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Abstract
Objectives During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.
Design Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.
Setting Thirty-three UK general practices in three areas.
Participants The trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.
Results Staff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from ‘tick-box’ to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
Conclusions Implementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.
Trial registration number ISRCTN06180958
- process evaluation
- implementation fidelity
- intervention failure
- implementation failure
- multimorbidity
- primary care
- patient-centred
- null trial
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Footnotes
Twitter @Jcindymann
Contributors CM, ARGS and BG designed the process evaluation. CS led the design of the 3D intervention and the randomised trial. CM collected and analysed the qualitative data with input from ARGS, LW and BG and led the analysis and write-up of the results presented in this paper. ARGS, BG and CS critically revised the manuscript. KC helped to design the template, analysed the quantitative data it recorded and helped to collect administrative survey data. M-SM contributed to the design of the process evaluation and facilitated data collection in the role of trial manager. All authors discussed findings, commented on the paper and approved the final version.
Funding This project was funded by the National Institute for Health Research Health Services and Delivery Research Programme (project number 12/130/15).
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The trial and process evaluation were approved by the South-West England NHS Research Ethics Committee (14/SW/0011)
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data relevant to the study are included in the article or uploaded as online supplementary information.Some qualitative data are subject to restricted access and may be available only on application to the author