Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

Depression Clinical Trial

Official title:

Improving Mental Health Outcomes: Building an Adaptive Implementation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02151331
• Other study ID #: 1R01MH099898-01A1
• Secondary ID: 1R01MH099898-01A
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 383
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• Mood Disorder
• Mood Disorders

Intervention

Behavioral:
• External Facilitation
Non-responding sites randomized to receive external facilitation
• External + Internal Facilitation
Non-responding sites randomized to receive both internal and external facilitation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Colorado Access	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life - Mental Health Component Score	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
Primary	Reduced Mood Disorder Symptoms	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	Health-related Quality of Life - Mental Health Component Score	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
Secondary	Reduced Mood Disorder Symptoms		Change from Baseline in Mood Disorder Symptoms at 24-months