Kristina M. Nord

Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT).

OBJECTIVES Persons with bipolar disorder experience a disproportionate burden of medical conditions, notably cardiovascular disease (CVD), leading to impaired functioning and premature mortality. We hypothesized that the Life Goals Collaborative Care (LGCC) intervention, compared to enhanced usual care, would reduce CVD risk factors and improve physical and mental health outcomes in US Department of Veterans Affairs patients with bipolar disorder. METHOD Patients with an 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). Life Goals Collaborative Care included 4 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 during a 12-month period in addition to standard treatment. Primary outcome measures included systolic and diastolic blood pressure, nonfasting total cholesterol, and physical health-related quality of life. RESULTS Of the 180 eligible patients identified for study participation, 134 were enrolled (74%) and 118 completed outcomes assessments (mean age = 53 years, 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 (β = -3.1, P = .04) and diastolic blood pressure (β = -2.1, P = .04) as well as reduced manic symptoms (β = -23.9, P = .01). Life Goals Collaborative Care had no significant impact on other primary outcomes (total cholesterol and physical health-related quality of life). CONCLUSIONS Life Goals Collaborative Care, compared to enhanced usual care, may lead to reduced CVD risk factors, notably through decreased blood pressure, as well as reduced manic symptoms, in patients with bipolar disorder. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00499096.

Mental Health Collaborative Care and Its Role in Primary Care Settings

Collaborative care models (CCMs) provide a pragmatic strategy to deliver integrated mental health and medical care for persons with mental health conditions served in primary care settings. CCMs are team-based intervention to enact system-level redesign by improving patient care through organizational leadership support, provider decision support, and clinical information systems, as well as engaging patients in their care through self-management support and linkages to community resources. The model is also a cost-efficient strategy for primary care practices to improve outcomes for a range of mental health conditions across populations and settings. CCMs can help achieve integrated care aims underhealth care reform yet organizational and financial issues may affect adoption into routine primary care. Notably, successful implementation of CCMs in routine care will require alignment of financial incentives to support systems redesign investments, reimbursements for mental health providers, and adaptation across different practice settings and infrastructure to offer all CCM components.

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

BackgroundDespite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months.Methods/DesignThis study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as <50% patients receiving ≥3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change.DiscussionThis study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF.Trial registrationClinicalTrials.gov identifier: NCT02151331

Enhanced Fidelity to Treatment for Bipolar Disorder: Results From a Randomized Controlled Implementation Trial

OBJECTIVE The authors compared fidelity to bipolar disorder treatment at community practices that received a standard or enhanced version of a novel implementation intervention called Replicating Effective Programs (REP). METHODS Five community practices in Michigan and Colorado were assigned at random to receive enhanced (N=3) or standard (N=2) REP to help implement Life Goals Collaborative Care (LGCC), a psychosocial intervention consisting of four self-management support group sessions, ongoing care management contacts by phone, and dissemination of guidelines to providers. Standard REP includes an intervention package consisting of an outline, a treatment manual and implementation guide, a standard training program, and as-needed technical assistance. Enhanced REP added customization of the treatment manual and ongoing, proactive technical assistance from internal and external facilitators. Multiple and logistic regression analyses determined the impact of enhanced versus standard REP on patient-level fidelity. RESULTS The participants (N=384) had a mean age of 42 years; 67% were women, and 30% were nonwhite. Participants attended an average of three group sessions and had an average of four care management contacts. After adjustment for patient factors, enhanced REP was associated with 2.6 (p<.001) times more total sessions and contacts than standard REP, which was driven by 2.5 (p<.01) times more care management contacts. Women and participants with a history of homelessness had fewer total sessions and contacts. CONCLUSIONS Enhanced REP was associated with improved LGCC fidelity, primarily for care management contacts. Additional customization of interventions such as LGCC may be needed to ensure adequate treatment fidelity for vulnerable populations.

