Objectives Persons with bipolar disorder experience a disproportionate burden of medical conditions, notably cardiovascular disease (CVD), leading to impaired functioning and premature mortality. The study objective was to determine whether the Life Goals Collaborative Care (LGCC) intervention compared to enhanced usual care, reduced CVD risk factors and improved physical and mental health outcomes in VA patients with bipolar disorder. Method Patients with ICD-9 diagnosis of bipolar disorder and >=1 CVD risk factor (n=118) enrolled in the Self-Management Addressing Heart Risk Trial conducted April 2008–May 2010, were randomized to LGCC (N=58) or enhanced usual care (N=60). LGCC included four weekly self-management sessions followed by tailored contacts combining health behavior change strategies, medical care management, registry tracking, and provider guideline support. Enhanced usual care included quarterly wellness newsletters sent over a 12-month period in addition to standard treatment. Results Out of the 180 eligible patients identified for study participation, 134 were enrolled (74%) and 118 completed outcomes assessments (mean age = 53, 17% female, 5% African American). Mixed effects analyses comparing changes in 24-month outcomes among patients in LGCC (N=57) versus enhanced usual care (N=59) groups revealed that patients receiving LGCC had reduced systolic (Beta=−3.1, P=.04) and diastolic blood pressure (Beta=−2.1, P=.04) as well as reduced manic symptoms (Beta=−23.9, P=.01). LGCC had no significant impact on other primary outcomes (total cholesterol, physical health-related quality of life). Conclusions LGCC compared to enhanced usual care may lead to reduced CVD risk factors, notably through decreased blood pressure, as well as reduced manic symptoms.

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.

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