Department of Psychiatry, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.
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.
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.
The study has been registered with ClinicalTrials.gov as NCT01869660.
共同决策是一种以患者为中心的医学模式，总体上能带来更好的临床结果。在精神卫生领域，考虑到以患者为中心的干预措施，如患者的生活质量、参与治疗、治疗满意度和工作联盟，已经增加了，并且发现精神分裂症患者的临床结果更好。然而，很少有研究检验共同决策对精神分裂症治疗的疗效。本研究的目的是评估与常规治疗相比，共同决策干预对首次入院精神分裂症患者出院时患者满意度的影响。
方法/设计：这是一项正在日本沼津中央医院的急性精神病房进行的随机、平行组、双臂、开放标签、单中心研究。我们正在招募年龄在 16 至 65 岁之间、因首次入院而被诊断为精神分裂症且无先前入院精神科经历的患者。58 名参与者按 1:1 的比例随机分配到共同决策干预组或常规治疗对照组。干预方案是基于共同决策模型制定的，作为每周一次的课程，持续患者在急性精神病房的住院时间。主要结局指标是通过患者满意度问卷评估的出院时患者满意度。由于研究的性质，患者和工作人员都无法被蒙蔽。
这是第一项评估早期治疗阶段精神分裂症患者共同决策疗效的随机对照试验。本研究中的干预方案具有创新性，因为它包括了参与治疗的患者和工作人员。
该研究已在 ClinicalTrials.gov 上注册，编号为 NCT01869660。
