title: Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.
abstract: BACKGROUND
  Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months.
  
  
  METHODS
  This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as < 50% patients receiving ≥ 3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change.
  
  
  CONCLUSIONS
  This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02151331.
authors.affiliation: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Rd, Mailstop 152, Ann Arbor 48105, MI, USA. amykilbo@umich.edu.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Kilbourne
authors.forename: Daniel
authors.initials: D
authors.lastname: Almirall
authors.forename: Daniel
authors.initials: D
authors.lastname: Eisenberg
authors.forename: Jeanette
authors.initials: J
authors.lastname: Waxmonsky
authors.forename: David E
authors.initials: DE
authors.lastname: Goodrich
authors.forename: John C
authors.initials: JC
authors.lastname: Fortney
authors.forename: JoAnn E
authors.initials: JE
authors.lastname: Kirchner
authors.forename: Leif I
authors.initials: LI
authors.lastname: Solberg
authors.forename: Deborah
authors.initials: D
authors.lastname: Main
authors.forename: Mark S
authors.initials: MS
authors.lastname: Bauer
authors.forename: Julia
authors.initials: J
authors.lastname: Kyle
authors.forename: Susan A
authors.initials: SA
authors.lastname: Murphy
authors.forename: Kristina M
authors.initials: KM
authors.lastname: Nord
authors.forename: Marshall R
authors.initials: MR
authors.lastname: Thomas
mesh_terms: D003156:Community Mental Health Services / Q000379:methods / Q000458:organization & administration / Q000592:standards; D019317:Evidence-Based Medicine; D006801:Humans; D019964:Mood Disorders / Q000628:therapy*; D063868:Patient Outcome Assessment; D016730:Program Development; D058996:Quality Improvement / Q000458:organization & administration*