Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03137459
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2017-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STAMP: Sharing and Talking About My Preferences
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083362', 'term': 'Transtheoretical Model'}], 'ancestors': [{'id': 'D000083342', 'term': 'Health Belief Model'}, {'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008960', 'term': 'Models, Psychological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'terri.fried@yale.edu', 'phone': '203-932-5711', 'title': 'Dr. Terri Fried', 'phoneExt': '5412', 'organization': 'Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. 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For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.', 'otherNumAtRisk': 455, 'deathsNumAtRisk': 455, 'otherNumAffected': 0, 'seriousNumAtRisk': 455, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.\n\nUsual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.', 'otherNumAtRisk': 454, 'deathsNumAtRisk': 454, 'otherNumAffected': 0, 'seriousNumAtRisk': 454, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. 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Participants in this group will not receive any components of the TTM intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.059', 'ciLowerLimit': '.014', 'ciUpperLimit': '.105', 'estimateComment': 'Analysis performed using GEE to account for clustering of participants within practices.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.93', 'estimateComment': 'Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Complete a Living Will', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. 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For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.\n\nUsual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.070', 'ciLowerLimit': '-.05', 'ciUpperLimit': '.188', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '.72', 'ciUpperLimit': '1.85', 'estimateComment': 'Accounting for clustering and adjusting for covariates as described for primary outcome', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who had not communicated about quality versus quantity of life at baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.\n\nTranstheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. 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Participants in this group will not receive any components of the TTM intervention.'}], 'periods': [{'title': '2-month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '455'}, {'groupId': 'FG001', 'numSubjects': '454'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '387'}, {'groupId': 'FG001', 'numSubjects': '412'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unable to reach', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Refused assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Acutely ill', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '4-month Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '451'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '405'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unable to reach', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Refused assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Acutely ill', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': '6-months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '434'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '430'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refused assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Acutely ill', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '20 ambulatory internal medicine practices, matched in pairs according to practice type and percentage of patients age 65+, non-White, and receiving Medicaid', 'preAssignmentDetails': "Because randomization occurred at the level of the practice, participants' assignment to group was determined before any information was known about them. However, there were participants who were excluded from they study before beginning any study procedures. These included: 1 matched set of practices was excluded for failing to meet minimum enrollment with 12 participants; 6 participants consented in error; 25 participants refused the baseline interview."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '909', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.\n\nTranstheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.\n\nUsual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '880', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', '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': '76', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '339', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': '<=12th grade', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': '>12th grade', 'measurements': [{'value': '318', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '676', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Employed', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline stage of change: living will', 'classes': [{'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Contemplation', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}, {'title': 'Preparation', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Action/maintenance', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline stage of change: healthcare agent', 'classes': [{'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Contemplation', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}, {'title': 'Preparation', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Action/maintenance', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline stage of change: communication about quality versus quantity of life', 'classes': [{'categories': [{'title': 'Precontemplation', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Contemplation', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Preparation', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Action/maintenance', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '593', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-01', 'size': 169911, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-18T08:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 909}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2017-04-27', 'resultsFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-19', 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record.', 'timeFrame': '6 months', 'description': "The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Complete a Living Will', 'timeFrame': '6-months'}, {'measure': 'Number of Participants Who Assign a Healthcare Agent', 'timeFrame': '6 months'}, {'measure': 'Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transtheoretical Model (TTM)'], 'conditions': ['Advanced Care Planning (ACP)']}, 'referencesModule': {'references': [{'pmid': '34461035', 'type': 'DERIVED', 'citation': "Fried TR, Paiva AL, Redding CA, Iannone L, O'Leary JR, Zenoni M, Risi MM, