- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421874
Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process
Development, Usability Testing, and Effectiveness Evaluation of Wraparound Team Monitoring System
The purpose of this Phase II Small Business Technology Transfer (STTR) project is to complete development and evaluate usability and effectiveness of the Wraparound Team Monitoring System (Wrap-TMS), a web-based, electronic behavioral health information system (EBHIS) for the most widely implemented care coordination model in children's behavioral health, the wraparound process. Though wraparound is now considered "evidence-based," implementation in the real world often fails to conform to standards of fidelity and/or use objective data to guide management, supervision, and clinical decision making. Availability of such a system will support efficiency, implementation quality and fidelity, and outcomes for youths enrolled in wraparound. Wrap-TMS features functionality for data entry, management, and basic reporting for the full array of data and information elements needed to manage an integrated care coordination initiative for youths with serious emotional and behavioral disorder (SEBD). In light of our success in Phase I, subsequent partnerships with federal agencies, and inquiries of interest from several states and over 20 provider and managed care organizations, in this Phase II STTR the investigators will complete development of Wrap-TMS, followed by a randomized controlled effectiveness study comparing n=25 wraparound facilitators who use Wrap-TMS serving n=100 families to 25 non-user facilitators serving 100 families on practitioner, implementation, and youth/family outcomes. The evaluation will test two primary hypotheses:
- Compared to facilitators in the control group, wraparound facilitators trained to use Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b) greater fidelity to the wraparound process; (c) higher self-reported teamwork, working alliance, and satisfaction with the intervention; and (d) more positive attitudes toward standardized assessment.
- Compared to the control group, parents of youths receiving services from facilitators trained to use TMS will report (a) greater goal clarity, (b) more data collection and use (c) greater satisfaction with services and progress, (d) better fidelity to wraparound, (e) more effective team functioning, (f) greater treatment alliance, and (f) better youth outcomes including greater progress and improved symptoms and functioning.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98102
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent or legal guardian of a youth aged 6-17 with SEBD (serious emotional and behavioral disorder): at least one MH (mental health) diagnosis that results in long-term (>6 mos) impairment in home, school and/or community functioning).
Exclusion Criteria:
- Non English speaking parents
- Foster parents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Use of electronic health record / outcomes monitoring
Use of electronic health record / outcomes monitoring via a specified electronic behavioral health information system
|
Wraparound Team Monitoring System (Wrap-TMS) is a web-based, electronic behavioral health information system (EBHIS) for the most widely implemented care coordination model in children's behavioral health, the wraparound process
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Active Comparator: education about outcomes monitoring
Care coordination as usual with education about fidelity and outcomes monitoring but no use of EBHIS
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As an active comparator, we will educate practitioners randomized to the control condition about the importance of maintaining fidelity and monitoring fidelity and progress via a 3 hour training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
more effective teamwork (Team Climate Inventory (TCI)
Time Frame: 6 months
|
Team Climate Inventory (TCI).
The TCI is a 38-item survey that evaluates five relevant aspects of health care teamwork (Shared Vision, Participation safety, Support for Innovation, Task orientation, Interaction frequency) using a 5 point Likert scale.
Assessed at 4 mos.
post enrollment
|
6 months
|
treatment alliance (Working Alliance Inventory (WAI)
Time Frame: 6 months
|
Working Alliance Inventory (WAI) is a widely used rating scale designed to measure the working alliance between counselors and clients.
Assessed at 4 mos.
post enrollment
|
6 months
|
improved youth functioning (Top Problem Assessment (TPA)
Time Frame: 6 months
|
Top Problem Assessment (TPA) is a consumer-focused index the severity of the top three problems nominated by the parent, on a scale of 0-10.
Assessed at BL, 1, 2, 3, 4 mos.
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
parent and provider satisfaction (Parent and Child Satisfaction Scales)
Time Frame: 3 months
|
Parent and Child Satisfaction Scales reliably measure five dimensions of satisfaction, each with 1 Likert scale item, including: (1) access and convenience, (2) child's treatment process and relationship with providers, (3) parent and family services, satisfaction with progress, and (5) global satisfaction.
Assessed at 4 mos post enrollment
|
3 months
|
attitudes toward standardized assessment (Attitudes toward Standardized Assessment Scale (ASA)105)
Time Frame: 3 months
|
Attitudes toward Standardized Assessment Scale (ASA)105.
A 22-item measure of clinician perceptions and attitudes about using standardized assessments in their clinical practice.
Items are scored on a 1 (Strongly Disagree) to 5 (Strongly Agree) scale and yield 3 subscales with adequate or better reliabilities: Benefit over Clinical Judgment, Psychometric Quality, and Practicality.
Administered to practitioners at baseline and 4 mos.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric J Bruns, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R42MH095516 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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