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

Laura J Damschroder^{1

2}, Tannaz Moin^{3

4

5}, Santanu K Datta^{6

7}, Caitlin M Reardon⁸, Nanette Steinle^{9

10}, Jane Weinreb^{11

12}, Charles J Billington^{13

14}, Matt L Maciejewski^{15

16}, William S Yancy Jr^{17

18}, Maria Hughes¹⁹, Fatima Makki²⁰, Caroline R Richardson^{21

22

23}

Affiliations

¹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. laura.damschroder@va.gov.
² VA Diabetes QUERI, Ann Arbor, MI, USA. laura.damschroder@va.gov.
³ VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁴ David Geffen School of Medicine, University of California, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁵ Greater Los Angeles VA Health Services Research and Development (HSR & D) Center for Healthcare Innovation, Implementation and Policy, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁶ Durham VA Medical Center, Durham, NC, USA. santanu.datta@duke.edu.
⁷ Duke University School of Medicine, Durham, NC, USA. santanu.datta@duke.edu.
⁸ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caitlin.reardon@va.gov.
⁹ Baltimore VA Medical Center, Baltimore, MD, USA. nanette.steinle@va.gov.
¹⁰ University of Maryland School of Medicine, Baltimore, MD, USA. nanette.steinle@va.gov.
¹¹ VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. jane.weinreb@va.gov.
¹² David Geffen School of Medicine, University of California, Los Angeles, CA, USA. jane.weinreb@va.gov.
¹³ Minneapolis VA Healthcare System, Minneapolis, MN, USA. billi005@umn.edu.
¹⁴ University of Minnesota Medical Center, Minneapolis, MN, USA. billi005@umn.edu.
¹⁵ Durham VA Medical Center, Durham, NC, USA. matthew.maciejewski@va.gov.
¹⁶ Duke University School of Medicine, Durham, NC, USA. matthew.maciejewski@va.gov.
¹⁷ Durham VA Medical Center, Durham, NC, USA. will.yancy@duke.edu.
¹⁸ Duke University School of Medicine, Durham, NC, USA. will.yancy@duke.edu.
¹⁹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. maria.hughes2@va.gov.
²⁰ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. fatima.makki@va.gov.
²¹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caroli@med.umich.edu.
²² VA Diabetes QUERI, Ann Arbor, MI, USA. caroli@med.umich.edu.
²³ Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. caroli@med.umich.edu.

PMID: 25962598
PMCID: PMC4429938
DOI: 10.1186/s13012-015-0250-0

Clinical Trial

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

Laura J Damschroder et al. Implement Sci. 2015.

. 2015 May 12:10:68.

doi: 10.1186/s13012-015-0250-0.

Authors

Affiliations

¹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. laura.damschroder@va.gov.
² VA Diabetes QUERI, Ann Arbor, MI, USA. laura.damschroder@va.gov.
³ VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁴ David Geffen School of Medicine, University of California, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁵ Greater Los Angeles VA Health Services Research and Development (HSR & D) Center for Healthcare Innovation, Implementation and Policy, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.
⁶ Durham VA Medical Center, Durham, NC, USA. santanu.datta@duke.edu.
⁷ Duke University School of Medicine, Durham, NC, USA. santanu.datta@duke.edu.
⁸ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caitlin.reardon@va.gov.
⁹ Baltimore VA Medical Center, Baltimore, MD, USA. nanette.steinle@va.gov.
¹⁰ University of Maryland School of Medicine, Baltimore, MD, USA. nanette.steinle@va.gov.
¹¹ VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. jane.weinreb@va.gov.
¹² David Geffen School of Medicine, University of California, Los Angeles, CA, USA. jane.weinreb@va.gov.
¹³ Minneapolis VA Healthcare System, Minneapolis, MN, USA. billi005@umn.edu.
¹⁴ University of Minnesota Medical Center, Minneapolis, MN, USA. billi005@umn.edu.
¹⁵ Durham VA Medical Center, Durham, NC, USA. matthew.maciejewski@va.gov.
¹⁶ Duke University School of Medicine, Durham, NC, USA. matthew.maciejewski@va.gov.
¹⁷ Durham VA Medical Center, Durham, NC, USA. will.yancy@duke.edu.
¹⁸ Duke University School of Medicine, Durham, NC, USA. will.yancy@duke.edu.
¹⁹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. maria.hughes2@va.gov.
²⁰ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. fatima.makki@va.gov.
²¹ Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caroli@med.umich.edu.
²² VA Diabetes QUERI, Ann Arbor, MI, USA. caroli@med.umich.edu.
²³ Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. caroli@med.umich.edu.

PMID: 25962598
PMCID: PMC4429938
DOI: 10.1186/s13012-015-0250-0

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.

PubMed Disclaimer

Figures

**Figure 1**
VA DPP strategic framework for implementation.

**Figure 2**
Formative evaluation framework: integration of RE-AIM and the CFIR.

See this image and copyright information in PMC

References

1. Diabetes Prevention Program Research Group, Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403. doi:10.1056/NEJMoa012512. - PMC - PubMed
1. Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, et al. The Finnish Diabetes Prevention Study (DPS): lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003;26(12):3230–6. doi: 10.2337/diacare.26.12.3230. - DOI - PubMed
1. Li G, Zhang P, Wang J, Gregg EW, Yang W, Gong Q, et al. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing diabetes prevention study: a 20-year follow-up study. Lancet. 2008;371(9626):1783–9. doi: 10.1016/S0140-6736(08)60766-7. - DOI - PubMed
1. Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V, et al. The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1) Diabetologia. 2006;49(2):289–97. doi: 10.1007/s00125-005-0097-z. - DOI - PubMed
1. Diabetes Prevention Program Research Group, Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, et al. 10-year follow-up of diabetes incidence and weight loss in the diabetes prevention program outcomes study. Lancet. 2009;374(9702):1677–86. doi:10.1016/S0140-6736 (09) 61457-4. - PMC - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical