Swindle 2003.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Major depression, dysthymia, or partially remitted major depression using PRIME‐MD structured diagnostic interview Inclusion criteria: 2 or more general medicine clinic visits during the past year and plans to receive ongoing medical care from insurance group, access to a telephone and provided informed consent Exclusion criteria: Incompetent for interview (e.g. active psychosis, dementia), residents of a nursing home, actively suicidal, seen in a Veterans Affairs Medical Centres mental health programme (made a visit during the previous 30 days and had a future appointment scheduled), active cocaine or opiate abuser, history of bipolar disorder, terminally ill (death expected within 12 months) Age: Mean 56.3 years Gender: 3% female Ethnicity: 86% Caucasian Country: United States Sample size (randomised): Total clusters 2, intervention 1, control 1; Total participants 268, intervention 134, control 134 |
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| Interventions | Intervention: Integrated care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), MH nurse specialist (CM), psychiatrist (MH specialist) 2) a structured management plan: CMs and patients developed individual treatment plans including medication prescription (recommendation of initial 8 week course typically SSRI for those not currently on ADs), change in AD or dose (for those still symptomatic on current medication), onward referral to CBT or specialist care (for those with non‐response to current medication);and liaison with PCP. CMs monitored progress including depressive symptoms, review side effects, encourage treatment compliance, schedule further visits to themselves or PCPs to modify medication and/or refer to mental health specialists 3) scheduled patient follow‐ups: 4 contacts at baseline, 2 weeks, one month and two months (face‐to‐face or telephone) 4) enhanced inter‐professional communication: CMs communicated the treatment plan to PCPs who discussed and amended as appropriate and discussions between CM and PCP preceded any further modifications. CM records were maintained in medical record. CMs attended monthly meetings and MH specialists were available for CMs when required Control: Treatment as usual enhanced as PCPs received training in current treatment strategies for depression and how to use brief diagnostic interview. Patient's diagnosis was placed in medical record |
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| Outcomes | Depression (BDI): 3, 12 months Medication use: 12 months Satisfaction: 3, 12 months |
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| Notes | AD: antidepressant; BDI: Beck Depression Inventory; CM: case manager; MH: mental health; PCP: primary care provider | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Coin‐toss |
| 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 (BDI) was: overall 22/268 (8%), 9/134 (7%) intervention and 13/134 (10%) control. Reasons for loss to follow‐up not provided by group. 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 |