Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'millerea3@upmc.edu', 'phone': '412-246-5895', 'title': 'Dr. Elizabeth McGuier', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 9 months', 'description': 'All-Cause Mortality among participants was not assessed; therefore the number of participants at risk for All-Cause Mortality is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Teamwork Knowledge From Baseline to 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.60', 'spread': '10.87', 'groupId': 'OG000'}, {'value': '74.72', 'spread': '10.82', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.00', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '75.00', 'spread': '7.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.25', 'ciLowerLimit': '0.76', 'ciUpperLimit': '7.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.85', 'groupDescription': 'Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Satterthwaite Approximation'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': '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.', 'unitOfMeasure': 'percentage correct answers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive data: Team members with data for that timepoint. Intent-to-treat analysis: All team members with data at 1 or more timepoints'}, {'type': 'PRIMARY', 'title': 'Change in Teamwork Skill Use From Baseline to 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.22', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.19', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Satterthwaite Approximation'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive data: Team members with data for that timepoint. Intent-to-treat analysis: All team members with data at 1 or more timepoints'}, {'type': 'PRIMARY', 'title': 'Acceptability of Self-guided Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline (Beginning of self-guided implementation process)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (midpoint of self-guided implementation process)', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Month 7 (End of study)', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only rated by key informants in CACs randomized to TeamTRACS'}, {'type': 'PRIMARY', 'title': 'Appropriateness of Self-guided Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline (Beginning of self-guided implementation process)', 'categories': [{'measurements': [{'value': '3.63', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (midpoint of self-guided implementation process)', 'categories': [{'measurements': [{'value': '4.25', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Month 7 (End of study)', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only rated by key informants in CACs randomized to TeamTRACS'}, {'type': 'PRIMARY', 'title': 'Feasibility of Self-guided Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline (Beginning of self-guided implementation process)', 'categories': [{'measurements': [{'value': '4.50', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (midpoint of self-guided implementation process)', 'categories': [{'measurements': [{'value': '4.00', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Month 7 (End of study)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only rated by key informants in CACs randomized to TeamTRACS'}, {'type': 'SECONDARY', 'title': 'Change in Team Functioning From Baseline to 3-month Follow-up: Psychological Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.46', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.51', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '5.94', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive data: Team members with data for that timepoint. Intent-to-treat analysis: All team members with data at 1 or more timepoints'}, {'type': 'SECONDARY', 'title': 'Change in Team Functioning From Baseline to 3-month Follow-up: Learning Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.77', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '4.96', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive data: Team members with data for that timepoint. Intent-to-treat analysis: All team members with data at 1 or more timepoints'}, {'type': 'SECONDARY', 'title': 'Change in Team Performance From Baseline to 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'OG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.47', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.63', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '6.07', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '1.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive data: Team members with data for that timepoint. Intent-to-treat analysis: All team members with data at 1 or more timepoints'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'FG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'periods': [{'title': 'Participants Entering at Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '100'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '50'}]}, {'type': 'Completed Baseline', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '87'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '48'}]}, {'type': 'Started Followup', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '83'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '72'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '28'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Not eligible for followup - no longer member of team', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Participants Entering at Follow-Up', 'milestones': [{'type': 'STARTED', 'comment': "Participants who were not part of the team at baseline. All new participants were affiliated with participating Children's Advocacy Centers; no centers entered at follow-up.", 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': "Children's Advocacy Centers", 'recruitmentDetails': 'Only current team members were eligible to participate at each timepoint. Participants who completed baseline data collection but left the team before follow-up were not invited to participate in follow-up data collection. Participants who joined the team after baseline were invited to participate in follow-up data collection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.\n\nTeamTRACS: 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.'}, {'id': 'BG001', 'title': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Age category is unknown for 13 participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.46', 'spread': '11.41', 'groupId': 'BG000'}, {'value': '45.33', 'spread': '11.46', 'groupId': 'BG001'}, {'value': '41.40', 'spread': '11.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age is unknown for 15 participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported Gender', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender is unknown for 13 participants.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics are reported for all unique participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-14', 'size': 123074, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-14T11:00', 'hasProtocol': True}, {'date': '2023-01-18', 'size': 210198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-12T14:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-04-26', 'resultsFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-22', 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Teamwork Knowledge From Baseline to 3-month Follow-up', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': '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.'}, {'measure': 'Change in Teamwork Skill Use From Baseline to 3-month Follow-up', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': '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.'}, {'measure': 'Acceptability of Self-guided Implementation', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.'}, {'measure': 'Appropriateness of Self-guided Implementation', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.'}, {'measure': 'Feasibility of Self-guided Implementation', 'timeFrame': 'Beginning, midpoint, and end of self-guided implementation process (Months 0, 5, & 7)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Team Functioning From Baseline to 3-month Follow-up: Psychological Safety', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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."}, {'measure': 'Change in Team Functioning From Baseline to 3-month Follow-up: Learning Behavior', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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."}, {'measure': 'Change in Team Performance From Baseline to 3-month Follow-up', 'timeFrame': 'Baseline, 3-month follow-up (Month 7, 3 months after training workshop)', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multidisciplinary teamwork', 'implementation'], 'conditions': ['Teamwork', 'Implementation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.\n\nExclusion Criteria:\n\n* Under 18 years old'}, 'identificationModule': {'nctId': 'NCT05370157', 'briefTitle': 'TeamTRACS Pilot (CTSI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Improving Teamwork in Rural Child Advocacy Centers: A Hybrid-Effectiveness Implementation Trial of TeamTRACS', 'orgStudyIdInfo': {'id': 'STUDY21110090'}, 'secondaryIdInfos': [{'id': 'UL1TR001857', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001857', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)', 'description': '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.', 'interventionNames': ['Behavioral: TeamTRACS']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Comparison', 'description': 'CACs randomized to the waitlist comparison (n = 2) will participate in TeamTRACS approximately 4 months after CACs in the intervention condition.'}], 'interventions': [{'name': 'TeamTRACS', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['TeamTRACS (Team Training in Roles, Awareness, Communication, and Support)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Elizabeth A McGuier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available after manuscripts reporting the main findings are accepted for publication.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Contact the principal investigator to request access to the deidentified data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Elizabeth McGuier', 'investigatorAffiliation': 'University of Pittsburgh'}}}}