are under 6 control, do you sometimes stop taking your medication? Taking medications every day is a real 7 inconvenience for some people. Do you ever feel hassled about sticking to your treatment plan? How often do you have difficulty remembering to Never/Rarely 0 take all your medications? Once in a while 1 8 Sometimes 2 Usually 3 All of the time 4
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20.4 Focus group questions To be completed 3 months After Virtual Clinical Pharmacy Service has commenced at the site.
1. The virtual pharmacy has been operating for 3 months at this site. What was the implementation like? (Prompt – how were you informed about it? How it would work? How to refer patients?) (service delivery) 2. What is your experience of the virtual clinical pharmacy service? (Prompt - has the virtual clinical pharmacy service changed what you do with patients? Problems with performing routine tasks or changes in routine) (Employee experience) 3. What was your experience of availability of a clinical pharmacist for medication review and medication advice prior to the virtual service? (employee experience) 4. What problems have you experienced here associated with medication review, medication advice, reactions or changes to medications when a pharmacist is not available? (Prompt – what do staff need to know about meds?) (employee experience) 5. Can you describe any benefits for patients? (prompt – Compliance with meds, understanding of meds, availability of pharmacist, ask for examples) (Employee experience) 6. What about problems for patients? Can you give any examples? (Employee experience and service delivery) 7. How well do you think the structure and management of virtual pharmacy are working? Can you recommend any changes? (service delivery)
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20.5 Staff focus group information sheet and consent form
Dr Shannon Nott Rural Director of Medical Services Western NSW Local Health District Dubbo NSW AUSTRALIA T: +61 (2) 6378 6272 E: [email protected]
Participant Information Sheet Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
Project team: Shannon Nott, Ged Hawthorn, Brett Chambers, Mary Hoy, Chris Doran, Chris Oldmeadow, Jo-Anne Brien, Julaine Allan
Organisations: Western NSW Health District, Far West Health District Central QLD University, Hunter Medical Research Institute, University of Sydney Hello, We are doing a research project to evaluate the Virtual Clinical Pharmacy Service (VCPS) that is being delivered to 8 hospitals in Western and Far West NSW LHDs via a video link. The aim of the virtual pharmacy is to improve medication management, reduce medication harm, help patients manage their medications, and support staff with patients. We are asking you to be in our project because your workplace has been involved in the project. We are interested to understand how the service has been provided and your experience with it. You are invited to participate in a focus group discussion to describe your experiences in using the WNSWLHDs virtual clinical pharmacy service. You are invited to take part in this discussion because you work in wards of the health facility where the virtual clinical pharmacy service operates. This sheet tells you what is involved with taking part in the project. Please read it carefully so that you can make up your mind about whether you want to take part. If you decide to take part in the research, you will be asked to take part in a focus group discussion, lasting up to 30 minutes, about your experience with virtual pharmacy services to inpatients and emergency presentations in your health facility. During the focus group, two members of the research team will be present - one team member will facilitate the discussion and the other will take notes of the key points. The discussion will be recorded using an audio recording device for data capture and analysis purposes. You will not be able to participate in this study if you do not agree to the information being recorded. You can leave the group at any time if you no longer wish to participate. The focus group will take place in a meeting room at your workplace. Who is doing this project? The project team includes representatives from these organisations: Western NSW LHD, Far West NSW LHD, Central QLD University, Hunter Medical Research Institute and the University of
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Sydney. This project is funded by the NSW Ministry of Health Translational Research Grants Scheme. What will happen with the information collected during this project? The research team will record all focus group discussions and write them up word for word. Once all the recordings are transcribed, the transcripts will be analysed to identify key themes. These themes will be highlighted in an evaluation report that will not identify individuals. We may also develop a report and submit it to an academic journal for publication. No services or individuals will be identifiable in these reports. Do I have to participate in this project? No. Participation is voluntary. If you decide you want to be in the project and then you change your mind later, that’s ok. All you need to do is tell us that you don’t want to be in the project anymore. You can withdraw consent and stop the project at any time without giving reasons and without any penalty. This will not affect your relationship with the project team or your employer. Will anyone else know what I say in the project? We won’t tell anyone else what you say to us but the other people in the focus group will know what you said. Although we will ask participants to respect the confidentiality of what is said, due to the nature of focus groups, we cannot absolutely guarantee this. All of the information that we have from the project will be stored in a safe place and we will look after it carefully. In our report about the project we won’t say your name, or your worksite’s name and no one will know that you were in the project. How long will it take to be involved in this project? It will take up to 30 minutes to complete the focus group discussions. Are there any good things about being in the project? You won’t get anything for being in the project. We think this project will benefit the community by developing recommendations for best practice. This will help Western NSW Local Health District and other health services to do their work better, by enhancing the care provided around medications. Are there any bad things about being in the project? This project will take up some of your time, but it won’t cost you anything or cause any problems. You will not need to talk about personal experiences with medications or your own health. What if I am not happy with the project or the people doing the project? This research has been approved by the Greater Western Area Human Research Ethics Committee. Anyone with any concerns or complaints may contact the Committee’s Executive Officer on (02) 6330 5948 or by email [email protected] and quote reference 2019/ETH13355.
