Fortney 2007.
| Methods | Study design: Cluster‐randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Screened positive for depression, defined as a PHQ‐9 score ≥ 12 Inclusion criteria: Veterans Exclusion criteria: Diagnosis of schizophrenia, current suicidal ideation, recent bereavement, pregnancy, a court‐appointed guardian, substance dependence, bipolar disorder, cognitive impairment, or receiving specialty mental health treatment Age: Mean 59.2 (SD 12.2) years Gender: 8% female Ethnicity: 75% white Country: United States Sample size (randomised): Total clusters 7, intervention 3, control 4; Total participants 395, intervention 177, control 218 |
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| Interventions | Intervention: Stepped care Telemedicine Enhanced Antidepressant Management (TEAM) Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), nurse supported by pharmacist (CM), psychiatrist (MH specialist) 2) a structured management plan: stepped‐care model including: Step (1) choice of either watchful waiting or AD. CM encounters were conducted via telephone and were scripted and administered using software package. During the initial care management encounter, patients were: (1) clinically assessed; (2) educated and activated; and 3) assessed for treatment barriers. Follow‐up encounters monitored symptoms, medication adherence, and side‐effects. Step (2) If the patient did not respond to the initial AD, the pharmacist conducted a medication history and provided pharmacotherapy recommendations to PCPs via an electronic progress note. The pharmacist also provided non‐scripted medication management over the phone to patients experiencing severe side‐effects or problems with non‐adherence. Step (3) If the patient did not respond to 2 AD trials, the protocol was to recommend a telepsychiatry consultation followed by additional treatment recommendations to the PCP 3) scheduled patient follow‐ups: Acute = Telephone calls scheduled every 2 weeks Watchful waiting or continuation = every 4 weeks 4) enhanced inter‐professional communication: All feedback was provided to PCPs using the electronic medical record. Progress notes reporting failed trials requested an electronic co‐signature from the PCP. CM had weekly supervision with MH specialist and pharmacist. Telepsychiatry consultation was followed by additional treatment recommendations to the PCP Control: Treatment as usual enhanced as provider education (via interactive video and website) and patient education (via mail and website) were provided. Depression screening results were entered into the electronic medical record |
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| Outcomes | Depression (HSCL‐20): 6, 12 months Medication use: 6, 12 months Quality of Life (mental and physical health): 6, 12 months Satisfaction: 6, 12 months |
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| Notes | CM: case manager; HSCL: Hopkins Sympton Checklist; MH: mental health; PCP: primary care provider: PHQ‐9: Patient Health Questionnaire; SD: standard deviation | |
| 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 (Response HSCL‐20 50% improvement) was: overall 35/395 (9%), 17/177 (10%) intervention and 18/218 (8%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. 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 | Low risk | Assessor was not aware of treatment allocation |