Clinical trial NCT02151331: Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy
Official title: Improving Mental Health Outcomes: Building an Adaptive Implementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Depression
Mood Disorder
Keywords: Chronic care model
Mood disorders
Adaptive implementation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-05-30
Enrollment: 383
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Health-related Quality of Life - Mental Health Component Score
timeFrame: Change from Baseline in Quality of Life at 12-months
measure: Reduced Mood Disorder Symptoms
timeFrame: Change from Baseline in Mood Disorder Symptoms at 12-months
Secondary outcomes:
measure: Health-related Quality of Life - Mental Health Component Score
timeFrame: Change from Baseline in Quality of Life at 24-months
measure: Reduced Mood Disorder Symptoms
timeFrame: Change from Baseline in Mood Disorder Symptoms at 24-months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Access
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy M Kilbourne, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.