Improving Mental Health Outcomes: Building an Adaptive Implementation Strategy

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.

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