Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

Not Applicable

Terminated

• Conditions: Bipolar Disorder; Mood Disorder; Depression
• Interventions: Behavioral: External + Internal Facilitation; Behavioral: External Facilitation

• Registration Number: NCT02151331
• Lead Sponsor: University of Michigan

Brief Summary

The overarching goal of this study is to build the most cost-effective adaptive implementation intervention involving a site-level implementation intervention strategy: Replicating Effective Programs (REP), and the augmentation of REP using either External Facilitation or a combination of an External and Internal Facilitation to improve patient outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in community settings.

Detailed Description

Despite the availability of psychosocial evidence-based practices (EBPs), quality and outcomes for persons with mental disorders remain suboptimal because of organizational barriers to implementation. Replicating Effective Programs (REP), a site-level implementation strategy applied to promote the use of psychosocial treatments in community-based practices, still resulted in less than half of sites actually sustaining the use of these treatments. Based on input from community partners and previous research, the study team subsequently enhanced REP to include Facilitation, a novel implementation strategy which addresses site-level organizational barriers to EBP adoption beyond REP's emphasis on fidelity. Two Facilitation roles were developed: External and Internal Facilitators. External Facilitators (EFs) reside outside the clinic, are supported by the study, and provide technical expertise to providers in adapting and using EBPs in routine practice. Internal Facilitators (IFs) are employed by the sites, have a direct reporting relationship to site leadership, and have the local knowledge to help providers implement EBPs. IFs also address site-specific organizational barriers that may not be observable at baseline or by EFs. The overarching goal of this study is to build the most cost-effective adaptive implementation intervention involving REP and the augmentation of the EF and IF roles to improve patient outcomes and the uptake of an EBP for mood disorders (Life Goals-LG) in community settings. The primary aim of this clustered randomized trial is to determine, among sites not initially responding to REP (i.e., limited LG uptake), the effect of adaptive implementation interventions in sites receiving External and Internal Facilitator (REP+EF/IF) versus External Facilitator alone (REP+EF) on improved patient-level outcomes, including mental health quality of life and decreased symptoms, as well as increased LG use among patients with mood disorders after 12 months. Secondary aims are to determine, among sites that continue to exhibit non-response after 12 months, the effect of continuing Facilitation on patient-level outcomes at 24 months, describe the implementation of EF and IF, and to conduct a cost-effectiveness analysis of REP+EF/IF compared to REP+EF over the 24-month period. A representative cohort of 80 community-based outpatient clinics (total 1,600 patients) from different U.S. regions (Michigan, Colorado, and Arkansas) will be included in this study. We will use a Sequential Multiple Assignment Randomized Trial (SMART) design to build the best adaptive implementation intervention. This groundbreaking study design will address three crucial implementation issues: First, IFs are costly for sites since they require additional administrative effort. Second, the extent to which an off-site EF alone versus the addition of an on-site IF can improve patient outcomes in community settings is unclear. Finally, among sites that continue to exhibit non-response after 12 months of Facilitation, the value of continuing the implementation strategy (i.e., delayed effect) has not been assessed, especially in smaller practices from more rural settings.

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Study Start: 2014-08
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2018-10-15
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-15
• Last Update Submitted: 2018-11-15
• Results First Posted: 2018-12-12
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

• Currently being seen at one of the clinics participating in this study
• Diagnosis of or treated for a mood disorder (bipolar disorder or depression)
• Ability to speak and read English and provide informed consent

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Exclusion Criteria

• No active substance intoxication
• No acute medical illness or dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REP + EF/IF	External + Internal Facilitation	Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
REP + EF	External Facilitation	Replication Effective Programs (REP) augmented with External Facilitation (EF)

Primary Outcome Measures

Name	Time	Method
Health-related Quality of Life - Mental Health Component Score	Change from Baseline in Quality of Life at 12-months	Mental Health Quality of Life was measured using the 12-Item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
Reduced Mood Disorder Symptoms	Change from Baseline in Mood Disorder Symptoms at 12-months	Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.

Secondary Outcome Measures

Name	Time	Method
Reduced Mood Disorder Symptoms	Change from Baseline in Mood Disorder Symptoms at 24-months
Health-related Quality of Life - Mental Health Component Score	Change from Baseline in Quality of Life at 24-months	Health-related Quality of Life - Mental Health Component Score of the short form (SF)-12 survey

Trial Locations

Locations (2)

Colorado Access; 🇺🇸 Denver, Colorado, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States