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Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

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ClinicalTrials.gov Identifier: NCT02151331
Recruitment Status : Terminated (Sponsor requested termination due to low recruitment numbers)
First Posted : May 30, 2014
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy M. Kilbourne, 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Mood Disorder Behavioral: External Facilitation Behavioral: External + Internal Facilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Mental Health Outcomes: Building an Adaptive Implementation
Study Start Date : August 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. Reduced Mood Disorder Symptoms [ Time Frame: Change from Baseline in Mood Disorder Symptoms at 24-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151331


Locations
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United States, Colorado
Colorado Access
Denver, Colorado, United States, 80231
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Amy M Kilbourne, PhD, MPH University of Michigan
  Study Documents (Full-Text)

Documents provided by Amy M. Kilbourne, University of Michigan:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy M. Kilbourne, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT02151331    
Other Study ID Numbers: 1R01MH099898-01A1 ( U.S. NIH Grant/Contract )
1R01MH099898-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2014    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: November 2018
Keywords provided by Amy M. Kilbourne, University of Michigan:
Chronic care model
Mood disorders
Adaptive implementation
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders