Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation

Abstract

ObjectivesDuring 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.DesignMixed-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.SettingThirty-three UK general practices in three areas.ParticipantsThe 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.ResultsStaff 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.ConclusionsImplementation 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

Patient-centred innovation for multimorbidity care: a mixed-methods, randomised trial and qualitative study of the patients’ experience

“…Intervention failure was not a problem here as it has been with other interventions. 19 Co-creation of the intervention, as in Mercer et al , 15 or provider creation, as in the present study, appear to avoid implementation lapses.…”

“…The current study advances on previous work by testing an intervention that should enhance everyday practice. This intervention should overcome the problem of implementation lapses found in other studies, 19 because it was provider created, which goes even further than a co-created intervention. 15 The lack of impact on outcomes for patients with an income of <C$50 000 contrasts with Mercer et al ’s 15 multifaceted intervention, which was effective for patients who were considered to be socioeconomically deprived; they focused on self-management support, more face-to-face time with patients, and continuity of care — aspects of care that could enhance follow-up to the TIP programme.…”

“…Also piloted, provider-created interventions could be trialled to diminish the difficulties of implementation experienced by some researchers. 19 …”

Facilitators and “deal breakers”: a mixed methods study investigating implementation of the Goal setting and action planning (G-AP) framework in community rehabilitation teams

“…Using Normalisation Process Theory enabled us to gain important new insights on G-AP implementation which will inform the development of the G-AP training and implementation strategies, thus optimising the chances of future implementation success. Distinguishing between implementation failure and intervention failure is an important aspect of clinical practice and clinical trials [57]. We believe that this study is essential preparatory work to increase the adoption of G-AP in clinical settings and reduce the chances of implementation failure in our planned evaluation.…”

Self-management program versus usual care for community-dwelling older adults with multimorbidity: A pragmatic randomized controlled trial in Ontario, Canada

“…Moreover, the 3D trial process evaluation identified inadequate intervention fidelity and provider training on patient engagement as factors contributing to their modest results. 22 A 2018 scoping review further contributed by identifying the patient/professional/organizational elements (e.g., face-to-face clinical assessments, tailored interventions, provider education/meetings) that were included in effective multimorbidity interventions. 23 Since all interventions in the scoping review were complex and involved between four and eight elements, it was not possible to isolate one component to link to the success of the intervention.…”