Rollman 2009.
| Methods | Study design: Randomised controlled trial | |
| Participants | Setting: Specialist, primary care Diagnosis: PHQ‐9 scores of 10 or greater confirmed the prior PHQ‐2 screen results and indicated at least a moderate level of depressive symptoms Inclusion criteria: Post‐CABG (Coronary Artery Bypass Graft) patients, mental competence to provide consent, have no current alcohol dependence or other substance abuse disorder; not be in treatment with a mental health specialist, express actives suicidality, or have a history of psychotic illness or bipolar disorder, be discharged home or to short‐term rehabilitation; and to speak English, have no communication barriers, and have telephone access Exclusion criteria: Not stated Age: Mean 64 years Gender: 61% female Ethnicity: 91% white Country: United States Sample size (randomised): Total participants 302, intervention 150, control 152 |
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| Interventions | Intervention: Telephone collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), nurse (CM), psychiatrist (MH specialist) 2) a structured management plan: CM conducted telephone assessment, provided basic education about depression (its impact on cardiac disease, and various self‐management strategies) and assessed treatment preferences. Patients were supplied with written educational materials and offered a variety of treatment options: (1) initiation or adjustment of AD; (2) referral to community mental health service; (3) a combination of the above; or (4) watchful‐waiting. CMs advised all patients to: (1) get sufficient rest; (2) engage in appropriate exercise and other pleasurable activities; and (3) avoid tobacco, alcohol, and unhealthy foods. CMs sent out a workbook that integrated both a psychotherapeutic and pharmacologic approach to managing depression and worked with patients and PCPs to promote adherence. For non‐adherence or non‐response after 6 weeks, combined treatment was recommended. For continued non‐response CMs recommended referral to MH services and CMs monitored attendance and continued to telephone the patient monthly to: (1) monitor mood; (2) relay clinical information to PCP and MH specialist; and (3) promote adherence with follow‐up appointments. 3) scheduled patient follow‐ups: Acute=4‐8 telephone calls (fortnightly for 2‐4 months), maintenance = 4‐8 (every 1 to 2 months until end of 8 month) 4) enhanced inter‐professional communication: CM reported back to the PCP clinical progress, reasons for non‐adherence and treatment recommendations via fax, telephone or mail after each case review with MH specialist. CMs discussed AD prescriptions with PCP. An end‐of‐intervention letter was sent to PCP describing current level of depressive symptoms, care preferences, and final treatment recommendations. CMs had weekly case review with MH specialist Control: Treatment as usual enhanced as patients and PCPs were informed of diagnosis |
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| Outcomes | Depression (HRSD): 2, 4, 8 months Medication use: 2, 4, 8 months Quality of Life (mental and physical health): 2, 4, 8 months |
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| Notes | CM: case manager; HRSD: Hamilton Rating Scale for Depression; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated in blocks of 4 using a 1:1 allocation ratio |
| Allocation concealment (selection bias) | Low risk | Prepared by an individual not involved in patient recruitment and entered into computer assisted programme and concealed until after the patient was recruited |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (≥ 50% decline in HRSD) was: overall 50/302 (17%), 24/150 (16%) intervention and 26/152 (17%) 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 |