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Open Access Study protocol

Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial

Mio Ishii123*, Yasuyuki Okumura34, Naoya Sugiyama2, Hana Hasegawa2, Toshie Noda23, Yoshio Hirayasu2 and Hiroto Ito3

Author Affiliations

1 Department of Psychiatry, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan

2 Numazu Chuo Hospital, 24-1 Nakase-cho, Numazu, Shizuoka 410-8575, Japan

3 Department of Social Psychiatry, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan

4 Research Department, Institute for Health Economics and Policy, Association for Health Economics Research and Social Insurance and Welfare, 1-5-11 Nishishimbashi, Minato-ku, Tokyo 105-0003, Japan

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BMC Psychiatry 2014, 14:111  doi:10.1186/1471-244X-14-111

Published: 14 April 2014

Abstract

Background

Shared decision making is a promising model for patient-centred medicine, resulting in better clinical outcomes overall. In the mental health field, interventions that consider the patient-centred perspective—such as patient quality of life, involvement in the treatment, treatment satisfaction, and working alliance—have increased and better clinical outcomes discovered for patients with schizophrenia. However, few studies have examined the efficacy of shared decision making for schizophrenia treatment. The objective of this study is to evaluate the effect of a shared decision making intervention compared to treatment as usual on patient satisfaction at discharge for first-admission patients with schizophrenia.

Methods/Design

This is a randomised, parallel-group, two-arm, open-label, single-centre study currently being conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. We are recruiting patients between 16 and 65 years old who are admitted to the ward with a diagnosis of schizophrenia without prior experience of psychiatric admission. Fifty-eight participants are being randomised into a shared decision making intervention group or a treatment as usual control group in a 1:1 ratio. The intervention program was developed based on a shared decision making model and is presented as a weekly course lasting the duration of the patients’ acute psychiatric ward stay. The primary outcome measure is patient satisfaction at discharge as assessed by the Client Satisfaction Questionnaire. Due to the study’s nature, neither the patient nor staff can be blinded.

Discussion

This is the first randomised controlled trial to evaluate the efficacy of shared decision making for patients with early-treatment-stage schizophrenia. The intervention program in this study is innovative in that it includes both of the patient and staff who are involved in the treatment.

Trial registration

The study has been registered with ClinicalTrials.gov as NCT01869660.

Keywords:
Schizophrenia; Shared decision making; Patient satisfaction; Randomised controlled trial; Study protocol