Adaptation and Implementation of the Invested in Diabetes Study

DENNIS GURFINKEL
Sr. PRA, ACCORDS

Diabetes group visits are historically challenging to implement in primary care. Pragmatic trials optimally use existing staff to deliver the intervention and allow flexibility in adherence and delivery.

1. To describe use of the Replicating Effective Programs for adapting and implementing an evidence-based intervention for use in real-world care settings.
2. To describe methods for establishing fidelity and adaptations to a study protocol to ensure rigor and feasibility of the conduct of a pragmatic trial.

The Invested in Diabetes study is an ongoing pragmatic cluster randomized comparative effectiveness trial testing two group visit models for delivering the Targeted Training in Illness Management (TTIM) curriculum for diabetes in primary care.1 In one model, TTIM is delivered by a health educator, with set topic order. In the other model, TTIM is delivered by a multidisciplinary care team, with topic order selected by patients. Practices are supported using the Replicating Effective Programs (REP) implementation framework plus intensive practice facilitation.2 Patient and practice stakeholder input was used to adapted TTIM curriculum and the study protocol and outcome measures. Dedicated research staff were used to help practices implement the project and collect outcomes data (patient-reported outcomes and Electronic Health Record data). Finally, the study team observes one session per practice/quarter to monitor fidelity to the TTIM curriculum and study core elements, documenting adaptations to content or delivery.

Study team members rated the pragmatic design of the study protocol according to the PRECIS-2 guidelines3 (Figure 1). Core elements of the study were identified and described to ensure fidelity. Stakeholder-led adaptations of the protocol outside of core elements were identified pre-implementation, including 6 two-hour sessions instead of 12 one-hour sessions and streamlining patient-reported outcomes to those with clinical utility and patient preference. Twelve in-person and virtual trainings have been conducted to date; trainings have progressively highlighted importance of skill building activities for SMA facilitators. Around 80 practice coaching sessions have been done to help practices start and sustain their group visits. Practices delivered test data extracts in summer 2019; data quality assessments revealed variability in accuracy and completeness. Thirteen months into the 24-month implementation period, 86 cohorts have gone live with 613 out of the goal of 1440 patients enrolled in group visits. Ongoing practice support is maintained through dedicated practice coaches to help troubleshoot issues and maintain fidelity to the study protocol.

To retain rigor in the study design, the REP framework allowed for adaptation to context while establishing core elements that must remain in place for hypothesis testing. The Invested in Diabetes study implementation processes help to ensure rigor of the design as well as feasibility of delivery in real-world primary care practices.