Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04455893
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2020-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Don't Throw Your Heart Away: Clinician Study 3
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gchapman@andrew.cmu.edu', 'phone': '412-268-3665', 'title': 'Gretchen Chapman', 'organization': 'Carnegie Mellon University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Did not recruit as many participants as desired by power analysis.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'No adverse events in this benign behavioral intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Condition 1: Combined Only', 'description': 'Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Combined 2: Stratified Only', 'description': 'Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.\n\nStratified Transplant Survival: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \\[number of patients surviving after transplant with excellent organ\\]/\\[number of patients for whom excellent organ was accepted for transplant\\] marginal transplant survival = \\[number of patients surviving after transplant with marginal organ\\]/\\[number of patients for whom marginal organ was accepted for transplant\\]', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Choice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Condition 1: Combined Only', 'description': 'Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.'}, {'id': 'OG001', 'title': 'Combined 2: Stratified Only', 'description': 'Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.\n\nStratified Transplant Survival: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \\[number of patients surviving after transplant with excellent organ\\]/\\[number of patients for whom excellent organ was accepted for transplant\\] marginal transplant survival = \\[number of patients surviving after transplant with marginal organ\\]/\\[number of patients for whom marginal organ was accepted for transplant\\]'}], 'classes': [{'categories': [{'title': 'Number choosing non-selective center', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Number choosing selective center', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'The outcome variable will be a measure of binary choice between two hospitals: one with a selective donor-heart acceptance strategy and one with a non-selective donor heart acceptance strategy.\n\nParticipants will respond to the question "Which Hospital is a better choice for patients? Please click on one of the two tables below to indicate which hospital is the better choice." Participants will choose been two outcome tables featuring the selective and non-selective hospital (counterbalanced, such that each of the two choices is equally likely to be presented at top of the choice scenario in each condition). The number of participants that choose each hospital will be the measured outcome variable used in analyses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Condition 1: Combined Only', 'description': 'Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.'}, {'id': 'FG001', 'title': 'Combined 2: Stratified Only', 'description': 'Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.\n\nStratified Transplant Survival: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \\[number of patients surviving after transplant with excellent organ\\]/\\[number of patients for whom excellent organ was accepted for transplant\\] marginal transplant survival = \\[number of patients surviving after transplant with marginal organ\\]/\\[number of patients for whom marginal organ was accepted for transplant\\]'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Condition 1: Combined Only', 'description': 'Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.'}, {'id': 'BG001', 'title': 'Combined 2: Stratified Only', 'description': 'Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.\n\nStratified Transplant Survival: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \\[number of patients surviving after transplant with excellent organ\\]/\\[number of patients for whom excellent organ was accepted for transplant\\] marginal transplant survival = \\[number of patients surviving after transplant with marginal organ\\]/\\[number of patients for whom marginal organ was accepted for transplant\\]'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '68'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '69'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Measure in row does not differ'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-10', 'size': 127886, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-21T14:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2020-06-28', 'resultsFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-25', 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Choice', 'timeFrame': '1 day', 'description': 'The outcome variable will be a measure of binary choice between two hospitals: one with a selective donor-heart acceptance strategy and one with a non-selective donor heart acceptance strategy.\n\nParticipants will respond to the question "Which Hospital is a better choice for patients? Please click on one of the two tables below to indicate which hospital is the better choice." Participants will choose been two outcome tables featuring the selective and non-selective hospital (counterbalanced, such that each of the two choices is equally likely to be presented at top of the choice scenario in each condition). The number of participants that choose each hospital will be the measured outcome variable used in analyses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Transplant', 'Transplant Survival', 'Applied Ethics', 'Medical Student', 'Human Behavior', 'Decision Psychology'], 'conditions': ['Cardiac Transplant Disorder']}, 'descriptionModule': {'briefSummary': 'Publicly available outcome assessments for transplant programs do not make salient that some programs tend to reject many of the hearts they are offered, whereas other programs accept a broader