Rost 2001a.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Patients screened first‐stage positive for depression if they reported on Composite International Diagnostic Interview (CIDI) questions they had experienced 2 weeks or more during the last year when they felt sad, empty, depressed, or lost interest in things they normally enjoyed and reported 1 week or more of these symptoms during the past month. Second stage screening: reporting 5 or more of 9 criteria for major depression in the past 2 weeks on the Inventory to Diagnose Depression. Meeting DSM‐III‐R criteria for major depression in the past two weeks. Depression severity measured by a modified 23 item Centre for Epidemiologic Studies depression scale (mCES‐D) Inclusion criteria: Age 18 or over, not pregnant, breastfeeding or less than 3 months post‐partum, sufficient literacy in English and cognitive function to complete surveys requiring 6‐month recall, no acute life threatening physical conditions; and access to a telephone Exclusion criteria: Depressive symptoms had begun after the loss of a loved one within the last 2 months to exclude patients with bereavement. Patients were also excluded if they noted that they did not intend to receive ongoing care in the clinic during the next year to target the intervention to patients who could participate in it over time. Screening positive by self‐report for lifetime mania, use of lithium, or current alcohol dependence Age: 42.6 (SD 13.1) years Gender: 84% female Ethnicity: 16% ethnic minority Country: United States Sample size (randomised): Total clusters 12, intervention 6 (4 urban and 2 rural), control 6 (4 urban and 2 rural); Total participants (Recently treated) 479, intervention 239, control 240 |
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| Interventions | Intervention: Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), nurse (CM), social worker/psychiatrist (MH specialist) 2) a structured management plan: CMs assessed patients, evaluated treatment preferences (pharmacotherapy, psychotherapy, watchful waiting), and addressed barriers to care. A checklist was then provided to the PCP who then saw the patient. CMs provided written information on preferred treatment, the homework assignment they had agreed upon, and the time/place of next CM contact. CMs used a similar protocol to guide subsequent sessions. With PCP supervision, CMs provided medication samples to patients who could not afford them 3) scheduled patient follow‐ups: Face‐to‐face assessment followed by 5 weekly telephone or face‐to‐face contacts with the option of extending the protocol for 2 additional weeks 4) enhanced inter‐professional communication: CMs provided information from assessment and follow‐up to PCPs. PCPs were offered MH specialist consultation. CMs received supervision from MH specialist (social worker) Control: Treatment as usual |
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| Outcomes | Depression (mCESD): 6 months Medication use: 6 months Satisfaction: 6 months |
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| Notes | CIDI: Composite International Diagnostic Interview; CM: case manager; MH: mental health; PCP: primary care provider; SD: standard deviation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Clusters were randomised in blocks of 2, with 1:1 allocation ratio, using coin‐toss |
| Allocation concealment (selection bias) | Unclear risk | Clusters were identified by a number and paired by the Principle Investigator based on proportions |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (mCESD) was: overall 26/268 (10%), 12/124 (10%) intervention and 14/144 (10%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | Protocol available and all prespecified outcomes reported |
| Other bias | Unclear risk | Insufficient information available to assess |
| Implementation Integrity | Unclear risk | Insufficient information available to assess |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor was not aware of treatment allocation |