Deprescribing Anticholinergic and Sedative Medicines: Protocol for a Feasibility Trial (DEFEAT- Polypharmacy) in Residential Aged Care Facilities
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Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2016-013800 on 16 April 2017. Downloaded from Deprescribing anticholinergic and sedative medicines: protocol for a Feasibility Trial (DEFEAT- polypharmacy) in residential aged care facilities Nagham Ailabouni,1 Dee Mangin,2 Prasad S Nishtala1 To cite: Ailabouni N, ABSTRACT Strengths and limitations of this study Mangin D, Nishtala PS. Introduction: Targeted deprescribing of Deprescribing anticholinergic anticholinergic and sedative medicines can lead to ▪ and sedative medicines: Using a quantitative measure (ie, the Drug Burden positive health outcomes in older people; as they have protocol for a Feasibility Trial Index) will help to determine the effect of depre- (DEFEAT-polypharmacy) in been associated with cognitive and physical scribing anticholinergic and sedative medicines. residential aged care facilities. functioning decline. This study will examine whether ▪ A pharmacist conducting in-depth medicine BMJ Open 2017;7:e013800. the proposed intervention is feasible at reducing the reviews could help to alleviate time constraints doi:10.1136/bmjopen-2016- prescription of anticholinergic and sedative medicines often faced by general practitioners in the resi- 013800 in older people. dential care setting. Methods and analysis: The Standard Protocol ▪ Six months may not be adequate to fully investi- ▸ Prepublication history and Items: Recommendations for Interventional trials gate the clinical effects of deprescribing. additional material is (SPIRIT checklist) was used to develop and report the available. To view please visit protocol. Single group (precomparison and the journal (http://dx.doi.org/ postcomparison) feasibility study design. 10.1136/bmjopen-2016- Study population: 3 residential care homes have INTRODUCTION 013800). been recruited. Deprescribing, the process of safely reducing http://bmjopen.bmj.com/ Intervention: This will involve a New Zealand or discontinuing unnecessary or harmful Received 8 August 2016 registered pharmacist using peer-reviewed medicines, has the potential to decrease Revised 26 January 2017 deprescribing guidelines, to recommend to general polypharmacy, reduce inappropriate medi- Accepted 17 February 2017 practitioners (GPs), sedative and anticholinergic cine use and improve health outcomes.12 medicines that can be deprescribed. The cumulative Two recent studies have shown that frail use of anticholinergic and sedative medicines for each older people can have their medicines safely participant will be quantified, using the Drug Burden Index (DBI). discontinued without any detrimental effects to their health.34A non-randomised con- Outcomes: The primary outcome will be the change on September 24, 2021 by guest. Protected copyright. in the participants’ DBI total and DBI PRN 3 and trolled study (n=119) carried out in six rest 6 months after implementing the deprescribing homes, showed a decreased prescription of intervention. Secondary outcomes will include the 2.8 medicines per patient that led to lower number of recommendations taken up by the GP, annual acute hospital admissions (12% in participants’ cognitive functioning, depression, quality the study group vs 30% in the control group, 1School of Pharmacy, of life, activities of daily living and number of falls. p<0.002); and decreased 1-year mortality University of Otago, Dunedin, Data collection points: Participants’ demographic rates (21% in the study group vs 45% in the New Zealand and clinical data will be collected at the time of control group, p<0.001).4 Improvement of 2University of Otago, enrolment, along with the DBI. Outcome measures will cognition,3 reduction of falls by up to 66%5 Christchurch and David ’ be collected at the time of enrolment, 3 and 6 months and a decrease of hip fractures by up to Braley Nancy Gordon, Chair postenrolment. in Family Medicine, McMaster 10%, were some of the benefits noted when Ethics and dissemination: Ethics approval has been University, Hamilton, Ontario, benzodiazepines and other psychotropic Canada granted by the Human Disability and Ethics Committee. 