Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT02319967
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chicagotrial@uic.edu', 'phone': '312-413-3291', 'title': 'Jerry A. Krishnan, MD, PhD', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': "Participants were recruited in the emergency department during an asthma exacerbation. As reviewed and approved by the study's independent data and safety monitoring board, subsequent visits to the emergency department and hospitalizations were expected in this population and were, therefore, not reported as serious adverse events or other adverse events.", 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CAPE', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CAPE + Home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PROMIS Asthma Impact Scale (v1.0, SF8a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'groupId': 'OG000', 'lowerLimit': '-17.3', 'upperLimit': '0.0'}, {'value': '-9.3', 'groupId': 'OG001', 'lowerLimit': '-16.4', 'upperLimit': '-5.0'}, {'value': '-11.9', 'groupId': 'OG002', 'lowerLimit': '-19.3', 'upperLimit': '-6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma.\n\nPROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is \\[-44.7 to 44.7\\]\n\nPROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is \\[-48 to 48\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'PRIMARY', 'title': 'PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '9.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers.\n\nPROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is \\[-35.1 to 35.1\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'Childhood Asthma Control Test (cACT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '5.8'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '7.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma.\n\nChildhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is \\[-27 to 27\\]\n\nThe reported value represents a change in score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.', 'unitOfMeasure': 'score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'PROMIS Anxiety (v1.0, SF4a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-10.9', 'upperLimit': '0.0'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-11.2', 'upperLimit': '0.0'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-13.4', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety.\n\nPROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is \\[-41.3 to 41.3\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'PROMIS Depression (v1.0, SF4a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-7.3', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression.\n\nPROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is \\[-38.4 to 38.4\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'PROMIS Fatigue (v1.0, SF4a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-9.4', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.5', 'upperLimit': '4.4'}, {'value': '-2.6', 'groupId': 'OG002', 'lowerLimit': '-12.2', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue.\n\nPROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is \\[-42.1 to 42.1\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'PROMIS Sleep Disturbance (v1.0, SF4a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '2.4'}, {'value': '-1.9', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance.\n\nPROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is \\[-41.3 to 41.3\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': "Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': "The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life.\n\nPediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is \\[-6 to 6\\]\n\nThe reported value represents a change in overall score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change.", 'unitOfMeasure': 'score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post index ED discharge', 'description': 'Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post index ED discharge', 'description': 'Count of participants (children) with at least one all-cause hospitalization at 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post index ED discharge', 'description': 'Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post index ED discharge', 'description': 'Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post index ED discharge', 'description': 'Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use systemic corticosteroids', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use an inhaled rescue medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'OG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'OG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'FG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'FG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '45'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Usual Care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'id': 'BG001', 'title': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.'}, {'id': 'BG002', 'title': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nCommunity-health worker-led home visits.\n\nCAPE: Structured patient-centered ED discharge template completed prior to ED discharge.\n\nHome: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '1.9', 'groupId': 'BG002'}, {'value': '7.4', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorial', 'categories': [{'title': '5-7 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}, {'title': '8-11 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-01', 'size': 3646024, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-11T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-17', 'studyFirstSubmitDate': '2014-12-15', 'resultsFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Asthma Impact Scale (v1.0, SF8a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma.\n\nPROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is \\[-44.7 to 44.7\\]\n\nPROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is \\[-48 to 48\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.'}, {'measure': 'PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers.\n\nPROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is \\[-35.1 to 35.1\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.'}], 'secondaryOutcomes': [{'measure': 'Childhood Asthma Control Test (cACT)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma.\n\nChildhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is \\[-27 to 27\\]\n\nThe reported value represents a change in score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.'}, {'measure': 'PROMIS Anxiety (v1.0, SF4a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety.