Shared Decision Making for Patients With First-admission Schizophrenia

Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial

To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Shared Decision Making

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Shizuoka
    • Numazu, Shizuoka, Japan
      • Numazu Chuou Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admitted to an acute care psychiatric ward.
• Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
• Aged 16 to 65 years old at admission
• No prior experience of psychiatric admission (first-admission)

Exclusion Criteria:

• Diagnosed with moderate to severe mental retardation
• Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
• Having poor Japanese language skill
• Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision Making; The present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments.	Behavioral: Shared Decision Making; The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
No Intervention: Usual Care; Patients with no special program about decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)	Within 7days before the date of discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)	Within 7days before the date of discharge
Treatment continuation as measured by the rate of outpatient attendance during the 30 days	6 months after discharge

Collaborators and Investigators

• Sponsor: Yokohama City University
• Investigators: Study Chair: Yoshio Hirayasu, PhD, Department of Psychiatry, Yokohama City University School of Medical

Publications and helpful links

General Publications

• Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial. BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.
• Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial. BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: First hospitalization
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: SDMS-S