Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02418403
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2015-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consumer Engagement to Increase Advance Care Planning: Patient Randomization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Having an advance care planning conversation with one's primary care provider", 'timeFrame': '3 months', 'description': "Primary care providers' documentation of an advance care planning conversation in the chart and/or via a Partnership HealthPlan of California ACP attestation form."}], 'secondaryOutcomes': [{'measure': 'Completion of "Prepare for Your Care" website modules', 'timeFrame': '3 months', 'description': 'Logging into the website, completing the modules, and creating an action plan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advance Care Planning']}, 'descriptionModule': {'briefSummary': 'This is a study of the effect of consumer-directed financial incentives on completion of advance care planning among Medi-Cal patients.', 'detailedDescription': 'Older adults receiving primary care from one of three clinics contracting with Partnership HealthPlan of California, a multi-county Medi-Cal managed care plan will be mass randomized to receiving educational materials regarding advance care planning with or without a financial reward for completing advance care planning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partnership HealthPlan of California enrollee\n* Receipt of primary care from one of 3 participating clinics (Ole, Petaluma, West County)\n* Age \\> 65\n\nExclusion Criteria:\n\n* \\> 75'}, 'identificationModule': {'nctId': 'NCT02418403', 'briefTitle': 'Consumer Engagement to Increase Advance Care Planning: Patient Randomization', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Consumer-directed Financial Incentives to Increase Advance Care Planning Among Medi-Cal Patients', 'orgStudyIdInfo': {'id': 'PRO14110340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PREPARE', 'description': 'Access to "Prepare for Your Care" website and written encouragement to discuss ACP with one\'s PCP.', 'interventionNames': ['Behavioral: Educational website']}, {'type': 'EXPERIMENTAL', 'label': 'PREPARE+financial incentive', 'description': 'Access to "Prepare for Your Care" website and written encouragement to discuss ACP with one\'s PCP; offer of $50 to complete the website and entry into $1000 lottery for discussing ACP with one\'s PCP.', 'interventionNames': ['Behavioral: Financial incentive', 'Behavioral: Educational website']}], 'interventions': [{'name': 'Financial incentive', 'type': 'BEHAVIORAL', 'description': 'Offer of money designed to overcome barriers to advance care planning.', 'armGroupLabels': ['PREPARE+financial incentive']}, {'name': 'Educational website', 'type': 'BEHAVIORAL', 'description': 'Research-verson of the "Prepare for your care" website (www.prepareforyourcare.org)', 'armGroupLabels': ['PREPARE', 'PREPARE+financial incentive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94534-1675', 'city': 'Fairfield', 'state': 'California', 'country': 'United States', 'facility': 'Partnership HealthPlan of California', 'geoPoint': {'lat': 38.24936, 'lon': -122.03997}}], 'overallOfficials': [{'name': 'Amber Barnato, MD MPH MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amber Barnato, MD, MPH, MS', 'investigatorAffiliation': 'University of Pittsburgh'}}}}