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Implementation of Shared Decision Making Model in Psychiatric Rehabilitation Setting

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ClinicalTrials.gov Identifier: NCT01657708
Recruitment Status : Unknown
Verified August 2012 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Shared Decision Making With Patients Other: Shared Decision Making

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Shared Desicion Making Model Other: Shared Decision Making


Outcome Measures

Primary Outcome Measures :
  1. Adherence to psychiatric rehabilitation services [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657708


Contacts
Contact: Noa Patya, MD noapa@clalit.org.il
Contact: Yaara Zisman-Ilani, MA yaaraz@windowslive.com

Locations
Israel
Shalvata psychiatric hospital Not yet recruiting
Hod HaSharon, Israel
Contact: Noa Patyah, MD       noapa@clalit.org.il   
Sponsors and Collaborators
Shalvata Mental Health Center
More Information

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01657708     History of Changes
Other Study ID Numbers: SHA-0008-12
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012