Quality of life among patients with bipolar disorder in primary care versus community mental health settings

INTRODUCTION Bipolar disorder is associated with functional impairment across a number of domains, including health-related quality of life (HRQOL). Many patients are treated exclusively in primary care (PC) settings, yet little is known how HRQOL outcomes compare between PC and community mental health (CMH) settings. This study aimed to explore the correlates of HRQOL across treatment settings using baseline data from a multisite, randomized controlled trial for adults with bipolar disorder. METHODS HRQOL was measured using the SF-12 physical (PCS) and mental (MCS) composite scale scores. Independent sample t-tests were calculated to compare differences in HRQOL between settings. Multivariate regression models then examined the effect of treatment setting on HRQOL, adjusting for covariate demographic factors, mood symptoms (Internal State Scale), hazardous drinking (AUDIT-C), and substance abuse. RESULTS A total of 384 enrolled participants completed baseline surveys. MCS and PCS scores reflected similar impairment in HRQOL across PC and CMH settings (p=0.98 and p=0.49, respectively). Depressive symptoms were associated with lower MCS scores (B=-0.68, p<0.001) while arthritis/chronic pain was strongly related to lower PCS scores (B=-5.23, p<0.001). LIMITATIONS This study lacked a formal diagnostic interview, relied on cross-sectional self-report, and sampled from a small number of sites in two states. DISCUSSION Participants reported similar impairments in both mental and physical HRQOL in PC and CMH treatment settings, emphasizing the need for integrated care for patients with bipolar disorder regardless of where they present for treatment.

SMI life goals: description of a randomized trial of a collaborative care model to improve outcomes for persons with serious mental illness.

BACKGROUND Persons with serious mental illnesses (SMI) are more likely to die earlier than the general population, primarily due to increased medical burden, particularly from cardiovascular disease (CVD). Life Goals Collaborative Care (LG-CC) is designed to improve health outcomes in SMI through self-management, care management, and provider support. This single-blind randomized controlled effectiveness study will determine whether patients with SMI receiving LG-CC compared to usual care (UC) experience improved physical health in 12 months. METHODS Patients diagnosed with SMI and at least one CVD risk factor receiving care at a VA mental health clinic were randomized to LG-CC or UC. LG-CC included five self-management sessions covering mental health symptom management reinforced through health behavior change, care coordination and health monitoring via a registry, and provider feedback. The primary outcome is change in physical health-related quality of life score (VR-12) from baseline to 12 months. Secondary outcomes include changes in mental health-related quality of life, CVD risk factors (blood pressure, BMI), and physical activity from baseline to 12 months later. RESULTS Out of 304 enrolled, 139 were randomized to LG-CC and 145 to UC. Among patients completing baseline assessments (N = 284); the mean age was 55.2 (SD = 10.9; range 28-75 years), 15.6% were women, the majority (62%) were diagnosed with depression, and the majority (63%) were diagnosed with hypertension or were overweight (BMI mean ± SD = 33.3 ± 6.3). Baseline VR-12 physical health component score was below population norms (50.0 ± SD = 10) at 33.4 ± 11.0. CONCLUSIONS Findings from this trial may inform initiatives to improve physical health for SMI patient populations.

Reengaging Veterans With Serious Mental Illness Into Care: Preliminary Results From a National Randomized Trial

OBJECTIVE This study compared effectiveness of an enhanced versus standard implementation strategy (Replicating Effective Programs [REP]) on site-level uptake of Re-Engage, a national program for veterans with serious mental illness. METHODS Mental health providers at 158 Veterans Affairs (VA) facilities were given REP-based manuals and training in Re-Engage, which involved identifying veterans who had not been seen in VA care for at least one year, documenting their clinical status, and coordinating further health care. After six months, facilities not responding to REP (N=88) were randomized to receive six months of facilitation (enhanced REP) or continued standard REP. Site-level uptake was defined as percentage of patients (N=1,531) with updated documentation or with whom contact was attempted. RESULTS Rate of Re-Engage uptake was greater for enhanced REP sites compared with standard REP sites (41% versus 31%, p=.01). Total REP facilitation time was 7.3 hours per site for six months. CONCLUSIONS Added facilitation improved short-term uptake of a national mental health program.

