Capoccia 2004.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: A new episode of depression and started on an antidepressant medication. Depression assessed using the Primary Care Evaluation of Mental Disorders (PRIME‐MD) Inclusion criteria: Diagnosed with a new episode of depression (PRIME‐MD) and started on an antidepressant medication. Exclusion criteria: Age of < 18 years, terminal illness, psychosis, recent (within the past 3 months) alcohol (AUDIT score of > 8) or substance abuse, two or more suicide attempts, pregnancy or nursing, limited command of the English language, and unwillingness to use the University of Washington Family Medical Centre as a source of care for the next 12 months Age: Mean 38.7 (SD 13.5) years Gender: 77% female Ethnicity: 78% white Country: United States Sample size (randomised): Total participants 74, intervention 41, control 33 |
|
| Interventions | Intervention: Enhanced care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: PCP, pharmacist (CM), study psychiatrist (MH specialist) 2) a structured management plan: CMs addressed depressive symptoms and medication‐related concerns. The initial contacts focused on support and education, as well as medication dosage adjustment and the management of adverse effects including change or discontinuation of ADs, and provision of additional pharmacotherapy for insomnia or sexual dysfunction, as needed. Appointments with mental health providers were also facilitated. 3) scheduled patient follow‐ups: 13 contacts during 12 month period. Weekly telephone calls for the first four weeks, followed by phone contact every two weeks through week 12. During months 4–12, the subjects received a telephone call every other month. 4) enhanced inter‐professional communication: PCPs were informed of medication changes made by CM and shared computerised medical records used. On a bi‐monthly basis, the CM and MH specialist reviewed individual cases. Patients were referred to PCP and/or psychiatrist if suicidal ideation detected (also to psychiatrist if no symptom improvement) Control: Treatment as usual enhanced as case managers assessed patients and patients encouraged to use available resources |
|
| Outcomes | Depression (HSCL‐20): 3, 6, 9, 12 months Medication use: 3, 6, 9, 12 months Satisfaction: 3, 6, 9, 12 months |
|
| Notes | AD: antidepressant; CM: case manager; HSCL: Hopkins Sympton Checklist; MH: mental health; PCP: primary care provider | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| 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 (HSCL‐20 > 50%) was: overall 4/74 (5%), 2/41 (5%) intervention and 2/33 (6%) 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 | High risk | Case managers had some contact with patients in the control group |
| 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 |