Implementation of Shared Decision Making Model in Psychiatric Rehabilitation Setting

Shared Decision Making With Patients Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01657708
• Other study ID #: SHA-0008-12
• Status: Not yet recruiting
• Phase: N/A
• First received: August 2, 2012
• Last updated: August 2, 2012
• Start date: August 2012

Study information

• Verified date: August 2012
• Source: Shalvata Mental Health Center
• Contact: Noa Patya, MD
• Email: noapa[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Ministry of Health: Israel
• Study type: Interventional

Clinical Trial Summary

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

1. 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.

2. Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment Health J. 2006;42(1):87-105.

3. 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.

4. 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.

5. 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.

6. Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health. Psychiatr Rehabil J. 2010;34(1):7-13.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Shared Decision Making With Patients

Intervention

Other:
• Shared Decision Making

Locations

Country	Name	City	State
Israel	Shalvata psychiatric hospital	Hod HaSharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to psychiatric rehabilitation services		two years	No