Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process
Primary Purpose
Serious Emotional Disturbance of Youth
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wraparound Team Monitoring System electronic health record
Education about fidelity maintenance and monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Serious Emotional Disturbance of Youth focused on measuring Patient care team, Care management, Electronic health records
Eligibility Criteria
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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Use of electronic health record / outcomes monitoring
education about outcomes monitoring
Arm Description
Use of electronic health record / outcomes monitoring via a specified electronic behavioral health information system
Care coordination as usual with education about fidelity and outcomes monitoring but no use of EBHIS
Outcomes
Primary Outcome Measures
more effective teamwork (Team Climate Inventory (TCI)
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
treatment alliance (Working Alliance Inventory (WAI)
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
improved youth functioning (Top Problem Assessment (TPA)
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.
Secondary Outcome Measures
parent and provider satisfaction (Parent and Child Satisfaction Scales)
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
attitudes toward standardized assessment (Attitudes toward Standardized Assessment Scale (ASA)105)
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.
Full Information
NCT ID
NCT02421874
First Posted
April 10, 2015
Last Updated
October 24, 2016
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02421874
Brief Title
Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process
Official Title
Development, Usability Testing, and Effectiveness Evaluation of Wraparound Team Monitoring System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Emotional Disturbance of Youth
Keywords
Patient care team, Care management, Electronic health records
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of electronic health record / outcomes monitoring
Arm Type
Experimental
Arm Description
Use of electronic health record / outcomes monitoring via a specified electronic behavioral health information system
Arm Title
education about outcomes monitoring
Arm Type
Active Comparator
Arm Description
Care coordination as usual with education about fidelity and outcomes monitoring but no use of EBHIS
Intervention Type
Behavioral
Intervention Name(s)
Wraparound Team Monitoring System electronic health record
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Education about fidelity maintenance and monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
more effective teamwork (Team Climate Inventory (TCI)
Description
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
Time Frame
6 months
Title
treatment alliance (Working Alliance Inventory (WAI)
Description
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
Time Frame
6 months
Title
improved youth functioning (Top Problem Assessment (TPA)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
parent and provider satisfaction (Parent and Child Satisfaction Scales)
Description
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
Time Frame
3 months
Title
attitudes toward standardized assessment (Attitudes toward Standardized Assessment Scale (ASA)105)
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Bruns, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29903701
Citation
Bruns EJ, Hook AN, Parker EM, Esposito I, Sather A, Parigoris RM, Lyon AR, Hyde KL. Impact of a Web-Based Electronic Health Record on Behavioral Health Service Delivery for Children and Adolescents: Randomized Controlled Trial. J Med Internet Res. 2018 Jun 14;20(6):e10197. doi: 10.2196/10197.
Results Reference
derived
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Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process
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