Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

November 15, 2018 updated by: Amy M. Kilbourne, University of Michigan

Improving Mental Health Outcomes: Building an Adaptive Implementation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

383

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80231
        • Colorado Access
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REP + EF
Replication Effective Programs (REP) augmented with External Facilitation (EF)
Behavioral: External Facilitation
Non-responding sites randomized to receive external facilitation
Experimental: REP + EF/IF
Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)
Behavioral: External + Internal Facilitation
Non-responding sites randomized to receive both internal and external facilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life - Mental Health Component Score
Time Frame: 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.
Change from Baseline in Quality of Life at 12-months
Reduced Mood Disorder Symptoms
Time Frame: 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.
Change from Baseline in Mood Disorder Symptoms at 12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life - Mental Health Component Score
Time Frame: 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
Change from Baseline in Quality of Life at 24-months
Reduced Mood Disorder Symptoms
Time Frame: Change from Baseline in Mood Disorder Symptoms at 24-months
Change from Baseline in Mood Disorder Symptoms at 24-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Amy M Kilbourne, PhD, MPH, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH099898-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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