Bruce 2004.
Methods | Study design: Cluster‐randomised controlled trial | |
Participants | Setting: Primary care Diagnosis: All patients with a CES‐D score higher than 20 as well as a 5% random sample of patients with lower scores. Patients scoring 20 or lower and not selected randomly were recruited if they responded positively to supplemental questions about prior depressive episodes or treatment. Inclusion criteria: Age 60 years or older, ability to give informed consent, Mini‐Mental State Examination (MMSE) score of 18 or higher, and ability to communicate in English. Exclusion criteria: Not stated Age: Range 60 to 94 years Gender: 72% female Ethnicity: 67% white Country: United States Sample size (randomised): Total clusters 20, intervention 10, control 10; Total participants 598, intervention 320, control 278 |
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Interventions | Intervention: Primary care intervention Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: PCP, social workers, nurses, and psychologists (CM), psychiatrist (MH specialist) 2) a structured management plan: The Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) intervention had two major components (1) PCP worked with a clinical algorithm for treating geriatric depression in a primary care setting which recommended a first‐line trial of a SSRI (citalopram), (2) When a patient declined medication therapy, the PCP could recommend IPT from the CM. CMs monitored depressive symptoms, medication adverse effects, and treatment adherence. 3) scheduled patient follow‐ups: CM interacted with patients at scheduled intervals or when clinically necessary. 4) enhanced inter‐professional communication: Practice based CMs collaborated regularly with PCPs and received weekly supervision from MH specialist and additional monthly IPT supervision Usual care: Treatment as usual enhanced by educating PCPs about the treatment guidelines and notifying them when a patient met criteria for depression diagnosis. |
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Outcomes | Depression (BDI‐II): 3, 6, 12, 18, 24 months Medication use: 24 months Quality of Life (mental and physical health): 24 months |
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Notes | BDI: Beck Depression Inventory; CES‐D: Centre for Epidemiological Studies Depression; CM: case manager; IPT: interpersonal psychotherapy treatment; MH: mental health; PCP: primary care provider; SSRI: selective serotonin reuptake inhibitor | |
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 (HRSD) was: overall 122/598 (20%), 72/320 (23%) intervention and 50/278 (18%) 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 | Unclear risk | Insufficient information available to assess |