Bogner 2010.
| Methods | Study design: Pilot randomised controlled trial | |
| Participants | Setting: Primary Care Diagnosis: A diagnosis of depression or a prescription for an antidepressant within the past year Inclusion criteria: Diabetics aged 50 and older, an A1C > 7 at their last primary care office visit or a prescription for an oral hypoglycaemic agent within the past year, older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice Exclusion criteria: Not stated Age: Mean 60 years Gender: 85% female Ethnicity: 100% African American Country: United States Sample size (randomised): Total participants 58, intervention 29, control 29 |
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| Interventions | Intervention: Integrated care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Family physician (PCP), research co‐ordinator (CM), academic PCP (MH specialist) 2) a structured management plan: Intervention focused on depression in the context of type 2 diabetes mellitus and aimed to promote patients’ adherence to an oral hypoglycaemic agent and AD. CM collaborated with PCP to help participants understand and recognise depression in the context of type 2 diabetes mellitus, offered guideline‐based treatment recommendations, monitored adherence and clinical status, assessment for the presence of side effects and assistance in their management, and provided appropriate follow‐up or referral. Individualised programme congruent with patients’ social and cultural context 3) scheduled patient follow‐ups: 3 face‐to‐face, 2 phone contacts in 4‐week period 4) enhanced inter‐professional communication: CM acted as liaison between PCP and the elderly depressed patient with type 2 diabetes mellitus in promoting adherence to medication. CM received weekly supervision from specialist Control: Treatment as usual |
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| Outcomes | Depression (CES‐D): 12 weeks Medication use: 2, 4, 6, 12 weeks |
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| Notes | AD: antidepressant; CES‐D: Centre for Epidemiological Studies Depression; 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) | Unclear risk | Insufficient information available to assess |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (CES‐D) was: overall 0/58 (0%), 0/29 (0%) intervention and 0/29 (0%) control. Intention‐to‐treat analysis not reported |
| 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 |