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Open Access 01-12-2015 | Study protocol

Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial

Authors: Laura J Damschroder, Tannaz Moin, Santanu K Datta, Caitlin M Reardon, Nanette Steinle, Jane Weinreb, Charles J Billington, Matt L Maciejewski, William S Yancy Jr., Maria Hughes, Fatima Makki, Caroline R Richardson

Published in: Implementation Science | Issue 1/2015

Abstract

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.

Available only for authorised users

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Title: Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial
Authors: Laura J Damschroder
Tannaz Moin
Santanu K Datta
Caitlin M Reardon
Nanette Steinle
Jane Weinreb
Charles J Billington
Matt L Maciejewski
William S Yancy Jr.
Maria Hughes
Fatima Makki
Caroline R Richardson
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI: https://doi.org/10.1186/s13012-015-0250-0

At a glance: The STEP trials

Springer Medicine

Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial

Abstract

Background

Methods/Design

Discussion

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

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