An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation

Autoři: Thomas A. Willis aff001;  Michelle Collinson aff002;  Liz Glidewell aff003;  Amanda J. Farrin aff002;  Michael Holland aff002;  David Meads aff001;  Claire Hulme aff004;  Duncan Petty aff005;  Sarah Alderson aff001;  Suzanne Hartley aff002;  Armando Vargas-Palacios aff001;  Paul Carder aff006;  Stella Johnson aff006;  Robbie Foy aff001
Působiště autorů: Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom aff001;  Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom aff002;  Department of Health Sciences, Hull York Medical School, University of York, York, United Kingdom aff003;  College of Medicine and Health, University of Exeter, Exeter, United Kingdom aff004;  School of Pharmacy and Medical Sciences, University of Bradford, Bradford, United Kingdom aff005;  West Yorkshire Research and Development, NHS Bradford Districts CCG, Bradford, United Kingdom aff006
Vyšlo v časopise: An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation. PLoS Med 17(2): e32767. doi:10.1371/journal.pmed.1003045
Kategorie: Research Article
doi: 10.1371/journal.pmed.1003045



In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.

Methods and findings

We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used ‘opt-out’ recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67–0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89–1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96–1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75–1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39–0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.


In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.

Trial registration

The study is registered with the ISRCTN registry (ISRCTN91989345).

Klíčová slova:

Atrial fibrillation – Blood pressure – Cost-effectiveness analysis – diabetes mellitus – HbA1c – Chronic kidney disease – NSAIDs – Primary care


1. Levine DM, Linder JA, Landon BE. The quality of outpatient care delivered to adults in the United States, 2002 to 2013. JAMA Intern Med. 2016;176(12): 1778–1790. doi: 10.1001/jamainternmed.2016.6217 27749962

2. Cooksey R. A review of UK health research funding. London: HMSO; 2006.

3. Baird B, Charles A, Honeyman M, Maguire D, Das P. Understanding pressures in general practice. London: The King’s Fund; 2016.

4. Hobbs FDR, Bankhead C, Mukhtar T, Stevens S, Perera-Salazar R, Holt T, et al. Clinical workload in UK primary care: a retrospective analysis of 100 million consultations in England, 2007–14. Lancet. 2016;387(10035): 2323–2330. doi: 10.1016/S0140-6736(16)00620-6 27059888

5. Rushforth B, Stokes T, Andrews E, Willis TA, McEachan R, Faulkner S, et al. Developing ‘high impact’ guideline-based quality indicators for UK primary care: a multi-stage consensus process. BMC Fam Pract. 2015;16(1): 156.

6. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8(6): iii–iv, 1–72. doi: 10.3310/hta8060 14960256

7. Willis TA, Rushforth B, West R, Faulkner S, Stokes T, Glidewell L, et al. Variations in achievement of evidence-based, high-impact quality indicators in general practice: an observational study. PLoS ONE. 2017;12(7): e0177949. doi: 10.1371/journal.pone.0177949 28704407

8. National Institute for Health and Care Excellence. Type 2 diabetes in adults: management. London: Royal College of Physicians; 2015.

9. Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, et al. Which drugs cause preventable admissions to hospital? A systematic review. Brit J Clin Pharmacol. 2007;63(2): 136–147.

10. The Blood Pressure Lowering Treatment Trialists’ Collaboration. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet. 2014;384(9943): 591–598. doi: 10.1016/S0140-6736(14)61212-5 25131978

11. National Institute for Health and Care Excellence. Atrial fibrillation: the management of atrial fibrillation. London: National Institute for Health and Care Excellence; 2014.

12. Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, et al. Audit and feedback: effects on professional practice and patient outcomes. Cochrane Database Syst Rev. 2012(6). Art. No.: CD000259. doi: 10.1002/14651858.CD000259.pub3 22696318

13. O’Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen J, Kristoffersen DT, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007(4). Art. No.: CD000409. doi: 10.1002/14651858.CD000409.pub2 17943742

14. Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009(3). Art.No.: CD001096. doi: 10.1002/14651858.CD001096.pub2 19588323

15. Lawton R, Heyhoe J, Louch G, Ingleson E, Glidewell L, Willis TA, et al. Using the Theoretical Domains Framework (TDF) to understand adherence to multiple evidence-based indicators in primary care: a qualitative study. Implement Sci. 2016;11(113).

