NCT01657708

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. 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. 2.Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment Health J. 2006;42(1):87-105.
  3. 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. 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. 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. 6.Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health. Psychiatr Rehabil J. 2010;34(1):7-13.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 2, 2012

Last Update Submit

August 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to psychiatric rehabilitation services

    two years

Study Arms (1)

Shared Desicion Making Model

OTHER
Other: Shared Decision Making

Interventions

Shared Desicion Making Model

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults (over age 18), with severe mental illness signed an informed consent

You may not qualify if:

  • do not understand Hebrew did not sign an inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata psychiatric hospital

Hod HaSharon, Israel

Location

Central Study Contacts

Noa Patya, MD

CONTACT

Yaara Zisman-Ilani, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations