An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation
Open Access
- 28 February 2020
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLoS Medicine
- Vol. 17 (2), e1003045
- https://doi.org/10.1371/journal.pmed.1003045
Abstract
Background 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 pound per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary end-points (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. Conclusions 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.Keywords
Funding Information
- Programme Grants for Applied Research (RP-PG-1209-10040)
This publication has 32 references indexed in Scilit:
- 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 82Diabetologia, 2013
- Audit and feedback: effects on professional practice and healthcare outcomesCochrane Database of Systematic Reviews, 2012
- The effects of on-screen, point of care computer reminders on processes and outcomes of careCochrane Database of Systematic Reviews, 2009
- Developing and evaluating complex interventions: the new Medical Research Council guidanceBMJ, 2008
- The Science of ImprovementJAMA, 2008
- Educational outreach visits: effects on professional practice and health care outcomesCochrane Database of Systematic Reviews, 2007
- Pay-for-Performance Programs in Family Practices in the United KingdomNew England Journal of Medicine, 2006
- Which drugs cause preventable admissions to hospital? A systematic reviewBritish Journal of Clinical Pharmacology, 2006
- Research designs for studies evaluating the effectiveness of change and improvement strategiesQuality and Safety in Health Care, 2003
- Attributes of clinical guidelines that influence use of guidelines in general practice: observational studyBMJ, 1998