16. Glidewell L, Willis TA, Petty D, Lawton R, McEachan RRC, Ingleson E, et al. To what extent can behaviour change techniques be identified within an adaptable implementation package for primary care? A prospective directed content analysis. Implement Sci. 2018;13(32).

17. Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003;12(1): 47–52. doi: 10.1136/qhc.12.1.47 12571345

18. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350: h2147. doi: 10.1136/bmj.h2147 25956159

19. Lord PA, Willis TA, Carder P, West RM, Foy R. Optimizing primary care research participation: a comparison of three recruitment methods in data-sharing studies. Fam Pract. 2016;33(2): 200–204. doi: 10.1093/fampra/cmw003 26921610

20. Willis TA, Hartley S, Glidewell L, Farrin AJ, Lawton R, McEachan RRC, et al. Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting ‘high impact’ clinical practice recommendations in general practice. Implement Sci. 2016;11(1): 1–11.

21. Doran T, Fullwood C, Gravelle H, Reeves D, Kontopantelis E, Hiroeh U, et al. Pay-for-performance programs in family practices in the United Kingdom. N Engl J Med. 2006;355(4): 375–384. doi: 10.1056/NEJMsa055505 16870916

22. Hayes AJ, Leal J, Gray AM, Holman RR, Clarke PM. UKPDS Outcomes Model 2: a new version of a model to simulate lifetime health outcomes of patients with type 2 diabetes mellitus using data from the 30 year United Kingdom Prospective Diabetes Study: UKPDS 82. Diabetologia. 2013;56(9): 1925–1933. doi: 10.1007/s00125-013-2940-y 23793713

23. Lovibond K, Jowett S, Barton P, Caulfield M, Heneghan C, Hobbs FD, et al. Cost-effectiveness of options for the diagnosis of high blood pressure in primary care: a modelling study. Lancet. 2011;378(9798): 1219–1230. doi: 10.1016/S0140-6736(11)61184-7 21868086

24. Department for Communities and Local Government. English indices of deprivation 2015 [Cited 2019 Nov 12].

25. Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, et al. Tailored interventions to address determinants of practice. Cochrane Database Syst Rev. 2015(4). Art. No.: CD005470. doi: 10.1002/14651858.CD005470.pub3 25923419

26. Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Cresswell K, Eden M, et al. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet. 2012;379(9823): 1310–1319. doi: 10.1016/S0140-6736(11)61817-5 22357106

27. Dreischulte T, Donnan P, Grant A, Hapca A, McCowan C, Guthrie B. Safer prescribing—a trial of education, informatics, and financial incentives. N Engl J Med. 2016;374(11): 1053–1064. doi: 10.1056/NEJMsa1508955 26981935

28. Guthrie B, Kavanagh K, Robertson C, Barnett K, Treweek S, Petrie D, et al. Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial. BMJ. 2016;354: i4079. doi: 10.1136/bmj.i4079 27540041

29. Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012;379(9833): 2252–2261. doi: 10.1016/S0140-6736(12)60480-2 22683130

30. McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014;67(3): 267–277. doi: 10.1016/j.jclinepi.2013.08.015 24275499

31. Berwick DM. The science of improvement. JAMA. 2008;299(10): 1182–1184. doi: 10.1001/jama.299.10.1182 18334694

32. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337: a1655. doi: 10.1136/bmj.a1655 18824488

33. Grol R, Dalhuijsen J, Thomas S, Veld C, Rutten G, Mokkink H. Attributes of clinical guidelines that influence use of guidelines in general practice: observational study. BMJ. 1998;317(7162): 858–861. doi: 10.1136/bmj.317.7162.858 9748183

34. Hallsworth M, Chadborn T, Sallis A, Sanders M, Berry D, Greaves F, et al. Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial. Lancet. 2016;387(10029): 1743–1752. doi: 10.1016/S0140-6736(16)00215-4 26898856

35. Foy R, Leaman B, McCrorie C, Petty D, House A, Bennett M, et al. Prescribed opioids in primary care: cross-sectional and longitudinal analyses of influence of patient and practice characteristics. BMJ Open. 2016;6(5): e010276. doi: 10.1136/bmjopen-2015-010276 27178970

36. Holt TA, Dalton A, Marshall T, Fay M, Qureshi N, Kirkpatrick S, et al. Automated software system to promote anticoagulation and reduce stroke risk: cluster-randomized controlled trial. Stroke. 2017;48(3): 787–790. doi: 10.1161/STROKEAHA.116.015468 28119433

Článek vyšel v časopise

PLOS Medicine

2020 Číslo 2

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