Ell 2007.
Methods | Study design: Randomised controlled trial | |
Participants | Setting: Community Diagnosis: Screened positive for clinically significant depression Inclusion criteria: Home care, 65 and older Exclusion criteria: significant cognitive impairment, participation in another depression study Age: =Mean 78.1 years Gender: 73% female Ethnicity: 72% white Country: United States Sample size (randomised): Total participants 311, intervention 155, control 156 |
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Interventions | Treatment: Stepped care decision support Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), existing staff ‐ nurses, social workers, psychiatric nurses, a telephone case manager and a psychologist (CM), existing staff ‐ psychiatrist, nurses, social workers (MH specialist) 2) a structured management plan: A stepped care algorithm (based on IMPACT) in which patients were offered a choice of PST or ADs prescribed by PCP, or combined treatment if indicated. Step 1 (8‐10 weeks) choice of AD or PST. Patients with full response go to maintenance treatment. Step 2 (4‐8 weeks): if AD in step 1 and partial response give different AD type or augment AD, if no response PST. If PST in step 1 and partial response add AD or different AD type, if no response give AD. CMs monitored medication and delivered structured PST 3) scheduled patient follow‐ups: PST = 6‐12 sessions, medication = as per stepped care algorithm 4) enhanced inter‐professional communication: CM communicated with PCP about medication or if a patient did not improve. Usual supervisory staff had the responsibility of monitoring and supportive supervision Control: Treatment as usual was enhanced by routine depression screening and staff training in depression care management for older adults. Patients PCP informed if a patient screened positive for probable major or minor depression |
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Outcomes | Depression (PHQ‐9): 4, 8, 12 months Medication use: during study period Quality of Life (mental and physical health): 4, 8, 12 months |
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Notes | AD: antidepressant; CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire–9; PST: problem solving therapy | |
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 (PHQ‐9 50% reduction) was: overall 113/311 (36%), 58/156 (37%) intervention and 55/155 (35%) control. Reasons for loss to follow‐up not provided across groups. Intention‐to‐treat analysis reported using observed data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information available to assess |
Other bias | Unclear risk | Insufficient information available to assess |
Implementation Integrity | Low risk | Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes) |
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 |