Bauer 2006.

Study characteristics
Methods	Allocation: randomised Design: RCT, multicentre (11 outpatient VAMC clinics) Duration: 36‐month (156‐week) follow‐up Date of study: July 1997 to December 2003 Country: USA Setting: outpatient clinics at VAMC Recruitment method: Potential participants were identified during acute hospitalisation for bipolar disorder and randomly assigned at discharge to either continue usual outpatient care or receive care in the intervention clinic for 3 years. Masking: none. “Because participants could not be blinded to the intervention, we could not guarantee blinding of the research assistants.”
Participants	Inclusion criteria: diagnosis of bipolar disorder type I or II by criteria on the Structured Clinical Interview for Axis I DSM‐IV Disorders; all psychiatric and medical comorbidities were allowed except as specified below; index episode of manic, major depressive or mixed episode, by DSM‐IV criteria, requiring hospitalisation on an acute psychiatric ward; at least 2 hospitalisations on acute psychiatric wards more than 3 months apart over the prior 5 years Exclusion criteria: moderate to severe dementia, with a Mini‐Mental State Examination score of ≤ 26; unresolved substance intoxication or withdrawal; hospitalisation on chronic or acute psychiatric wards for 6 or more months in the past year; ongoing enrolment in mental health programmes with a mobile outreach component in which clinical caregivers deliver services to the patient in the community; terminal medical illness with less than 3 years of expected longevity; unable or unwilling to give informed consent or in other ways unable to complete study requirements; participation in another concurrent experimental mental health or medical‐surgical treatment protocol Number randomised to intervention and control: 330, 166 intervention, 164 control Number completed study: 306 Age: 46.6 years mean (SD 10.1), not reported by control vs intervention Sex: female 28 (9%), not reported by control vs intervention Diagnosis: bipolar 1 265 (87%); bipolar 2 41 (23%), not reported by control vs intervention Ethnicity: minority 71 (23%), not reported by control vs intervention Any significant differences between intervention and control groups? Participants in the intervention and usual care arms of the study did not differ in demographic or clinical characteristics except that intervention participants were somewhat older, less likely to have had a prior suicide attempt and more likely to have a diagnosis of a substance use disorder over their lifetime. Current substance disorder prevalence did not differ between groups.
Interventions	Type of collaborative care: B Description of intervention: Intervention name: collaborative care for bipolar disorder Contains 3 of 4 elements of collaborative care: A multi‐professional approach to patient care: no, there is no primary carer provider collaboration, instead the collaboration is between the nurse and the patient A structured management plan: yes, clear protocols and algorithms for each part of the programme Scheduled patient follow‐ups: yes, there are scheduled follow‐up plans with a minimum of once every 3‐monthly contact Enhanced interprofessional communication: yes, nurse manages communication with other healthcare providers and patient Other key elements of the intervention: Psycho‐education delivered to participants to encourage active self‐management and monitoring of symptoms and functioning Health promotion activities Collaborative definition of problems Joint goal‐setting and planning Practice guidelines for healthcare providers Delivered in an outpatient specialist mental health clinic by a psychiatrist (0.25 FTE) and NCC (0.5 FTE) Description of control: Usual care; participants continued with their previous psychiatrist or were assigned one if new to VA. Clinicians who cared for participants in usual care did not care for those in collaborative care.
Outcomes	Measures taken at: not clearly specified. States, "The outcome battery was administered in 45 to 75 minutes every eight weeks and covered clinical and functional outcome, quality of life, non‐VA clinical service use, and selected process measures"; however, some contradicting information is indicated below: Primary outcomes: 1) manic symptom score; 2) depressive symptom score; 3) total treatment costs Able to use: Psychiatric admissions Other hospital admissions (any reason) Death (all causes and suicide) Quality of life (SF‐36 mental component and SF‐36 physical component) (every 24 weeks) Cost (mean intervention costs) (36 months) Attrition (number lost to follow‐up) (36 months) Unable to use: Clinical outcome (Longitudinal Interval Follow‐up Examination – LIFEscale) (every 8 weeks) – no mean or SD reported Social functioning (Social Adjustment Scale II) (every 8 weeks) ‐ no mean or SD reported Intensity of bipolar‐specific pharmacotherapy (adaptation of the National Institute of Mental Health Collaborative Study instrument) (every 24 weeks) Patient satisfaction (Patient Satisfaction Index) ‐ not eligible for inclusion in the review Costs (direct all‐treatment costs, psychiatric inpatient costs, inpatient costs, medical surgical inpatient costs, outpatient costs) ‐ data not reported fully
Notes	% lost to follow‐up: The overall protocol completion rate to week 156 was 80% and did not differ by survival analysis between intervention and usual care (respectively, 75% and 85%) or by mean retention in the protocol (123.5 ± 50.4 compared with 120.2 ± 52.0 weeks). Early terminators did not differ from completers in gender, age, homelessness, prior suicide attempts or psychosis. Ninety‐six percent of all cost data points were available. Deaths did not differ (intervention, 12 deaths among 166 participants (7%); usual care, 8 deaths among 164 (5%)). There were 12 medical deaths, 4 accidents, 1 suicide (usual care participant) and 3 deaths from unknown causes. Standard deviations were imputed from the figures reported by study authors.