Abstract
BackgroundPersons with serious mental illness (SMI) are disproportionately burdened by premature mortality. This disparity is exacerbated by poor continuity of care with the health system. The Veterans Health Administration (VA) developed Re-Engage, an effective population-based outreach program to identify veterans with SMI lost to care and to reconnect them with VA services. However, such programs often encounter barriers getting implemented into routine care. Adaptive designs are needed when the implementation intervention requires augmentation within sites that do not initially respond to an initial implementation intervention. This protocol describes the methods used in an adaptive implementation design study that aims to compare the effectiveness of a standard implementation strategy (Replicating Effective Programs, or REP) with REP enhanced with External Facilitation (enhanced REP) to promote the uptake of Re-Engage.Methods/DesignThis study employs a four-phase, two-arm, longitudinal, clustered randomized trial design. VA sites (n = 158) across the United States with a designated Re-Engage provider, at least one Veteran with SMI lost to care, and who received standard REP during a six-month run-in phase. Subsequently, 88 sites with inadequate uptake were stratified at the cluster level by geographic region (n = 4) and VA regional service network (n = 20) and randomized to REP (n = 49) vs. enhanced REP (n = 39) in phase two. The primary outcome was the percentage of veterans on each facility outreach list documented on an electronic web registry. The intervention was at the site and network level and consisted of standard REP versus REP enhanced by external phone facilitation consults. At 12 months, enhanced REP sites returned to standard REP and 36 sites with inadequate participation received enhanced REP for six months in phase three. Secondary implementation outcomes included the percentage of veterans contacted directly by site providers and the percentage re-engaged in VA health services.DiscussionAdaptive implementation designs consisting of a sequence of decision rules that are tailored based on a site’s uptake of an effective program may produce more relevant, rapid, and generalizable results by more quickly validating or rejecting new implementation strategies, thus enhancing the efficiency and sustainability of implementation research and potentially leading to the rollout of more cost-efficient implementation strategies.Trial registrationCurrent Controlled Trials ISRCTN21059161.
Highlights
Persons with serious mental illness (SMI) are disproportionately burdened by premature mortality
The Chronic Care Model is a population- and measurement-based approach that calls for healthcare organizations to use electronic registries to monitor vulnerable populations and to adjust treatment according to patient response. Has this model of care been successful in managing mental health across various healthcare settings [9,10], a number of large healthcare providers including the Veterans Health Administration (VA) have demonstrated that this model of care is effective for re-engaging persons with SMI who had been lost to care to prevent adverse health effects [11,12,13]
Covariates of implementation outcomes Drawing on the Consolidated Framework for Implementation Science (CFIR) [68] and the PARiHS Framework, we identified organizational and facility as well as patient-level variables that we will adjust for in examining implementation of Re-Engage
Summary
Persons with serious mental illness (SMI) are disproportionately burdened by premature mortality. Persons with serious mental illnesses (SMI), e.g., bipolar disorder or schizophrenia, experience a disproportionate burden in morbidity and premature mortality from common medical conditions including cardiovascular diseases and certain cancers [1,2,3] These physical health disparities may be exacerbated by long gaps in care from the healthcare system due to psychiatric symptoms or access barriers such as lack of transportation, insurance, or relationship with a primary care provider [4,5]. Has this model of care been successful in managing mental health across various healthcare settings [9,10], a number of large healthcare providers including the Veterans Health Administration (VA) have demonstrated that this model of care is effective for re-engaging persons with SMI who had been lost to care to prevent adverse health effects [11,12,13]
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