Cole 2006.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Specialist setting and primary care Diagnosis: Major depression (as defined by DSM‐IV criteria) assessed using the Diagnostic Interview Schedule. Inclusion criteria: All patients aged 65 years and over admitted from the emergency department to medical services and scored 4 or less on the Short Portable Mental Status Questionnaire (indicating at most mild cognitive impairment) Exclusion criteria: Admitted to the intensive care unit or cardiac monitoring unit for more than 48 hours, had an imminently terminal illness, did not speak or understand English or French; and did not live on the Island of Montreal. Age: Mean 78 Gender: 69.4% female Ethnicity: Not stated Country: Canada Sample size (randomised): Total participants 157, intervention 78, control 79 |
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| Interventions | Treatment: Systematic detection and multidisciplinary care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Family physician (PCP), research nurse (CM), psychiatrist (MH specialist) 2) a structured management plan: (1) assessment and treatment by MH specialist in the hospital’s geriatric service; (2) follow‐up by the CM; and (3) follow‐up by the patient’s PCP. Treatment involved supportive psychotherapy and drug therapy with an AD, prescribed according to clinical practice guidelines. Contacts involved monitoring condition, providing supportive psychotherapy, ensuring maximum compliance with their treatment and liaising with the family, MH specialist and PCP 3) scheduled patient follow‐ups: Pre‐discharge: at least weekly. Post‐discharge: CM visited or telephoned weekly for 24 weeks 4) enhanced inter‐professional communication: CM liaised with PCP and MH specialist and updated MH specialist when patient followed up by PCP. Regular meetings between CM and MH specialist to assure consistency in diagnosis and management of depression Control: Treatment as usual enhanced as patients were advised of depression diagnosis and advised to inform PCP |
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| Outcomes | Depression (HAM‐D): 6 months Medication use: 6 months Quality of Life (mental and physical health): 6 months |
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| Notes | AD: antidepressant; CM: case manager; DSM‐IV: Diagnostic and Statistical Manual fourth edition; HAM‐D: Hamilton Depression Rating Scale; MH: mental health; PCP: primary care provider | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Block randomisation (size varied randomly) using 1:1 allocation ratio |
| Allocation concealment (selection bias) | Low risk | An individual not involved in patient recruitment prepared sealed envelopes allocated in order |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (≥ 50% decrease in HAMD) was: overall 93/157 (59%), 45/78 (58%) intervention and 48/79 (61%) control. Reasons for loss to follow‐up provided, with similar reasons for missing data across groups. Intention‐to‐treat analysis reported based on the assumption data is missing at random |
| 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 |