\n\nPROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is \\[-41.3 to 41.3\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change.'}, {'measure': 'PROMIS Depression (v1.0, SF4a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression.\n\nPROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is \\[-38.4 to 38.4\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change.'}, {'measure': 'PROMIS Fatigue (v1.0, SF4a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue.\n\nPROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is \\[-42.1 to 42.1\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change.'}, {'measure': 'PROMIS Sleep Disturbance (v1.0, SF4a)', 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': 'Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance.\n\nPROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is \\[-41.3 to 41.3\\]\n\nThe reported value represents a change in T-score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change.'}, {'measure': "Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)", 'timeFrame': 'Baseline and 6 months after index ED discharge', 'description': "The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life.\n\nPediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is \\[-6 to 6\\]\n\nThe reported value represents a change in overall score from baseline to 6 months after index ED discharge.\n\nA negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change."}, {'measure': 'Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits', 'timeFrame': '6 months post index ED discharge', 'description': 'Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months'}, {'measure': 'Number of Participants With All-cause Hospitalizations', 'timeFrame': '6 months post index ED discharge', 'description': 'Count of participants (children) with at least one all-cause hospitalization at 6 months'}, {'measure': 'Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids', 'timeFrame': '7 days post index ED discharge', 'description': 'Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge'}, {'measure': 'Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller', 'timeFrame': '7 days post index ED discharge', 'description': 'Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge'}, {'measure': 'Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider', 'timeFrame': '4 weeks post index ED discharge', 'description': 'Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge'}, {'measure': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use systemic corticosteroids'}, {'measure': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller'}, {'measure': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions to use an inhaled rescue medication'}, {'measure': 'Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff', 'timeFrame': 'At index ED discharge', 'description': 'Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['community health worker', 'emergency', 'asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '28366780', 'type': 'DERIVED', 'citation': 'Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, Thompson TM; CHICAGO Plan consortium. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemp Clin Trials. 2017 Jun;57:10-22. doi: 10.1016/j.cct.2017.03.015. Epub 2017 Mar 31.'}], 'seeAlsoLinks': [{'url': 'http://www.pcori.org/research-results/2013/coordinated-healthcare-interventions-childhood-asthma-gaps-outcomes-chicago', 'label': 'Patient-Centered Outcomes Research Institute (PCORI): Funding award details'}]}, 'descriptionModule': {'briefSummary': 'Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria (all of the following):\n\n1. Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);\n2. Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \\& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \\& Health Sciences System);\n3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);\n4. Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);\n5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;\n6. Diagnosis of asthma exacerbation by treating clinician;\n7. Treating ED clinician indicates the child is likely to be discharged to home; and\n8. Caregiver reports that English or Spanish is the preferred language at home.\n\nExclusion criteria (none of the following):\n\n1. Caregiver declines to provide informed consent, or the child declines to provide assent;\n2. Child is admitted to an intensive care unit or transferred to another healthcare facility;\n3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;\n4. Child is enrolled in another study involving a health-related intervention;\n5. A CHW is already visiting the home as part of another program;\n6. Child does not reside in Chicago."}, 'identificationModule': {'nctId': 'NCT02319967', 'acronym': 'CHICAGO', 'briefTitle': 'Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)', 'orgStudyIdInfo': {'id': '2014-1214'}, 'secondaryIdInfos': [{'id': 'AS-1307-05420', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Enhanced usual care', 'description': 'Inhaler technique education and distribution of spacers to all participants.'}, {'type': 'EXPERIMENTAL', 'label': 'ED-only', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.', 'interventionNames': ['Behavioral: CAPE']}, {'type': 'EXPERIMENTAL', 'label': 'ED-plus-home', 'description': 'Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.\n\nHome visits by a community health worker (CHW).', 'interventionNames': ['Behavioral: CAPE', 'Behavioral: CHW home visits']}], 'interventions': [{'name': 'CAPE', 'type': 'BEHAVIORAL', 'description': 'Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers', 'armGroupLabels': ['ED-only', 'ED-plus-home']}, {'name': 'CHW home visits', 'type': 'BEHAVIORAL', 'description': 'Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.', 'armGroupLabels': ['ED-plus-home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sinai Health System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Health & Hospitals System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jerry A Krishnan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sinai Health System', 'class': 'OTHER'}, {'name': 'Cook County Health & Hospitals System', 'class': 'OTHER'}, {'name': 'Rush University Medical Center', 'class': 'OTHER'}, {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'Chicago Department of Public Health', 'class': 'OTHER_GOV'}, {'name': 'Respiratory Health Association', 'class': 'UNKNOWN'}, {'name': 'Chicago Asthma Consortium', 'class': 'UNKNOWN'}, {'name': 'Illinois Institute of Technology', 'class': 'OTHER'}, {'name': 'Illinois Emergency Department Asthma Surveillance Project', 'class': 'UNKNOWN'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health', 'investigatorFullName': 'Jerry Krishnan', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}