A multicenter randomized controlled trial of aftercare services for severe mental illness: study protocol.

BACKGROUND: Severe mental illness is responsible for a significant proportion of burden of diseases in Iranian population. People with severe mental illnesses are more likely to have high rates of non-attendance at follow-up visits, and lack of an active follow-up system, particularly in the country's urban areas that has resulted in the revolving door phenomenon of rehospitalizations. Therefore, there is an increasing need for implementation of effective and cost-effective aftercare services. METHOD/DESIGN: This is a randomized control trial with the primary hypothesis that aftercare services delivered to patients with severe mental illnesses in outpatient department and patient's home by a community care team would be more effective when compared to treatment as usual (TAU) in reducing length of hospital stay and any psychiatric hospitalization. Patients were recruited from three psychiatric hospitals in Iran. After obtaining informed written consent, they were randomly allocated into aftercare intervention and control (TAU) groups. Aftercare services included treatment follow-up (through either home care or telephone follow-up prompts for outpatient attendance), family psychoeducation, and patient social skills training that were provided by community mental health teams. Patients were followed for 12 months after discharge. The primary outcome measures were length of hospital stay and any hospitalization in the 12 month follow-up. Secondary outcome measures included patients' clinical global impression, global functioning, quality of life, and patient's satisfaction. The trial also allowed an assessment of direct cost-effectiveness of the aftercare services. DISCUSSION: This paper presents a protocol for an RCT of aftercare services delivered to patients with severe mental illnesses within patients' home or outpatient department. The findings of this study can influence policy and program planning for people with severe mental illnesses in Iran. TRIAL REGISTRATION: IRCT201009052557N2.