Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-24 @ 3:49 PM
Study NCT ID:
NCT01966068
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fiks@email.chop.edu', 'phone': '267-426-2304', 'title': 'Alexander Fiks, MD, MSCE', 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Enrollment occurred in practices across 11 states, yet more than half of practices were within a single health system thus affecting generalizability. This study also includes a relatively short follow-up period.'}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'eventGroups': [{'id': 'EG000', 'title': 'MyAsthma Web Portal', 'description': "The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.\n\nMyAsthma Web Portal", 'otherNumAtRisk': 237, 'otherNumAffected': 0, 'seriousNumAtRisk': 237, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MyAsthma Web Portal Sustained Use', 'description': 'Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once'}, {'id': 'OG001', 'title': 'MyAsthma Portal Adoption', 'description': 'Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 Months', 'description': 'Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MyAsthma Web Portal', 'description': "The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}]}, {'type': 'Used the MyAsthma Portal at Least Once', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}]}, {'type': 'Use the MyAsthma Portal More Than Once', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}]}]}], 'recruitmentDetails': "Subjects were recruited from 2 practice-based research networks. To ensure low-income children were represented, practices were required to have at least 20% insured by Medicaid or the Children's Health Insurance Program. 9,133 families were invited to enroll.", 'preAssignmentDetails': '294 parents/guardians of 294 children consented to participate in the study. Of these, 237 logged onto the MyAsthma portal at least once.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MyAsthma Web Portal Sustained Use', 'description': 'Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once'}, {'id': 'BG001', 'title': 'MyAsthma Web Portal Adoption', 'description': 'Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Parent's Age", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '6-9 Years', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': '10-12 Years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Child's Age", 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Child's Gender", 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Parent's Race", 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Unkown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Child's Race", 'unitOfMeasure': 'participants'}, {'title': 'Parent Education', 'classes': [{'title': 'High School or Less', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Some College/Associates', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': "Bachelor's or Higher", 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parent Employment Status', 'classes': [{'title': 'Working Outside the Home', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': 'Self-Employed', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Working Without Pay', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Parent's Relation to Child", 'classes': [{'title': 'Mother', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Child's Asthma Severity", 'classes': [{'title': 'Intermittent', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Mild Persistent', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Moderate/Severe Persistent', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medical Practice Setting', 'classes': [{'title': 'Urban', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Rural', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Suburban', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population included every family of children with asthma who logged onto the MyAsthma portal at least once.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2013-10-11', 'resultsFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-19', 'studyFirstPostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use', 'timeFrame': 'Up to 6 Months', 'description': 'Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Pediatrics', 'Health Technology', 'Meaningful Use Stage-3', 'Web Portal'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '27357835', 'type': 'DERIVED', 'citation': 'Fiks AG, DuRivage N, Mayne SL, Finch S, Ross ME, Giacomini K, Suh A, McCarn B, Brandt E, Karavite D, Staton EW, Shone LP, McGoldrick V, Noonan K, Miller D, Lehmann CU, Pace WD, Grundmeier RW. Adoption of a Portal for the Primary Care Management of Pediatric Asthma: A Mixed-Methods Implementation Study. J Med Internet Res. 2016 Jun 29;18(6):e172. doi: 10.2196/jmir.5610.'}]}, 'descriptionModule': {'briefSummary': "This study will enroll parents/guardians of children who receive treatment at one of the pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS) network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC) network.\n\nThe study will use an evidence-based conceptual model to study determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an already functional, electronic health record (EHR)-linked asthma portal, MyAsthma. The study will measure the portal's feasibility and determine the impact on providing asthma education and fostering patient engagement as well as the ability to collect patient-reported outcomes for children, evaluate medication use and side effects and track parents' preferences and goals.", 'detailedDescription': "This study uses a newly published, evidence-based conceptual model to study the determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an asthma portal, MyAsthma, in the national, Agency for Health Care Research and Quality(AHRQ)-funded, Center for Pediatric Practice Research and Learning. Technically, the portal will be implemented with 2 innovative approaches that facilitate rapid cycle evaluation in multiple Electronic Health Records (EHRs). Although many patient portals are simple vehicles for transferring information about upcoming appointments, test results or laboratory findings, the asthma portal in this project extends this basic functionality to provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' preferences and goals. Because asthma is an AHRQ priority condition which addresses three AHRQ priority criteria (children, low income, and special health care needs), our study will use this population to focus on stage 3 Meaningful Use (MU3) objectives. It is the hope that by conducting this study, translational knowledge will be gained to make recommendations for practice implementation and actionable policy statements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria For Parents/Guardians:\n\n1. Parent/guardian of a child who:\n\n * Is between the ages of 6-12 years old\n * Has a diagnosis of asthma on his/her problem list at the time of recruitment\n * Has had an office visit with asthma as a diagnosis within the past 12 months\n2. Must be able to speak and read English\n\nExclusion Criteria For Parents/Guardians:\n\n1. Child has not had an office visit for asthma with in the last 12 months\n2. Parent or guardian does not speak or read English'}, 'identificationModule': {'nctId': 'NCT01966068', 'briefTitle': 'Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3', 'orgStudyIdInfo': {'id': '13-010285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyAsthma Web Portal', 'description': "The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month (for a total of 3 portal visits in 6 months), and the information entered by parents will be shared through the electronic health record with the child's primary care provider.", 'interventionNames': ['Other: MyAsthma Web Portal']}], 'interventions': [{'name': 'MyAsthma Web Portal', 'type': 'OTHER', 'description': 'Parents will log on to the MyAsthma Web Portal up to three different times over a 6 month period. During each portal visit, parents will be asked to complete a survey which will include questions regarding their views on treatment preferences, goals, asthma control, and medications for their child with asthma.', 'armGroupLabels': ['MyAsthma Web Portal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pediatrick Research in Office Settings (PROS)', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Pediatric Research Consortium of the Children's Hospital of Philadelphia (PeRC)", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alexander Fiks, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'American Academy of Pediatrics', 'class': 'OTHER'}, {'name': 'DARTNet Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}