Routine Outcome Monitoring in Mental Health Outpatient

Anxiety Disorders Clinical Trial

— ROM-Shalvata  

Official title:

A Randomized Trial of Routine Computerized Outcome and Process Clinical Measures Monitoring in Mental Health Outpatient Services: Preparing for the Planned Public Mental Health Reform in Israel

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02095457
• Other study ID #: NIHP-R-161-2013
• Secondary ID: R-161-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 20, 2014
• Start date: July 2014

Study information

• Verified date: March 2014
• Source: Shalvata Mental Health Center
• Contact: Ori Ganor, MD
• Phone: 972-54-5454886
• Email: origa1[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Ministry of Health: Israel
• Study type: Interventional

Clinical Trial Summary

Scientific Background: Inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. Developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. The efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more.

Objectives: The aim of the current study is to test the feasibility and the clinical benefits of implementation of a Routine Outcome Monitoring System in a public clinical center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center.

Working Hypotheses: Incorporation of a ROM system in routine clinical practice is hypothesized to improve patients' and therapists' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures.

Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM) and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner.

Data Analysis: The evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using Multiple Analysis of Variance (MANOVA). The predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. The possible causal effects between specific lagged variables will be assessed using Hierarchical Linear Modeling and Time Series Analysis.

Contribution: This pioneering study is the first in Israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing intake to the clinic and beginning therapy

Exclusion Criteria:

• Mental retardation or dementia

• Hebrew Illiteracy

• Adults who are not under their own legal custody

• Not being able to fulfill the questionnaires with minor help

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Affective Disorders
• Anxiety Disorders
• Disease
• Mental Disorders
• Mood Disorders
• Personality Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Frequent monitoring and feedback
In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center Outpatient clinics	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	Overall clinical well-being as measured by the CORE-OM rating scale	The CORE-OM is a short questionnaire that addresses broad psychiatric symptoms including depression, anxiety, well-being, vocational and domestic functioning, social problems, etc.	up to 3 years follow-up	No
Secondary	Hospitalization rates		up to three years of follow-up	No

External Links

•   Shalvata Mental Health Center's homepage
•   The Israel National Institute for Health Policy homepage