Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 6:20 PM
Study NCT ID:
NCT02289105
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Active Choice on Advance Directive Completion Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shalpern@exchange.upenn.edu', 'phone': '215-5739461', 'title': 'Dr. Scott Halpern', 'organization': 'Fostering Improvement in End-of-Life Decision Science Program'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study population is not ideal - healthy workers may not benefit from AD completion as much as older or seriously ill patients.'}}, 'adverseEventsModule': {'description': 'We did not collect or assess serious adverse events because the study is minimal risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.", 'otherNumAtRisk': 642, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.', 'otherNumAtRisk': 637, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants That Select to Complete an Advance Directive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.39'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline - up to 1 year', 'description': 'We will analyze the effects of the active choice intervention on rates of completion.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Already Have ADs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.'}], 'classes': [{'categories': [{'measurements': [{'value': '.065', 'groupId': 'OG000'}, {'value': '.063', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline - up to 1 year', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Return a Signed AD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.'}], 'classes': [{'categories': [{'measurements': [{'value': '.078', 'groupId': 'OG000', 'lowerLimit': '.058', 'upperLimit': '.101'}, {'value': '.039', 'groupId': 'OG001', 'lowerLimit': '.026', 'upperLimit': '.057'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline - up to 1 year', 'description': 'This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Selections on ADs and Declination Forms', 'timeFrame': 'Baseline - up to 1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '642'}, {'groupId': 'FG001', 'numSubjects': '637'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '642'}, {'groupId': 'FG001', 'numSubjects': '637'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '1279', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mandatory Active Choice', 'description': "The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.\n\nMandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '39'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '37'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '472', 'groupId': 'BG001'}, {'value': '918', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to answer or missing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Mixed or Other', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to answer or missing', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '642', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '1279', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Employment Status', 'classes': [{'title': 'Full-time', 'categories': [{'measurements': [{'value': '464', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '933', 'groupId': 'BG002'}]}]}, {'title': 'Part-time', 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest level of education', 'classes': [{'title': 'Graduate Degree', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': 'College Degree', 'categories': [{'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}, {'title': 'Some College', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}, {'title': 'High School or Less', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Degree', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '1010', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2014-11-05', 'resultsFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-01', 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Selections on ADs and Declination Forms', 'timeFrame': 'Baseline - up to 1 year'}], 'primaryOutcomes': [{'measure': 'Proportion of Participants That Select to Complete an Advance Directive', 'timeFrame': 'Baseline - up to 1 year', 'description': 'We will analyze the effects of the active choice intervention on rates of completion.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Who Already Have ADs', 'timeFrame': 'Baseline - up to 1 year'}, {'measure': 'Proportion of Participants Who Return a Signed AD', 'timeFrame': 'Baseline - up to 1 year', 'description': 'This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advance Directive', 'Active Choice', 'Decision making'], 'conditions': ['Advance Directive Completion']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates.', 'detailedDescription': "Nearly 70% of Americans express the desire to die at home, and most individuals want to avoid aggressive or futile care. Despite this, more than half of Americans die in a hospital. Advance directives provide the opportunity to provide, in advance, one's wishes for end of life care, however their completion rates are low. The overall objective of this project is to assess if an active choice intervention can increase AD completion rates. Eligible participants for this study will be all new employees of the University of Pennsylvania Health System (UPHS) who need to complete their online employment paperwork via the On Boarding portal. Participants will have an advanced health care planning task programmed as part of their On Boarding online employment paperwork. Upon selection of the task, each participant will be directed a designated Advance Healthcare Planning (AHCP) website. Participants will be randomized into either the active choice or control arm of the study and proceed through steps to complete or not complete an AD according to the decision making process of the given study arm. All participants in both groups will have access to additional online and telephone resources thought the entire study for any questions. Participants in the active choice group will be given directions stating they are required to complete either the advanced directive or the declination form in order to complete their On Boarding process. Participants in the control group will be given directions stating that completion of the AD is optional."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New participants of the University of Pennsylvania Health System who have not yet completed their On Boarding process.\n* 18 years of age or older\n* Have proficiency in reading, writing, and speaking English\n\nExclusion Criteria:\n\n* All new UPHS employees will be enrolled'}, 'identificationModule': {'nctId': 'NCT02289105', 'briefTitle': 'Impact of Active Choice on Advance Directive Completion Rates', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The Impact of Active Choice on Completion Rates of Advanced Directives in New Employees of an Academic University Hospital', 'orgStudyIdInfo': {'id': '818456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mandatory active choice', 'description': 'The mandatory active choice group will be presented two forms at the same time. The first form will be a legally valid AD. The second form will be a declination form. Participants in the intervention arm will be required to complete, and submit either of the two forms the task.', 'interventionNames': ['Behavioral: Mandatory active choice']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control group will be presented an AD form only and will be encouraged to complete, and submit the form without having to declare the choice of completing or declining the AD.'}], 'interventions': [{'name': 'Mandatory active choice', 'type': 'BEHAVIORAL', 'description': 'the mandatory active choice group, will be presented two forms at the same time. The first form will be a legally valid AD. The second form will be a declination form. Participants in the intervention arm will be required to complete, and submit either of the two forms the task.', 'armGroupLabels': ['Mandatory active choice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Scott D Halpern, MD, PhD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}