range of donor offers. The investigators use empirical studies to test whether transplant center performance data (i.e. transplant and waitlist outcome statistics) that reflect center donor acceptance rates influence laypersons to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 125 heart transplant clinical personnel will be recruited from International Heart and Lung Society (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two different information presentation conditions. Participants will be asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose the hospital that they would consider to be "higher-performing" between two hospitals: one hospital with a non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a more selective, "cherrypicking" strategy (tends to reject donor offers that are less than "excellent" quality).', 'detailedDescription': 'Publicly available outcome assessments for transplant programs do not make salient that some programs tend to reject many of the hearts they are offered, whereas other programs accept a broader range of donor offers. The investigators use empirical studies to test whether transplant center performance data (i.e. transplant and waitlist outcome statistics) that reflect center donor acceptance rates influence laypersons to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 125 heart transplant clinical personnel will be recruited from International Heart and Lung Society (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two different information presentation conditions. Participants will be asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose the hospital that they would consider to be "higher-performing" between two hospitals: one hospital with a non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a more selective, "cherrypicking" strategy (tends to reject donor offers that are less than "excellent" quality).\n\nCondition 1 ("baseline" condition): view only combined transplant survival (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center)\n\nCondition 2: view only stratified transplant survival (e.g. transplant survival rate stratified into patients who received excellent donor organs and patients who received less than optimal donor organs)\n\nParticipants will then be asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose the hospital that they would consider to be "higher-performing" between two hospitals: one hospital with a non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a more selective, "cherry-picking" strategy (tends to reject donor offers that are less than "excellent" quality). In order to identify the decision process that underlies this choice pattern, the investigators will examine a putative mediator. Specifically, participants will be asked to rate the extent to which they considered patients\' chances of getting an excellent heart, avoiding a less-than-optimal heart, and getting any type of heart when making their choice between the two hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants will be asked to participate if they confirm the following inclusion criteria in the consent form.\n\n1. 18 years of age or older\n2. must read and understand the information in the consent form\n3. must want to participate in the research and continue with the survey\n4. must be clinical transplant personnel\n\nExclusion Criteria:\n\n1\\. participants who do not meet primary criterion of being clinical transplant personnel.'}, 'identificationModule': {'nctId': 'NCT04455893', 'briefTitle': "Don't Throw Your Heart Away: Clinician Study 3", 'organization': {'class': 'OTHER', 'fullName': 'Carnegie Mellon University'}, 'officialTitle': "Don't Throw Your Heart Away: Clinician Study 3", 'orgStudyIdInfo': {'id': '1 F30 HL152526-01-C'}, 'secondaryIdInfos': [{'id': '1F30HL152526-01', 'link': 'https://reporter.nih.gov/quickSearch/1F30HL152526-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Condition 1: Combined only', 'description': 'Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.'}, {'type': 'EXPERIMENTAL', 'label': 'Combined 2: Stratified only', 'description': 'Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.', 'interventionNames': ['Other: Stratified Transplant Survival']}], 'interventions': [{'name': 'Stratified Transplant Survival', 'type': 'OTHER', 'description': 'The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = \\[number of patients surviving after transplant with excellent organ\\]/\\[number of patients for whom excellent organ was accepted for transplant\\] marginal transplant survival = \\[number of patients surviving after transplant with marginal organ\\]/\\[number of patients for whom marginal organ was accepted for transplant\\]', 'armGroupLabels': ['Combined 2: Stratified only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Carnegie Mellon University', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Alison E Butler, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carnegie Mellon University'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/xe92f/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'All of the raw files, statistical analysis protocol descriptions, and information for proper analysis will be available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts.', 'ipdSharing': 'YES', 'description': "The PI will make all of the raw IPD files - together with statistical analysis protocol descriptions and information for proper analysis available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts. All human subjects data are anonymized immediately when they are initially written from the online survey platform to the server, and thus participant confidentiality will not be compromised by this plan for data sharing.\n\nAll hypotheses, methods, and planned analyses for the applicant's studies will be pre-registered on ClinicalTrials.gov and Open Science Framework."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carnegie Mellon University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gretchen Chapman', 'investigatorAffiliation': 'Carnegie Mellon University'}}}}