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

Abstract

BackgroundSevere 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/DesignThis 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.DiscussionThis 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 registrationIRCT201009052557N2

Cost-effectiveness of aftercare services for people with severe mental disorders: an analysis parallel to a randomised controlled clinical trial in Iran

“…The study protocol was published previously and contains details about the intervention and study design (Hajebi et al . , Vasfi et al . ); here, we present a summary of methods.…”

“…Institutional review board (IRB) of Tehran University of Medical Sciences approved the trial (Ethics Committee reference: 130-6-2441). The study protocol was published previously and contains details about the intervention and study design (Hajebi et al 2013b, Vasfi et al 2015; here, we present a summary of methods. The study population included people with severe mental disorders (including schizophrenia, schizoaffective disorder or bipolar disorder) who were hospitalised at Psychiatric Center of Iran.…”

Efficacy of Aftercare Services for People With Severe Mental Disorders in Iran: A Randomized Controlled Trial

“…Patients who did not sign an informed consent agreement were excluded from the study and received treatment as usual. A detailed description of the methodology of this study can be found in the study protocol paper (37).…”

“…Before entering the study, patients and their family members were informed about the study conditions and processes, and written informed consent was obtained from them and their guardians (37). Our study design was approved by the Ethics Committee of Tehran University of Medical Sciences (#130-6-2441) and was in complete agreement with the 2008 Declaration of Helsinki.…”

“…We also tested the hypothesis that patients who received aftercare services would have reduced length of hospital stay. Findings of this study are part of a larger multicenter project evaluating the efficacy and costeffectiveness of aftercare services and their impact on different measures of patients' outcomes during a 12-month follow-up period (37). In this study, the follow-up period was extended to 20 months.…”