Alternatively you may contact Shannon Nott (project supervisor) on (02) 6378 6272 or email [email protected]
This sheet is for you to keep.
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Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
PARTICIPANT CONSENT FORM I, ………………………………………………………………….. [PRINT NAME], agree to take part in this research study and to the audio recording of the session.
You can say no.
In giving my consent, I state that: I have discussed my involvement in the project with the researcher/s and had any questions answered. I understand I am volunteering to participate and have been invited because of my work role I understand that my name or personal details are not required. I understand that I can withdraw at any time during the discussion and withdrawal will not affect my current role/employment and/or research team members. I understand and consent to the focus group discussion being audio recorded and my contribution cannot be excluded from the recording if I choose to withdraw my consent. I understand that the results of this study will be published or presented at a conference for the public.
Name (Please Print): ......
Signature:...... Date: ......
Name of Person who conducted informed consent discussion (Please Print):
…………………………………………………………………………………………
Signature of Person who conducted informed consent discussion:
Signature:...... Date: ......
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20.6 Aboriginal health impact statement
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20.7 Essential research partners
Name Position Organisation Contribution to project
Mr Richard Executive WNSWLHD Executive Sponsor Cheney Director of Allied Health
Dr Emma Senior Lecturer University of Research design, qualitative measures Webster Rural Research Sydney and data analysis
Dr Senior Lecturer University of Research design and data analysis Georgina Rural Health Sydney Luscombe
Mr Executive WNSWLHD To provide leadership and advice on the Brendon Director of design and implementation of the project Cutmore Aboriginal to ensure that the service is culturally Health and appropriate for Aboriginal peoples and Wellbeing delivers a net benefit for Aboriginal patients
Mr Ronan Principal Project eHealth NSW To provide high-level advice on the Herlihy Manager, design, implementation and translation of Innovation the project within the setting of the larger eHealth agenda for NSW. This includes the application for this model in the pending eMeds implementation
Mr Phillip Principal Centre for To provide expert cultural advice to Bannon Advisor Aboriginal ensure the VCPS is culturally acceptable Health, NSW for Aboriginal patients accessing Health treatment in the remote facilities. Further, to ensure two-way knowledge translation about the outcomes of the project throughout the research duration which will assist with NSW Health policy engagement and change if found effective
Dr Peter Clinical Advisor eHealth NSW To provide high-level advice on the Kennedy design, implementation and translation of the project within the setting of the larger eHealth agenda for NSW. This includes the application for this model in the pending eMeds implementation
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Ms Nina Senior Manager, Clinical To provide high-level advice on the Muscillo Medication Excellence design, implementation and translation of Safety Commission the project within the setting of the CEC’s medication safety framework
Dr Harvey Director, Clinical To provide high-level advice on the Lander Systems Excellence design, implementation and translation of Improvement Commission the project within the setting of the CEC’s broader work across NSW
Mr Raj Director of Agency for To provide high-level advice on the Verma Clinical Program Clinical design, implementation and translation of Design and Innovation the project within the setting of ACI’s Evaluation Telehealth Strategic Advisory Group and its broader program design and evaluation directorate
Ms Jenny Rural Health Agency for To provide advice regarding the design, Preece Manager Clinical implementation and translation of the Innovation project within the setting of innovations across rural NSW
Ms Donna Telehealth Agency for To translate outcomes of the project Parkes Manager Clinical within the broader NSW Telehealth Innovation Framework
Dr Clayton District Director WNSWLHD To provide leadership in the design and Spencer of Medical implementation of the project in WNSW Services LHD from an Executive perspective
Dr Andre Director of FWLD To provide leadership in the design and Nel Medical implementation of the project in FWLHD Services from an Executive perspective
Mr Ian District Director WNSWLHD To provide leadership and advice in the Mawbey of Pharmacy design and implementation of the project in WNSW LHD from a pharmacy perspective
Ms Prue Deputy-Director, WNSWLHD To provide advice in the design and Kevans Orange Health implementation of the project in WNSW Service LHD from a pharmacy perspective Pharmacy
