Pyne 2011.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Specialist Diagnosis: PHQ‐9 depression score of 10 or higher Inclusion criteria: Current treatment in the Veteran Affairs HIV clinic Exclusion criteria: No access to a telephone, current acute suicidal ideation, significant cognitive impairment and history of bipolar disorder or schizophrenia Age: Mean 49.8 years Gender: 3% female Ethnicity: 63% African American Country: United States Sample size (randomised): Total participants 276 (249), intervention 138 (123), control 138 (126) |
|
| Interventions | Intervention: Stepped care (HITIDES) Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: HIV or mental health clinician (PCP), nurse (CM), pharmacist/psychiatrist (MH specialist) 2) a structured management plan: CMs, using written scripts, delivered education and activation, assessment of treatment barriers and solutions, depression and substance abuse monitoring, and instruction in self‐management. The 5‐step model included the following plus CM monitoring: (1) watchful waiting, (2) counselling or guideline pharmacotherapy, (3) review by pharmacist, (4) combination pharmacotherapy and counselling, and (5) referral to specialty mental health. 3) scheduled patient follow‐ups: depended on response. Acute = every 2 weeks (until 50% reduction in depression score), watchful waiting or continuation = every 4 weeks (for 2 months after maintaining remission or 6 months after maintaining a 50% decrease in depression score) 4) enhanced inter‐professional communication: CMs communicated with PCPs via electronic medical record progress notes. CMs communicated with MH specialist once a week and as needed by telephone or in‐person and made treatment recommendations to PCPs Control: Treatment as usual enhanced as all HIV health care providers received 1 hour of HIV and depression training and were informed of depression scores. Specialty mental health referral procedures were reviewed |
|
| Outcomes | Depression (HSCL‐20): 6, 12 months Medication use: 6, 12 months Quality of Life (mental and physical health): 6, 12 months |
|
| Notes | CM: case manager; HSCL: Hopkins Symptom Checklist; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | Envelopes labelled by patient number |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL‐20 response 50% decrease) was: overall 50/276 (18%), 29/138 (21%) intervention and 21/138 (15%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. Used intention‐to‐treat analysis |
| 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 |