6 Ethical approval number (16/NTA/61). medicines were reduced or discontinued. Correspondence to Deprescribing also results in improved Trial registration number: Pre-results; 7 Dr Prasad S Nishtala; ACTRN12616000721404. medication adherence and reduced costs. [email protected] An Australian study projected that if the Ailabouni N, et al. BMJ Open 2017;7:e013800. doi:10.1136/bmjopen-2016-013800 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2016-013800 on 16 April 2017. Downloaded from average number of medications taken per person could Participant characteristics be reduced by one; this would result in an annual cost- Inclusion criteria: saving of $463 million dollars.8 Deprescribing has been 1. Age ≥65 years, shown to produce positive health outcomes for older 2. DBI>0.5, – people.3 6 However, the best approach to implement this 3. Prescribed at least one anticholinergic medication or intervention is not yet clear. This study therefore aims to sedative medicine. Table 1 lists all the target medi- test the feasibility of an intervention to carry out depre- cines that will be considered for deprescribing, along scribing of a targeted medicine group in older people with their corresponding Anatomical Therapeutic living in the residential care setting in New Zealand. A Classification (ATC) code. This list was adapted to suit targeted intervention of deprescribing medicines with New Zealand medicines, from the sedative and anti- anticholinergic and sedative effects will be conducted. cholinergic DBI medicines listed by Hilmer et al.17 In The fundamental aspect of this study is a pharmacist-led addition to this, a medicine will be considered as an intervention that uses a collaborative patient-centred anticholinergic medicine if it is clearly described as approach involving the residents and general practi- an anticholinergic medicine in the medicine informa- tioners (GPs), and aims to implement deprescribing tion. Similarly, a medicine will be considered as a recommendations supported by evidence-based tools. ‘sedative’ if it causes considerable drowsiness and sed- Anticholinergic and sedative medicines commonly ation. This group of medicines will encompass anti- – prescribed in older people9 11 are associated with psychotics, antidepressants and benzodiazepines or impairments in cognitive and physical functioning.12 13 non-benzodiazepine hypnotics. The Drug Burden Index (DBI) tool will be used to Exclusion criteria: quantify each participant’s prescription of anticholiner- 1. Limited life expectancy: resident is receiving pallia- gic and sedative medicines. The DBI is a linear, additive tive care or their life expectancy ≤3 months based on pharmacological model that uses both pharmacokinetic the Holmes life expectancy calculator.18 and pharmacodynamic principles to calculate an indivi- 2. Residents admitted for hospice care (short duration dual’s total exposure to anticholinergic and sedative of stay of <4 weeks). medicines.14 The association between increasing DBI and impaired function has been demonstrated in a Recruitment and consent cross-sectional analysis of two populations of older The RACF’s Medi-Map electronic prescribing computer people in the USA,15 in older Australian men16 and lon- system will be used to screen for all residents who fulfil gitudinally in community-dwelling older people in the the study’s inclusion and exclusion criteria as outlined USA.17 Hilmer et al14 showed that each additional unit above. Of these potential participants, the RACFs’ care- of DBI had a negative effect on the physical function of giver(s) or nurse(s) will determine which eligible poten- http://bmjopen.bmj.com/ older people similar to that of three additional physical tial participants are cognitively able to give their own comorbidities. In planning a full randomised controlled consent, and those potential participants who would not trial, it is appropriate to examine the feasibility of imple- be able to provide their own consent. To determine this, menting an intervention to assess whether it can reduce the nurses will use the InterRAI-Long Term Care this focused drug burden among older people living in Facilities (interRAI-LTCF) cognitive performance scale residential aged care. routinely applied to all residents (the pharmacist would The Standard Protocol Items: Recommendations for not be able to gain access to the residents’ medical elec- Interventional trials (SPIRIT checklist) was followed in tronic records before consent). The pharmacist will on September 24, 2021 by guest. Protected copyright. designing the study protocol (see online supplementary provide potential participants who are able to provide appendix 1). their own consent, the participant information sheet and consent form detailed in online supplementary appendix 2. Residents will be encouraged to consult and METHODS AND ANALYSIS discuss participating in the study with their family, Aims before consenting to take part. We hypothesise that the burden of anticholinergic and For potential participants with cognitive impairment sedative medicines can be reduced in a residential who are deemed by residential care staff to be unable to aged care setting using a collaborative, pharmacist-led, provide their own permission to take part in the study; evidence-supported intervention. the pharmacist and principal investigator (PI) will send a participation information sheet and declaration form Study