Kilbourne 2013.

Study characteristics
Methods	Allocation: randomised in blocks of 15 to 20 stratified by age, race and diabetes diagnosis to ensure balance of characteristics Design: RCT, multicentre Duration: 12‐month and 24‐month follow‐up Date of study: May 2008 to May 2012 Country: USA Setting: 2 community‐based mental health outpatient programmes in Southeastern Michigan, in a large VA healthcare system providing services to more than 158,000 veterans living in a 15‐county area Recruitment method: Patients diagnosed with bipolar disorder and a CVD risk factor who received care between fiscal year 2008 and 2009 were identified based on a medical record review of patients. Masking: single‐blind (outcomes assessor blind to intervention)
Participants	Inclusion criteria: adult patients with an active diagnosis or treatment plan for bipolar disorder I, II or NOS with at least one cardiometabolic risk factor (diagnosis or indication of hypertension, hyperlipidaemia, diabetes or BMI > 25) who received care in one of 2 participating community mental health outpatient programmes. Other criteria include community‐dwelling and English‐speaking. Exclusion criteria: severely cognitively impaired or unable to give informed consent Number randomised to intervention and control: 134 participants enrolled and 58 randomised to the Life Goals Collaborative Care group (LGCC), 60 to enhanced treatment as usual (ETU) Number completed study: 118 Age: intervention 53.1 (10.6), control 52.4 (9.2) Sex: intervention 10 (17.2%) female, control 10 (16.7%) female Diagnosis: bipolar I: intervention 20 (34.5%), control 24 (40%); bipolar II: intervention 14 (24.1%), control 12 (20%); bipolar NOS: intervention 21 (36.2%), control 24 (40%); schizoaffective: intervention 3 (5.2%), control 0 (0%) Ethnicity: non‐white: intervention 3 (5.2%), control 3 (5.0%) Any significant differences between intervention and control groups? no statistically significant baseline demographic or clinical differences between the groups
Interventions	Type of collaborative care: A Description of intervention: Intervention name: Life Goals Collaborative Care A multi‐professional approach to patient care: yes, involvement with primary care professionals A structured management plan: yes, interventionist provided four 2‐hour weekly group self‐management sessions, followed by brief care management contacts to patients randomised to LGCC for up to 6 months. Each group session included approximately 8 to 10 participants, and sessions were based on social cognitive theory. The sessions included active discussions by patients that were focused on their personal goals, and alignment of those goals with healthy behaviour changes and action planning to cope with current symptoms. Specific focus points covered throughout the 4 sessions included bipolar disorder and cardiovascular disease risk, stigma issues, wellness habits including diet and exercise within the context of symptom coping strategies, and collaborative care management. Scheduled patient follow‐ups: yes, brief (20‐minute) care management contact with patients in LGCC for up to 6 months. These were used to track symptoms and progress towards wellness goals using motivational techniques. Enhanced interprofessional communication: yes, a nurse care manager served as a liaison between patients and providers regarding ongoing care and, through regular phone calls, the care manager referred urgent matters to medical and mental health providers and was involved in documenting patient progress over time, and outreach/crisis management after critical service encounters or missed appointments. Other intervention components: Brief (20‐minute) care management contact with patients in LGCC for up to 6 months. These were used to track symptoms and progress towards wellness goals using motivational techniques. Improved control of psychiatric symptoms, increased positive health behaviours, as well as improved co‐ordination of physical and mental health care Provider engagement and communication tips Provider contacts (cues) regarding medication side effects, symptoms or urgent health concerns Crisis management Registry tracking Links to community resources Guideline dissemination to health providers of summary information on BD treatment and health issues (e.g. cardiometabolic risk monitoring) The LGCC intervention arm was implemented by a master's level‐trained health specialist. The health specialist's primary roles were to: 1) lead the psychosocial educational group sessions; 2) deliver care management support; and 3) serve as an informational resource to providers by disseminating guidelines and providing information on topics specific to BD treatment and health outcomes. Following randomisation, the health specialist initiated a pre‐session assessment to promote treatment engagement and participation. During this time, the health specialist assessed patient preferences for communication, motivation for health changes, availability for group participation, and principal provider contact information for emergency situations. Participants were then scheduled to attend the group self‐management sessions. Description of control: Enhanced usual care via quarterly newsletters regarding wellness topics mailed to those in the control group. Their general medical and mental health providers received the same practice guideline information at the beginning of the study.
Outcomes	Measures taken at: baseline, 6 months, 12 months, 24 months Primary outcomes: blood pressure, lipids, functioning, non‐fasting blood draw, quality of life Able to use: Quality of life (Short Form 12 ‐ SF‐12) (baseline, 6 months, 12 months, 24 months) Manic and depressive symptoms (Internal State Scale ‐ ISS) (baseline, 6 months, 12 months, 24 months) Blood pressure (diastolic and systolic BP mmHg) (baseline, 6 months, 12 months, 24 months) Body mass index (BMI kg/m2) (baseline, 6 months, 12 months, 24 months) Total cholesterol, high‐density lipoprotein and low‐density lipoprotein (total cholesterol, HDL and LDL levels mg/dL) (baseline, 6 months, 12 months, 24 months) Waist circumference (inches) (baseline, 6 months, 12 months, 24 months) Deaths (all reasons) Attrition (number lost to follow‐up) (12 months, 24 months) Functioning (World Health Organization Disability Assessment Scale WHO‐DAS) (baseline, 6 months, 12 months, 24 months) Estimate of heart attack risk (Framingham Risk Score) (baseline, 6 months, 12 months, 24 months) Unable to use: Haemoglobin A1c levels (HbA1C %) – not reported Estimate of heart attack risk (Framingham Risk Score) – not of interest
Notes	Self‐Management Addressing Heart Risk Trial (SMAHRT), a randomised controlled effectiveness trial of an intervention (Life Goals Collaborative Care; LGCC) designed to reduce CVD risk factors and improve physical and mental health outcomes in patients with BD Conducted May 2008 to May 2012