- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05370157
TeamTRACS Pilot (CTSI)
April 22, 2024 updated by: Elizabeth McGuier, University of Pittsburgh
Improving Teamwork in Rural Child Advocacy Centers: A Hybrid-Effectiveness Implementation Trial of TeamTRACS
In a previous research study, the investigators adapted an evidence-based team training intervention for healthcare settings (TeamSTEPPS) to fit the needs and context of Child Advocacy Center multidisciplinary teams.
This study is a cluster-randomized controlled trial of the adapted training, TeamTRACS (Team Training in Roles, Awareness, Communication, and Support).
This hybrid type 2 effectiveness-implementation study will test the effectiveness of TeamTRACS and pilot a self-guided approach to implementing TeamTRACS in low-resource settings.
Study Overview
Detailed Description
This study is designed to test the effects of TeamTRACS on knowledge, skill use, and team functioning.
It will also evaluate the acceptability, appropriateness, and feasibility of a self-guided implementation approach that requires few resources and builds local capacity for change.
Six rural Child Advocacy Centers (CACs) will be randomized to TeamTRACS (4 CACs) or a waitlist comparison (2 CACs).
The long-term goal of this research is to create an effective team training that can be rapidly scaled up and disseminated to rural CACs nationwide.
Supporting rural teams can improve team performance, strengthen the workforce, and ultimately improve service quality and outcomes for rural children who experience child abuse.
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.
Exclusion Criteria:
- Under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)
CACs randomized to the intervention condition (n = 4) will participate in TeamTRACS.
CACs will receive an implementation guide to assist in preparing for and maximizing the impact of training.
|
TeamTRACS is a team training intervention adapted from TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety), a widely used evidence-based team training developed by the Agency for Healthcare Research and Quality.
TeamTRACS targets knowledge, skills, and attitudes related to team member roles, shared awareness, communication, mutual support, and goal-setting.
TeamTRACS is structured, easy to use, flexible in length and intensity, and requires few resources.
It incorporates didactic instruction, discussion, and interactive activities and can be delivered virtually or in-person.
|
|
No Intervention: Waitlist Comparison
CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Teamwork Knowledge From Baseline to 3-month Follow-up
Time Frame: Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
Survey questions assessing knowledge taught in TeamTRACS will be assessed with multiple choice questions.
The percent of correct answers (range 0-100%) will be calculated.
|
Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
|
Change in Teamwork Skill Use From Baseline to 3-month Follow-up
Time Frame: Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
Frequency of teamwork skill use will be assessed with survey items rated on a 5-point Likert scale (range 1-5).
Scores will be averaged; higher scores indicate more frequent skill use.
|
Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
|
Acceptability of Self-guided Implementation
Time Frame: Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
|
Perceived acceptability of the self-guided implementation process will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions.
|
Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
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Appropriateness of Self-guided Implementation
Time Frame: Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
|
Perceived appropriateness of the self-guided implementation process will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions.
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Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
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Feasibility of Self-guided Implementation
Time Frame: Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
|
Perceived feasibility of the self-guided implementation process will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions.
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Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Team Functioning From Baseline to 3-month Follow-up: Psychological Safety
Time Frame: Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
Psychological safety (affective state) was assessed with Edmondson's (1999) Psychological Safety scale of 7 items rated on a 7-point Likert scale (1-7).
Scores were averaged; higher scores indicate more psychological safety.
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Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
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Change in Team Functioning From Baseline to 3-month Follow-up: Learning Behavior
Time Frame: Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
Learning behavior (behavioral process) was assessed with Edmondson's (1999) Learning Behavior scale of 7 items rated on a 7-point Likert scale (1-7).
Scores were averaged; higher scores indicate more learning behavior.
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Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
|
Change in Team Performance From Baseline to 3-month Follow-up
Time Frame: Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
The overall quality of work done by the team will be assessed with Edmondson's (1999) Team Performance scale of 5 items rated on a 7-point Likert scale.
Scores will be averaged; higher scores indicate better performance.
|
Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth A McGuier, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2022
Primary Completion (Actual)
March 22, 2023
Study Completion (Actual)
March 22, 2023
Study Registration Dates
First Submitted
April 26, 2022
First Submitted That Met QC Criteria
May 6, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY21110090
- UL1TR001857 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.
IPD Sharing Time Frame
Data will be available after manuscripts reporting the main findings are accepted for publication.
IPD Sharing Access Criteria
Contact the principal investigator to request access to the deidentified data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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