Shared Decision Making for Patients With First-admission Schizophrenia

NCT01869660 | Completed Phase 2

• 1 other identifier: SDMS-S
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

First hospitalization

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)

  Within 7days before the date of discharge

Secondary Outcomes (2)

• 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

Study Arms (2)

Shared Decision Making

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Patients with no special program about decision making.

Interventions

Shared Decision Making BEHAVIORAL

The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.

Shared Decision Making

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yokohama City University: lead

Study Sites (1)

Numazu Chuou Hospital

Numazu, Shizuoka, Japan

Location

Related Publications (2)

• 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.

  PMID: 28166757 DERIVED

• 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.

  PMID: 24725910 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Yoshio Hirayasu, PhD

  Department of Psychiatry, Yokohama City University School of Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-08

Locations

JP (1)