Hedrick 2003.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Current major depressive episode, dysthymia, or both. Assessed using Primary care evaluation of Mental Disorders (PRIME‐MD) and additional questions from the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) Inclusion criteria: Veterans Exclusion criteria: Recent visit to mental health specialty clinic or who had scheduled a future appointment, requiring treatment for substance abuse or PTSD prior to initiating depression treatment, acute suicidality, psychosis or other condition requiring immediate treatment Age: Mean 57.2 years Gender: 5% female Ethnicity: 80% caucasian Country: United States Sample size (randomised): Total clusters 4, intervention 2, control 2; Total participants 354, intervention 168, control 186 |
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| Interventions | Intervention: Collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), social worker (CM), psychiatrist (MH specialist) 2) a structured management plan: The team (CM, MH specialist, psychologist and psychologist technician) met weekly to develop treatment plans and conduct 6 and 12 week progress evaluations for each patient. Using Veteran Affairs Major Depression Guidelines treatment options were: AD medication; add an adjunctive medication; a CBT group; schedule with the psychologist or psychiatrist; or refer to MH speciality care. Options were selected beginning with the least resource‐ intensive option based on previous treatments and patient preference. Patients were stepped up if non‐response at 6 or 12 weeks. A videotape and workbook were mailed to each patient. CMs telephoned patients on a regular schedule to encourage adherence, address treatment barriers, and assess response. 3) scheduled patient follow‐ups: Acute = 3 to 5 telephone calls, maintenance = 3 to 5 calls, plus for those also receiving CBT = 6 sessions 4) enhanced inter‐professional communication: The team liaised with PCP re medication prescribing and treatment plans using electronic progress notes and if not acted upon the team contacted the PCP directly. The MH specialist contacted PCPs where there was question about treatment recommendations Control: Consultation‐liaison (CL) in which the PCP was responsible for initiating and coordinating the patient's care, with consultation from or referral to a psychiatrist if necessary. PCPs were notified of the patient's diagnosis and were able to refer patients to the psychiatrist, psychologist, and/or social workers, based in the organisation. The CL mental health providers provided treatment directly during individual visits with patients who were deemed manageable in the primary care setting |
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| Outcomes | Depression (HSCL): 3, 9 months Medication use: 3, 6, 9, 12 months Quality of Life (mental and physical health): 3, 9 months Satisfaction: 3, 9 months |
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| Notes | AD: antidepressant; CBT: cognitive behaviour therapy; CM: case manager; HSCL: Hopkins Sympton Checklist; MH: mental health; PCP: primary care provider | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information available to assess |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information available to assess |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL ≥ 50%) was: overall 26/354 (7%), 12/168 (7%) intervention and 14/186 (8%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information available to assess |
| 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 |