BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-015281 on 10 March 2017. Downloaded from Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: Case-study evaluation of adoption and maintenance of a complex intervention to reduce high-risk primary care prescribing For peer review only Journal: BMJ Open Manuscript ID bmjopen-2016-015281 Article Type: Research Date Submitted by the Author: 25-Nov-2016 Complete List of Authors: Grant, Aileen; University of Stirling, Health Sciences & Sport Dreischulte, Tobias; University of Dundee, Population Health Sciences Guthrie, Bruce; University of Dundee, Population Health Sciences Division, Medical Research Institute <b>Primary Subject General practice / Family practice Heading</b>: Health services research, Evidence based practice, Health informatics, Secondary Subject Heading: Qualitative research PRIMARY CARE, Prescribing, General Practice, Quality and Safety, Keywords: Randomised Controlled Trials, Process Evaluation http://bmjopen.bmj.com/ on October 3, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 55 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-015281 on 10 March 2017. Downloaded from 1 2 3 4 1 Process evaluation of the Data-driven Quality Improvement in Primary 5 6 2 Care (DQIP) trial: Case-study evaluation of adoption and maintenance of a 7 8 3 complex intervention to reduce high-risk primary care prescribing 9 4 10 11 12 5 13 14 6 Aileen Grant PhD, Research Fellow1 15 For peer review only 16 2 3 17 7 Tobias Dreischulte PhD, Lead Pharmacist Research and Development 18 19 8 Bruce Guthrie PhD, Professor of Primary Care Medicine3 20 21 9 22 23 24 10 Affiliations: 25 26 11 1. School of Health Sciences & Sport, University of Stirling, Stirling, UK 27 28 12 2. Medicines Governance Unit, NHS Tayside, Dundee, UK 29 13 3. Population Health Sciences Division, Medical Research Institute, University of Dundee, 30 31 14 Dundee, UK 32 33 15 Corresponding author 34 http://bmjopen.bmj.com/ 35 36 16 Aileen Grant: [email protected] 37 38 39 17 Keywords 40 41 18 General practice; family practice; prescribing; quality and safety; randomised controlled trials; 42 on October 3, 2021 by guest. Protected copyright. 43 19 process evaluation 44 45 20 46 47 21 Word count: 4,976 48 49 50 51 52 53 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 55 BMJ Open: first published as 10.1136/bmjopen-2016-015281 on 10 March 2017. Downloaded from 1 2 3 22 Abstract 4 5 23 Objective: Explore how different practices responded to the DQIP intervention in terms of their 6 7 8 24 adoption of the work, reorganisation to deliver the intended change in care to patients, and whether 9 10 25 implementation was sustained over time. 11 12 13 26 Design: Mixed methods parallel process evaluation of a cluster trial, reporting the comparative case 14 15 27 study of purposivelyFor selected peer practices. review only 16 17 18 28 Setting: Ten (30%) primary care practices participating in the trial. 19 20 21 29 Results: Four practices were sampled because they had large rapid reductions in targeted 22 23 30 prescribing. They all had internal agreement that the topic mattered, made early plans to implement 24 25 31 including assigning responsibility for work, and regularly evaluated progress. However, how they 26 27 32 internally organised the work varied. Six practices were sampled because they had initial 28 29 33 implementation failure. Implementation failure occurred at different stages depending on practice 30 31 32 34 context, including internal disagreement about whether the work was worthwhile, and intention but 33 35 lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice 34 http://bmjopen.bmj.com/ 35 36 36 context was not fixed, and most practices with initial failed implementation adapted to deliver at 37 38 37 least some elements. All interviewed participants valued the intervention because it was an 39 40 38 innovative way to address on an important aspect of safety (although one of the non-interviewed 41 42 39 GPs in one practice disagreed with this). Participants felt that reviewing existing prescribing did on October 3, 2021 by guest. Protected copyright. 43 44 45 40 influence their future initiation of targeted drugs, but raised concerns about sustainability. 