Background: The Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10-20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective. Methods/Design: This partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE! program. Mediation analyses will be conducted to identify whether program design differences impact outcomes. Discussion: Findings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population.
Bibliographical noteFunding Information:
aQI: quality initiative funded by the National Center for Health Promotion and Disease Prevention (NCP). bSDP: Service Directed Project funded by the VA Quality Enhancement Research Initiative (QUERI) program; 2 year grant (12–549). cIRB: Institutional Review Boards are located at the three sites implementing the VA DPP, the research coordinating center, and the site conducting the cost analyses. dRRP: Rapid Response Project funded by the VA QUERI program; 1 year grant (12–440).
The VA DPP has been deemed a clinical quality improvement (QI) initiative. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Because of the extremely short timeline, the research coordinating center submitted two separate research proposals, which are detailed in this protocol. Each research proposal was reviewed by a national peer review panel. The first proposal was submitted as part of the Quality Enhancement Research Initiative (QUERI) Rapid Response Project (RRP) program, which funds 1-year studies. This grant will enable the research coordinating center to collect baseline data as the VA DPP begins. The research coordinating center then submitted a QUERI Service Directed Project (SDP), which funds 2-year studies. This grant will enable the research coordinating center to collect and analyze follow-up data. Table 3 details the different funding sources and institutional review board (IRB) approvals for evaluation activities.
This work was funded by the Veteran Affairs (VA) Quality Enhancement Research Initiative (QUERI) program through two research grants (RRP 12-440 and SDP 12-549) and clinical quality improvement funding (XVA 41-048). Dr. Moin received support from the VA Office of Academic Affiliations through the VA Health Services Research and Development AdvancedFellowship Program (TPM65-010), VA Greater Los Angeles, from 2011-2014. We want to thank our partners at NCP, led by Dr. Linda Kinsinger, without whom this complex multi-component study could not have happened.
- Diabetes prevention
- Pragmatic study design