Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

NCT ID: NCT02151331

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-11-30

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.

Conditions

Bipolar Disorder; Depression; Mood Disorder

Keywords

Chronic care model; Mood disorders; Adaptive implementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

REP + EF

Replication Effective Programs (REP) augmented with External Facilitation (EF)

Group Type: EXPERIMENTAL

External Facilitation

Intervention Type: BEHAVIORAL

Non-responding sites randomized to receive external facilitation

REP + EF/IF

Replicating Effective Programs (REP) augmented with External and Internal Facilitation (EF + IF)

Group Type: EXPERIMENTAL

External + Internal Facilitation

Intervention Type: BEHAVIORAL

Non-responding sites randomized to receive both internal and external facilitation

Interventions

External Facilitation

Non-responding sites randomized to receive external facilitation

Intervention Type: BEHAVIORAL

External + Internal Facilitation

Non-responding sites randomized to receive both internal and external facilitation

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Amy M. Kilbourne

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy M Kilbourne, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Colorado Access

Denver, Colorado, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Eisman AB, Hutton DW, Prosser LA, Smith SN, Kilbourne AM. Cost-effectiveness of the Adaptive Implementation of Effective Programs Trial (ADEPT): approaches to adopting implementation strategies. Implement Sci. 2020 Dec 14;15(1):109. doi: 10.1186/s13012-020-01069-w.

Reference Type: DERIVED

PMID: 33317593 (View on PubMed)

Smith SN, Almirall D, Prenovost K, Liebrecht C, Kyle J, Eisenberg D, Bauer MS, Kilbourne AM. Change in Patient Outcomes After Augmenting a Low-level Implementation Strategy in Community Practices That Are Slow to Adopt a Collaborative Chronic Care Model: A Cluster Randomized Implementation Trial. Med Care. 2019 Jul;57(7):503-511. doi: 10.1097/MLR.0000000000001138.

Reference Type: DERIVED

PMID: 31135692 (View on PubMed)

Kilbourne AM, Almirall D, Eisenberg D, Waxmonsky J, Goodrich DE, Fortney JC, Kirchner JE, Solberg LI, Main D, Bauer MS, Kyle J, Murphy SA, Nord KM, Thomas MR. 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. Implement Sci. 2014 Sep 30;9:132. doi: 10.1186/s13012-014-0132-x.

Reference Type: DERIVED

PMID: 25267385 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

1R01MH099898-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R01MH099898-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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