46 47 48 41 Conclusions: Variation in implementation and effectiveness was associated with differences in how 49 50 42 practices valued, engaged with, and sustained the work required. Initial implementation failure 51 52 43 varied with practice context, but was not static, with most practices at least partially implementing 53 54 44 by the end of the trial. Practices organised their delivery of changed care to patients in ways which 55 56 45 suited their context, emphasising the importance of flexibility in any future widespread 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 55 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-015281 on 10 March 2017. Downloaded from 1 2 3 46 implementation. 4 5 6 47 Trial registration: ClinicalTrials.gov number, NCT01425502 7 8 9 48 Strengths and limitations of the study 10 11 49 • This is a comprehensive, pre-planned, process evaluation which includes a third of all 12 50 practices which participated in the DQIP stepped-wedge cluster-randomised trial. 13 14 51 • The evaluation sampled four practices which rapidly implemented the intervention and all 15 For peer review only 16 52 six practices which failed to implement the intervention to some degree. 17 53 • A strength of the study is the use of both qualitative data from interviews and observational 18 19 54 field notes, and quantitative data about key trial processes and practice-level effectiveness 20 21 55 to examine implementation in detail. 22 56 • A limitation is that we did not collect any data from practices prior to them receiving the 23 24 57 intervention. 25 26 58 27 Key words: 28 29 59 Complex intervention, process evaluation, general practice, primary care, prescribing practice. 30 31 60 32 33 34 61 Background http://bmjopen.bmj.com/ 35 36 62 High-risk prescribing in primary care is a major concern for health care systems internationally. 37 38 63 Between 2-4% of emergency hospital admissions are caused by preventable adverse drug events,[1, 39 40 64 2] at significant cost to healthcare systems.[3][4] A large proportion of these admissions are caused 41 42 65 by commonly prescribed drugs, with non-steroidal anti-inflammatory drugs (NSAIDs) and on October 3, 2021 by guest. Protected copyright. 43 44 66 antiplatelets being frequently implicated, causing gastrointestinal, cardiovascular and renal adverse 45 46 67 events.[5-7] 47 48 49 68 The DQIP intervention was systematically developed and optimised[8-10] and comprised three 50 51 52 69 intervention components: (a) professional education about the risks of NSAIDs and antiplatelets via 53 54 70 an outreach visit by a pharmacist; (b) financial incentives to review patients at the highest risk of 55 56 71 NSAID and antiplatelet ADEs, split into a participation fee of £350 and £15 per patient reviewed; and 57 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 55 BMJ Open: first published as 10.1136/bmjopen-2016-015281 on 10 March 2017. Downloaded from 1 2 3 72 (c) access to a web-based IT tool to identify such patients and support structured review. The 4 5 73 intervention was evaluated in a pragmatic stepped-wedge cluster-randomised controlled trial[11] in 6 7 74 33 practices from one Scottish health board, where all participating practices received the 8 9 75 intervention but were randomised to one of ten different start dates.[8] Across all practices, 10 11 12 76 targeted high-risk prescribing fell from 3.7% immediately before to 2.2% at the end of the 13 14 77 intervention period (adjusted OR 0.63 [95%CI 0.57-0.68], p<0.0001). The intervention only 15 For peer review only 16 78 incentivised review of ongoing high-risk prescribing, but led to reductions in both ongoing (adjusted 17 18 79 OR 0.60, 95%CI 0.53-0.67) and ‘new’ high-risk prescribing (adjusted OR 0.77, 95%CI 0.68-0.87). 19 20 80 Notably reductions in high-risk prescribing were sustained in the year after financial incentives 21 22 81 stopped. In addition, there were significant reductions in emergency hospital admissions with 23 24 25 82 gastrointestinal ulcer or bleeding (RR 0.66, 95%CI 0.51-0.86), and heart failure (RR 0.73, 95%CI 0.56- 26 27 83 0.95).[12] 28 29 30 84 Alongside the main trial, we designed a mixed-methods process evaluation, [13, 14] based on a 31 32 85 cluster-randomised trial process-evaluation framework which we developed.[15] Our framework 33 34 86 emphasises the importance of considering two levels of intervention delivery and response that http://bmjopen.bmj.com/ 35 36 87 often characterise cluster-randomised trials of behaviour change interventions (although their 37 38 88 importance will depend on intervention design). The first is the intervention that is delivered to 39 40 89 clusters, which respond by adopting (or not) the intervention and integrating it with existing work. 41 42 on October 3, 2021 by guest. Protected copyright.