title: Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial.
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
  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!
  
  
  METHODS
  Mediation analyses will be conducted to identify whether program design differences impact outcomes.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. laura.damschroder@va.gov.|VA Diabetes QUERI, Ann Arbor, MI, USA. laura.damschroder@va.gov.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Damschroder
authors.affiliation: VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.|David Geffen School of Medicine, University of California, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.|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.
authors.forename: Tannaz
authors.initials: T
authors.lastname: Moin
authors.affiliation: Durham VA Medical Center, Durham, NC, USA. santanu.datta@duke.edu.|Duke University School of Medicine, Durham, NC, USA. santanu.datta@duke.edu.
authors.forename: Santanu K
authors.initials: SK
authors.lastname: Datta
authors.affiliation: Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caitlin.reardon@va.gov.
authors.forename: Caitlin M
authors.initials: CM
authors.lastname: Reardon
authors.affiliation: Baltimore VA Medical Center, Baltimore, MD, USA. nanette.steinle@va.gov.|University of Maryland School of Medicine, Baltimore, MD, USA. nanette.steinle@va.gov.
authors.forename: Nanette
authors.initials: N
authors.lastname: Steinle
authors.affiliation: VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA. jane.weinreb@va.gov.|David Geffen School of Medicine, University of California, Los Angeles, CA, USA. jane.weinreb@va.gov.
authors.forename: Jane
authors.initials: J
authors.lastname: Weinreb
authors.affiliation: Minneapolis VA Healthcare System, Minneapolis, MN, USA. billi005@umn.edu.|University of Minnesota Medical Center, Minneapolis, MN, USA. billi005@umn.edu.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
authors.affiliation: Durham VA Medical Center, Durham, NC, USA. matthew.maciejewski@va.gov.|Duke University School of Medicine, Durham, NC, USA. matthew.maciejewski@va.gov.
authors.forename: Matt L
authors.initials: ML
authors.lastname: Maciejewski
authors.affiliation: Durham VA Medical Center, Durham, NC, USA. will.yancy@duke.edu.|Duke University School of Medicine, Durham, NC, USA. will.yancy@duke.edu.
authors.forename: William S
authors.initials: WS
authors.lastname: Yancy
authors.affiliation: Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. maria.hughes2@va.gov.
authors.forename: Maria
authors.initials: M
authors.lastname: Hughes
authors.affiliation: Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. fatima.makki@va.gov.
authors.forename: Fatima
authors.initials: F
authors.lastname: Makki
authors.affiliation: Ann Arbor VA Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, 48113-0170, USA. caroli@med.umich.edu.|VA Diabetes QUERI, Ann Arbor, MI, USA. caroli@med.umich.edu.|Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. caroli@med.umich.edu.
authors.forename: Caroline R
authors.initials: CR
authors.lastname: Richardson
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D001835:Body Weight; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control; D019317:Evidence-Based Medicine; D006442:Glycated Hemoglobin; D015438:Health Behavior; D006293:Health Promotion / Q000191:economics / Q000458:organization & administration; D008019:Life Style; D012107:Research Design; D014481:United States; D014493:United States Department of Veterans Affairs; D015337:Multicenter Studies as Topic; D002986:Clinical Trials as Topic; D064792:Pragmatic Clinical Trials as Topic
chemical_list: D006442:Glycated Hemoglobin