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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

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Kilbourne, Amy M, Almirall, Daniel, Eisenberg, Daniel, Waxmonsky, Jeanette, Goodrich, David E, Fortney, John C, Kirchner, JoAnn E, Solberg, Leif I +6 more·2014·Implementation Science
DOI 10.1186/s13012-014-0132-xPMC PMC4189548
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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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02151331.

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Authors
Kilbourne, A. M., Almirall, D., Eisenberg, D., Waxmonsky, J., Goodrich, D. E., Fortney, J. C., Kirchner, J. E., Solberg, L. I., Main, D., Bauer, M. S., Kyle, J., Murphy, S. A., Nord, K. M., & Thomas, M. R.
Affiliations
  • VA Ann Arbor Healthcare System (US)
  • University of Michigan (US)
  • University of Colorado Anschutz (US)
  • Health Services Research & Development (US)
  • Quality Enhancement Research Initiative (US)
  • HealthPartners (US)
  • University of Colorado Denver (US)
  • VA Boston Healthcare System (US)
Corresponding author
Kilbourne, Amy M
ORCID
Venue
Implementation Science
Publisher
Springer Science and Business Media LLC
Published
2014-09-30
Volume
9
Issue
1
Pages
132-132
ISSN
1748-5908 (ISSN-L)
DOI
10.1186/s13012-014-0132-x
PMC
PMC4189548
OpenAlex
W1972388887
Cited by
130
References
143
Citations by year
2026: 3 · 2025: 8 · 2024: 20 · 2023: 14 · 2022: 25 · 2021: 12 · 2020: 14 · 2019: 10 · 2018: 8 · 2017: 8 · 2016: 5 · 2015: 3
FWCI
9.63
Type
journal article
Language
en
Open access
Licence
Locations
  • Implementation Science (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Deep Blue (University of Michigan) (submittedVersion)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Funders
  • U.S. Public Health Service (R01 099898)
  • National Institute of Mental Health (R01MH099898)
  • National Institute on Drug Abuse (P50DA010075)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Social Sciences › Psychology › Clinical Psychology › Psychiatric care and mental health services
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
evidence-based practice uptake, mood disorders, external facilitators, community-based outpatient clinics, mental health-related quality of life, implementation costs, organizational change, sequential multiple assignment randomized trial, ADEPT
MeSH terms
Community Mental Health Services, Humans, Program Development, Evidence-Based Medicine, Mood Disorders, Quality Improvement, Patient Outcome Assessment

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