Finley 2003.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Depressive symptoms and just commenced antidepressant therapy to treat this Inclusion criteria: Not stated Exclusion criteria: Evidence that subjects had received an antidepressant during the preceding 6 months; concurrent psychiatric or psychological treatment; current symptoms of mania or bipolar disorder; psychotic symptoms; eminent suicidality; and active substance abuse or dependence. If psychiatric treatment was indicated at baseline or any time during the investigation, subjects were referred to the HMO's psychiatry department for care (or were permitted to self‐refer) and subsequently were excluded from further study participation. Age: Mean 54.3 years Gender: 85% female Ethnicity: Not stated Country: United States Sample size (randomised): Total participants 125, intervention 75, control 50 |
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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), pharmacist (CM), psychiatrist (MH specialist) 2) a structured management plan: Assessment of severity of psychopathology, potential stressors and other predisposing factors and patient education was provided. Information on depression and the role of ADs was presented (including potential therapeutic effects/adverse effects). Patients were advised of other treatment options and resources available. CMs were permitted to titrate ADs consistent with clinical practice guidelines. CMs could also prescribe ancillary drugs but if a change in AD drugs was indicated, approval from the PCP was required. As patients improved CMs identified neglected activities and encouraged patients to resume them. Patients were advised to contact the clinic if they were considering the discontinuation of antidepressants at any time in the future. 3) scheduled patient follow‐ups: Assessment plus 5 telephone calls at key junctures in recovery process and 2 clinic visits at 6 and 24 weeks. 4) enhanced inter‐professional communication: All contacts were recorded in the medical record in the form of a detailed progress note. CM discussed with PCP by phone or messaging system any need for change to ADs. At the end of treatment a comprehensive summary of the treatment course and patient disposition was entered into records. Weekly case conferences with CMs and MH specialist clarified diagnostic issues and more clearly delineate treatment plans. MH specialists were also available for off‐site telephone consultation on an as‐needed basis for more pertinent issues Control: Treatment as usual including brief information on the AD, therapeutic end points, and side effects in a manner consistent with patient education routinely delivered by the pharmacy. The referring PCP was notified of assignment and subsequent treatment and follow‐up were left to the provider's discretion |
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| Outcomes | Depression (BIDS): 6 months Medication use: 114 days, 231 days, 3, 6, months Satisfaction: 6 months |
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| Notes | AD: antidepressant; CM: case manager; 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) | Low risk | Sealed envelope |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (Percentage with 50% reduction) was: overall 47/125 (38%), 21/75 (28%) intervention and 26/50 (52%) control. Reasons for loss to follow‐up not reported Intention‐to‐treat analysis reported, no description of methods to manage missing data |
| 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 | Unclear risk | Insufficient information available to assess |