title: Partnering with health system operations leadership to develop a controlled implementation trial.
abstract: BACKGROUND
  Outcome for mental health conditions is suboptimal, and care is fragmented. Evidence from controlled trials indicates that collaborative chronic care models (CCMs) can improve outcomes in a broad array of mental health conditions. US Department of Veterans Affairs leadership launched a nationwide initiative to establish multidisciplinary teams in general mental health clinics in all medical centers. As part of this effort, leadership partnered with implementation researchers to develop a program evaluation protocol to provide rigorous scientific data to address two implementation questions: (1) Can evidence-based CCMs be successfully implemented using existing staff in general mental health clinics supported by internal and external implementation facilitation? (2) What is the impact of CCM implementation efforts on patient health status and perceptions of care?
  
  
  METHODS
  Health system operation leaders and researchers partnered in an iterative process to design a protocol that balances operational priorities, scientific rigor, and feasibility. Joint design decisions addressed identification of study sites, patient population of interest, intervention design, and outcome assessment and analysis. Nine sites have been enrolled in the intervention-implementation hybrid type III stepped-wedge design. Using balanced randomization, sites have been assigned to receive implementation support in one of three waves beginning at 4-month intervals, with support lasting 12 months. Implementation support consists of US Center for Disease Control's Replicating Effective Programs strategy supplemented by external and internal implementation facilitation support and is compared to dissemination of materials plus technical assistance conference calls. Formative evaluation focuses on the recipients, context, innovation, and facilitation process. Summative evaluation combines quantitative and qualitative outcomes. Quantitative CCM fidelity measures (at the site level) plus health outcome measures (at the patient level; n = 765) are collected in a repeated measures design and analyzed with general linear modeling. Qualitative data from provider interviews at baseline and 1 year elaborate CCM fidelity data and provide insights into barriers and facilitators of implementation.
  
  
  CONCLUSIONS
  Conducting a jointly designed, highly controlled protocol in the context of health system operational priorities increases the likelihood that time-sensitive questions of operational importance will be answered rigorously and that the outcomes will result in sustainable change in the health-care system.
  
  
  BACKGROUND
  NCT02543840 ( https://www.clinicaltrials.gov/ct2/show/NCT02543840).
authors.affiliation: VA Boston Healthcare System, Harvard Medical School, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. mark.bauer@va.gov.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Bauer
authors.affiliation: VA Boston Healthcare System, Harvard Medical School, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Christopher.Miller8@va.gov.
authors.forename: Christopher
authors.initials: C
authors.lastname: Miller
authors.affiliation: VA Boston Healthcare System, Harvard Medical School, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Bo.Kim@va.gov.
authors.forename: Bo
authors.initials: B
authors.lastname: Kim
authors.affiliation: VA Boston Healthcare System, Boston University School of Medicine, 150 South Huntington Avenue (MAVERIC), Boston, MA, 02130, USA. Robert.Lew2@va.gov.
authors.forename: Robert
authors.initials: R
authors.lastname: Lew
authors.affiliation: James H. Quillen VA Medical Center, Corner of Lamont & Veterans Way, Mountain Home, TN, 37684, USA. Kendra.Weaver@va.gov.
authors.forename: Kendra
authors.initials: K
authors.lastname: Weaver
authors.affiliation: VA New England Healthcare System, Boston University School of Medicine, 200 Springs Road, Building 61 (136G), Bedford, MA, 01730, USA. Craig.Coldwell@va.gov.
authors.forename: Craig
authors.initials: C
authors.lastname: Coldwell
authors.affiliation: Central Arkansas Veterans Healthcare System, University of Arkansas for Medical Sciences, 2200 Fort Roots Drive, Building 58, North Little Rock, AR, 72114, USA. Henderson.Kathy@va.gov.
authors.forename: Kathy
authors.initials: K
authors.lastname: Henderson
authors.affiliation: VA Boston Healthcare System, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Sally.Holmes@va.gov.
authors.forename: Sally
authors.initials: S
authors.lastname: Holmes
authors.affiliation: VA Boston Healthcare System, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Marjorie.NealonSeibert@va.gov.
authors.forename: Marjorie Nealon
authors.initials: MN
authors.lastname: Seibert
authors.affiliation: VA Boston Healthcare System, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Kelly.stolzmann@va.gov.
authors.forename: Kelly
authors.initials: K
authors.lastname: Stolzmann
authors.affiliation: VA Boston Healthcare System, 150 South Huntington Avenue (152M), Boston, MA, 02130, USA. Rani.elwy@va.gov.
authors.forename: A Rani
authors.initials: AR
authors.lastname: Elwy
authors.affiliation: Central Arkansas Veterans Healthcare System, University of Arkansas for Medical Sciences, 2200 Fort Roots Drive, Building 58, North Little Rock, AR, 72114, USA. JoAnn.Kirchner@va.gov.
authors.forename: JoAnn
authors.initials: J
authors.lastname: Kirchner
mesh_terms: D003299:Cooperative Behavior; D003695:Delivery of Health Care; D006297:Health Services Accessibility; D006801:Humans; D001523:Mental Disorders; D010346:Patient Care Management; D016730:Program Development / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D012648:Self Care