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Published in: Implementation Science 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Amy M Kilbourne, Daniel Almirall, Daniel Eisenberg, Jeanette Waxmonsky, David E Goodrich, John C Fortney, JoAnn E Kirchner, Leif I Solberg, Deborah Main, Mark S Bauer, Julia Kyle, Susan A Murphy, Kristina M Nord, Marshall R Thomas

Published in: Implementation Science | Issue 1/2014

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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 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
Appendix
Available only for authorised users
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Metadata
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
Authors
Amy M Kilbourne
Daniel Almirall
Daniel Eisenberg
Jeanette Waxmonsky
David E Goodrich
John C Fortney
JoAnn E Kirchner
Leif I Solberg
Deborah Main
Mark S Bauer
Julia Kyle
Susan A Murphy
Kristina M Nord
Marshall R Thomas
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2014
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-014-0132-x

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