- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657708
Implementation of Shared Decision Making Model in Psychiatric Rehabilitation Setting
Background:
Shared Decision Making (SDM) refers to a process of health care delivery in which practitioners and clients seeking help with decisions, collaborate to access relevant information and enable client-centered selections of health care resources (1, 2). SDM leads to better treatment adherence and outcomes for people with a medical problem (3). SDM principles have previously been used in psychiatry to improve antipsychotic and antidepressant medication adherence (4, 5); however, these principles have yet to be applied to psychiatric rehabilitation (6).
The current research uniquely aims to test the development and implementation of a SDM intervention for people with psychotic spectrum disorders (e.g., schizophrenia and affective disorder) during the referral process to psychiatric rehabilitation services. The study will be conducted this year using a randomly selected sample from the population of people with psychotic spectrum disorders hospitalized in SHALVATA psychiatric hospital in Israel. It aims to facilitate better treatment and rehabilitation outcomes. It has received the support and approval of the Mental Health Division of the Ministry of Health (MOH) in Israel, the institutional review board (IRB) by the university of Haifa, Israel and a Helsinki committee approval by SHALVATA psychiatric hospital and the MOH in Israel.
References
- Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does it mean?(or it takes at least two to tango). Soc Sci Med. 1997;44(5):681-92.
- Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment Health J. 2006;42(1):87-105.
- Joosten EAG, DeFuentes-Merillas L, De Weert GH, Sensky T, Van Der Staak, C. P. F., De Jong, C. A. J. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77(4):219-26.
- Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish to be involved in decisions about their medical treatment? Am J Psychiatry. 2005;162(12):2382.
- Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision making for in-patients with schizophrenia. Acta Psychiatr Scand. 2006;114(4):265-73.
- Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health. Psychiatr Rehabil J. 2010;34(1):7-13.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hod HaSharon, Israel
- Shalvata psychiatric hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults (over age 18), with severe mental illness signed an informed consent
Exclusion Criteria:
- do not understand Hebrew did not sign an inform consent
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Shared Desicion Making Model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adherence to psychiatric rehabilitation services
Time Frame: two years
|
two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHA-0008-12
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