From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

Patients Diagnosed With Severe Mental Illness Clinical Trial

Official title:

Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00192751
• Other study ID #: compliance_CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 26, 2005
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: Rambam Health Care Campus
• Contact: Yael Caspi, Sc.D., M.A.
• Phone: +972-4-854-1987
• Email: y_caspi[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the benefit and impact on relapse prevention,adherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illness,recently discharged from inpatient services.

Description:

Medication non-compliance, estimated to affect 50% of all psychiatric patients, was shown to be strongly associated with an elevated risk for relapse, readmission to psychiatric inpatient care, longer length of stay and suicide, resulting in elevated costs across the health care system. The proposed project seeks to bridge the gap between the significant progress of recent years in psycho-pharmacology that produced more efficient ‘newer generation’ medications, and the continuing unanswered problem of non-compliance, by applying knowledge from clinical decision-making theories and recent evidence-based research on the management of severe mental illness.

In Phase I of the project, an epidemiological survey will be conducted to evaluate the magnitude and correlates of the problem in patients attending walk-in crisis clinic , using Treatment Compliance Assessment and Decision-Making Assessment Tools, both developed by the researchers. An 8-module psycho-educational intervention protocol emphasizing illness management and optimization of health care decision-making will then be designed and implemented.

In Phase II, eligible outpatient clients will be randomly assigned to either Intervention or Standard Care conditions, and followed for a period of 15 months. Repeated assessments will include pre-post measures of knowledge, treatment compliance, and decision-making, and on outcome measures of relapse such as hospitalizations and symptoms, functioning, self-efficacy, quality of life, and satisfaction with services.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the Rambam Medical Health Center.

Exclusion Criteria:

Diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Mental Disorders
• Patients Diagnosed With Severe Mental Illness

Intervention

Behavioral:
• Psychoeducational group sessions

Locations

Country	Name	City	State
Israel	Department of Psychiatry, Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse prevention
Primary	Illness management
Secondary	Satisfaction with care