Mr Kelvin Deputy-Director, WNSWLHD To provide advice in the design and Chan Dubbo Base implementation of the project in WNSW Hospital LHD from a pharmacy perspective Pharmacy
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Ms Sharon Director, Rural WNSWLHD To provide leadership in the design and McKay Health Services implementation of the project in WNSW LHD from an operations perspective for Rural Sectors across WNSWLHD
Ms Dale Director of FWLHD To provide leadership in the design and Sutton Nursing implementation of the project in WNSW LHD from an operations perspective for FWLHD
Ms Nurse Manager Far West To provide leadership in the design and Jacqueline Policy, Practice LHD implementation of the project in Far West Ballard and Initiatives LHD from a nursing perspective
Ms Lauren Practice WNSWLHD To provide advice surrounding how this Herd Improvement project can address accreditation and Standard 4 for rural health facilities Accreditation Standards Officer
Mr Clinton Manager WNSWLHD To provide advice in the design and Grose Nursing Policy, implementation of the project in WNSW Practice and LHD from a nursing perspective Initiatives
Ms Anne District Manager WNSWLHD To provide leadership and advice in the Taylor Virtual CARE design and implementation of the project in WNSW LHD from a virtual health service perspective
Mr Louis eMeds Clinical WNSWLHD, To provide advice on the design and Botha Application FWLHD, implementation of the project within the Specialist SWSWLHD, context of the broader Rural eMeds (Team Lead) MLHD initiative
Ms Sharyn Health ICT WNSWLHD To ensure that HICT technical Cowie Manager, requirements are implemented in the Telehealth design and panning of the project. Also to provide technical support during implementation.
Ms Amelia Rural Health WNSWLHD To link this project with other innovative Haigh Innovation Lead projects across rural sites in WNSWLHD and to ensure appropriate project outcomes are obtained
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20.8 NSQHS Medication Safety Standard 4 4. Medication Safety Leaders of a health service organisation describe, implement and monitor systems to reduce the occurrence of medication incidents, and improve the safety and quality of medicines use. The workforce uses these systems. Intention of this standard The Medication Safety Standard aims to ensure that clinicians safely prescribe, dispense and administer appropriate medicines, and monitor medicine use. It also aims to ensure that consumers are informed about medicines, and understand their own medicine needs and risks. Criteria Clinical governance and quality improvement to support medication management Organisation-wide systems are used to support and promote safety for procuring, supplying, storing, compounding, manufacturing, prescribing, dispensing, administering and monitoring the effects of medicines. Integrating clinical governance Action 4.1 Applying quality improvement systems Action 4.2 Partnering with consumers Action 4.3 Medicines scope of clinical practice Action 4.4 Documentation of patient information A patient’s best possible medication history is recorded when commencing an episode of care. The best possible medication history, and information relating to medicine allergies and adverse drug rations are available to clinicians. Medication reconciliation Action 4.5 Action 4.6 Adverse drug reactions Action 4.7 Action 4.8 Action 4.9 Continuity of medication management
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A patient’s medicines are reviewed, and information is provided to them about their medicines needs and risks. A medicines list is provided to the patient and the receiving clinician when handing over care. Medication review Action 4.10 Information for patients Action 4.11 Provision of a medicines list Action 4.12 Medication management processes Health service organisations procure medicines for safety. Clinicians are supported to supply, store, compound, manufacture, prescribe, dispense, administer, monitor and safely dispose of medicines. Information and decision support tools for medicines
Action 4.13 Safe and secure storage and distribution of medicines
Action 4.14 High-risk medicines
Action 4.15 Background to this standard Medicines are the most common treatment used in health care. Although appropriate use of medicines contributes to substantial improvements in health, medicines can also be associated with harm.1 Because they are so commonly used, medicines are associated with a higher incidence of errors and adverse events than other healthcare interventions. Some of these events are costly, in terms of morbidity, mortality and resources. Up to 50% are potentially avoidable.2 Scope of this standard The Medication Safety Standard addresses areas of medication management that have a known risk of error, often as a result of unsafe processes and variation in clinician practices. The Medication Safety Standard requires health service organisations to assess medication management and implement processes and practices that: Provide for sound governance for the safe and quality use of medicines Minimise the occurrence of medicine-related incidents and the potential for patient harm from medicines Ensure that competent clinicians safely prescribe, dispense and administer medicines, and monitor their effects Inform patients about their medicines and involve them in decision-making. Key links with other standards The Medication Safety Standard should be applied in conjunction with other NSQHS Standards, including the Clinical Governance Standard and the Partnering with Consumers Standard. 51 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
Synergies with other NSQHS Standards will also need to be identified. This will ensure that medication safety and quality systems, and policies and processes for medication management are integrated, to reduce duplication of effort. Medication management pathway Medication management involves prescribing, dispensing, administering and monitoring medicines. Medication management is complex and involves several different clinicians. Often referred to as the medication management pathway, it comprises multiple activities and three system processes to manage the safe and effective use of medicines for patients at each episode of care.3,4 Safe processes and practices are required for all activities in the medication management pathway. These activities include procuring, supplying, storing, compounding, manufacturing, prescribing, dispensing, administering and monitoring the effects of medicines. The consumer is the central focus of the medication management pathway. Health service organisations should apply the principles of partnering with consumers, health literacy and shared decision making when developing, reviewing and implementing processes or practices within the medication management pathway. The pathway provides a framework for: Identifying when there is potential for errors or risk of harm Responding with strategies to reduce the opportunity for error. To ensure safe and effective use of medicines within the health service organisation, identify opportunities for patient harm and implement strategies to prevent medicine-related errors. Steps taken early in the medication management pathway can prevent adverse events occurring later in the pathway. References 1. Roughead EE, Semple SJ, Rosenfeld E. Literature review: medication safety in Australia. Sydney: Australian Commission on Safety and Quality in Health Care; 2013. (accessed Sep 2017). 2. Roughead E, Semple S. Medication safety in acute care in Australia: where are we now? Part 1: a review of the extent and causes of medication problems 2002–2008. Aust New Zealand Health Policy 2009;6(1):18. 3. Stowasser D, Allinson YM, O’Leary K. Understanding the medicines management pathway. J Pharm Pract Res 2004;34(4):293–6. 4. Australian Pharmaceutical Advisory Council. Guiding principles to achieve continuity in medication management. Canberra: APAC; 2005. Accessed 23/10/2019: https://www.safetyandquality.gov.au/standards/nsqhs- standards/medication-safety-standard
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20.9 MMAS-8 and PREMS VCPS Patient information sheet
Dr Shannon Nott Rural Director of Medical Services Western NSW Local Health District Dubbo NSW AUSTRALIA T: +61 (2) 6378 6272 E: [email protected]
Participant Information Sheet Invitation You are invited to participate in a research study called Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
Who is doing this project? Project team: Shannon Nott, Ged Hawthorn, Brett Chambers, Mary Hoy, Chris Doran, Chris Oldmeadow, Jo-Anne Brien, Julaine Allan Organisations: Western NSW Health District, Far West Health District, Central QLD University, Hunter Medical Research Institute, University of Sydney What is the purpose of this study? We are conducting a research project to evaluate the provision of hospital pharmacy services (VCPS) via video link to patients at 8 hospitals in Western and Far West NSW LHDs. The aim of the virtual pharmacy is to improve medicine use for patients at hospitals where they do not have access to an onsite hospital pharmacist. What does this study involve? You may see a pharmacist via a video link where they will talk to you about your medications. If you see a pharmacist via a video link you will be asked to complete a short survey about how you manage your medications at home or for feedback on your experience with the virtual pharmacy service. This may be while you are in hospital or after you have gone home. Your feedback will help us review how care is delivered and improve it. Why have I been invited to participate in this study? You are eligible to participate in this study because you are admitted to a hospital where the virtual pharmacy service is operating.
