Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
900 participants
INTERVENTIONAL
2014-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Infrequent monitoring without feedback
In the control arm, patients will infrequently fill short monitoring questionnaires, the results of which are not fed back to their therapists and staff. The frequency of monitoring is between about once a year
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hebrew Illiteracy
* Adults who are not under their own legal custody
* Not being able to fulfill the questionnaires with minor help
6 Years
ALL
No
Sponsors
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Shalvata Mental Health Center
OTHER
Responsible Party
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Ori Ganor
Ori Ganor, MD
Locations
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Shalvata Mental Health Center Outpatient clinics
Hod HaSharon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-161-2013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NIHP-R-161-2013
Identifier Type: -
Identifier Source: org_study_id
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