Improving physical health in patients with chronic mental disorders: Twelve-month results from a randomized controlled collaborative care trial

OBJECTIVE Persons with chronic mental disorders are disproportionately burdened with physical health conditions. We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months. METHODS This single-blind randomized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic. Patients (N = 293 out of 474 eligible approached) with an ICD-9-CM diagnosis of schizophrenia, bipolar disorder, or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were randomized (February 24, 2010, to April 29, 2015) to Life Goals (n = 146) or usual care (n = 147). A total of 287 completed baseline assessments, and 245 completed 12-month follow-up assessments. Life Goals included 5 weekly sessions that provided semistructured guidance on managing physical and mental health symptoms through healthy behavior changes, augmented by ongoing care coordination. The primary outcome was change in physical health-related quality of life score (Veterans RAND 12-item Short Form Health Survey [VR-12] physical health component score). Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months (blood pressure, lipids, weight), mental health-related quality of life, and mental health symptoms. RESULTS Among patients completing baseline and 12-month outcomes assessments (N = 245), the mean age was 55.3 years (SD = 10.8; range, 25-78 years), and 15.4% were female. Intent-to-treat analysis revealed that compared to those in usual care, patients randomized to Life Goals had slightly increased VR-12 physical health scores (coefficient = 3.21; P = .01). CONCLUSIONS Patients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT01487668 and NCT01244854.

Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices

BackgroundMood disorders represent the most expensive mental disorders for employer-based commercial health plans. Collaborative care models are effective in treating chronic physical and mental illnesses at little to no net healthcare cost, but to date have primarily been implemented by larger healthcare organizations in facility-based models. The majority of practices providing commercially insured care are far too small to implement such models. Health plan-level collaborative care treatment can address this unmet need. The goal of this study is to implement at the national commercial health plan level a collaborative care model to improve outcomes for persons with mood disorders.Methods/DesignA randomized controlled trial of a collaborative care model versus usual care will be conducted among beneficiaries of a large national health plan from across the country seen by primary care or behavioral health practices. At discharge 344 patients identified by health plan claims as hospitalized for unipolar depression or bipolar disorder will be randomized to receive collaborative care (patient phone-based self-management support, care management, and guideline dissemination to practices delivered by a plan-level care manager) or usual care from their provider. Primary outcomes are changes in mood symptoms and mental health-related quality of life at 12 months. Secondary outcomes include rehospitalization, receipt of guideline-concordant care, and work productivity.DiscussionThis study will determine whether a collaborative care model for mood disorders delivered at the national health plan level improves outcomes compared to usual care, and will inform a business case for collaborative care models for these settings that can reach patients wherever they receive treatment.Trial registrationClinicalTrials.gov Identifier: NCT02041962; registered January 3, 2014.

Physical Health Conditions Among a Population-Based Cohort of Vietnam-Era Women Veterans: Agreement Between Self-Report and Medical Records

BACKGROUND Little is known about medical morbidity among women Vietnam-era veterans, or the long-term physical health problems associated with their service. This study assessed agreement comparing data on physical health conditions from self-report and medical records from a population-based cohort of women Vietnam-era Veterans from the Health of Vietnam Era Womens Study (HealthViEWS). MATERIALS AND METHODS Women Vietnam-era veterans (n = 4219) self-completed a survey and interview on common medical conditions. A subsample (n = 900) were contacted to provide permission to obtain medical records from as many as three of their providers. Medical record reviews were conducted using a standardized checklist. Agreement and kappa (agreement beyond chance) were calculated for physical health condition groups. RESULTS Of the 900, 449 had medical records returned, and of those, 412 had complete surveys/interviews. The most commonly reported conditions based on self-report or medical record review included hypertension, hyperlipidemia, or arthritis. Kappa scores between self-reported conditions and medical record documentation were 0.75-0.91 for hypertension, diabetes, most cancers, and neurological conditions, but lower (k = 0.29-0.55) for cardiovascular diseases, musculoskeletal, and gastrointestinal conditions. Generally, agreement did not significantly vary by different sociodemographic groups. CONCLUSIONS There was relatively high agreement for physical health conditions when self-report was compared with medical record review. As more women are increasingly represented in the military and more veterans in general seek care outside the Veterans Health Administration, accurate measurement of physical health conditions among population-based samples is crucial.