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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: TeamTRACS
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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.
Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)
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.
Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline, 3-month follow-up (Month 7, 3 months after training workshop)
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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