Do I have to participate in this study? Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect the treatment you receive now or in the future. Whatever your decision, it will not affect your relationship with the staff caring for you. You can withdraw consent and stop participation at any time without giving reasons. How is this study being paid for? This project is funded by the NSW Ministry of Health Translational Research Grants Scheme. Are there any good things about being in the study? You will be provided a pharmacy service including advice on your medications that otherwise would not be available to you. This study aims to further our experience with pharmacy telehealth and may 53 Virtual Clinical Pharmacy Service: Research Protocol Version 2.0: 22 November 2019
benefit the community by developing recommendations for best practice. The study will also help Western NSW Local Health District and other health services evaluate and plan future virtual services including pharmacy telehealth. Are there any bad things about being in the project? This study will take up some of your time, but it won’t cost you anything or it is not anticipated to cause any problems. What will happen with the information collected during this project? All of the information that we have from the project will be stored in a safe place and we will look after it carefully. The pharmacist will document their interactions with you, such as your current medication list, in your hospital electronic health record as it is required for your care. For the surveys we will not ask any information that may identify you and all responses will be anonymous and strictly confidential. We may also develop a report and submit it to an academic journal for publication however information will be provided in such a way that you cannot be identified. Will anyone else know I was in the study? Any identifiable information that is collected about you in connection with this study will remain confidential. The people treating you in hospital and the research team will know whether or not you are participating in this study. While all effort will be made to maintain confidentiality due to shared patient rooms, we cannot absolutely guarantee this. What if I am not happy with the project or the people doing the project? This research has been approved by the Greater Western Area Human Research Ethics Committee. Anyone with any concerns or complaints may contact the Committee’s Executive Officer on (02) 6330 5948 or email [email protected] and quote reference 2019/ETH13355. Alternatively you may contact Shannon Nott (project supervisor) on (02) 6378 6272 or email [email protected]
This sheet is for you to keep.
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20.10 PREMS face to face pharmacy (control group) patient information sheet
Dr Shannon Nott Rural Director of Medical Services Western NSW Local Health District Dubbo NSW AUSTRALIA T: +61 (2) 6378 6272 E: [email protected]
Participant Information Sheet Invitation You are invited to participate in a research study called Realising the benefits of clinical pharmacy in the bush: The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities
Who is doing this project? Project team: Shannon Nott, Ged Hawthorn, Brett Chambers, Mary Hoy, Chris Doran, Chris Oldmeadow, Jo-Anne Brien, Julaine Allan Organisations: Western NSW Health District, Far West Health District, Central QLD University, Hunter Medical Research Institute, University of Sydney What is the purpose of this study? We are conducting a research project to evaluate the provision of hospital pharmacy services (VCPS) via video link to patients at 8 hospitals in Western and Far West NSW LHDs. The aim of the virtual pharmacy is to improve medicine use for patients at hospitals where they do not have access to an onsite hospital pharmacist. What does this study involve? You may see a pharmacist where they will talk to you about your medications. If you see a pharmacist you will be asked to complete a short survey while you are in hospital for feedback on your experience with the pharmacy service. Your feedback will help us review how care is delivered and improve it. Why have I been invited to participate in this study? You are eligible to participate in this study because you are admitted to a hospital participating as a control to help us compare face to face verses telehealth pharmacy.
Do I have to participate in this study? Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect the treatment you receive now or in the future. Whatever your decision, it will not affect your relationship with the staff caring for you. You can withdraw consent and stop participation at any time without giving reasons. How is this study being paid for? This project is funded by the NSW Ministry of Health Translational Research Grants Scheme. Are there any good things about being in the study? This study aims to further our experience with pharmacy telehealth and may benefit the community by developing recommendations for best practice. The study will also help Western NSW Local
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Health District and other health services evaluate and plan future virtual services including pharmacy telehealth. Are there any bad things about being in the project? This study will take up some of your time, but it won’t cost you anything or it is not anticipated to cause any problems. What will happen with the information collected during this project? All of the information that we have from the project will be stored in a safe place and we will look after it carefully. We will not ask any information that may identify you and all responses will be anonymous and strictly confidential. We may also develop a report and submit it to an academic journal for publication however information will be provided in such a way that you cannot be identified. Will anyone else know I was in the study? No identifiable information is collected about you in connection with this study, however the people treating you in hospital will know whether or not you are participating in this study. While all effort will be made to maintain confidentiality due to shared patient rooms, we cannot absolutely guarantee this. What if I am not happy with the project or the people doing the project? This research has been approved by the Greater Western Area Human Research Ethics Committee. Anyone with any concerns or complaints may contact the Committee’s Executive Officer on (02) 6330 5948 or email [email protected] and quote reference 2019/ETH13355. Alternatively you may contact Shannon Nott (project supervisor) on (02) 6378 6272 or email [email protected]
This sheet is for you to keep.
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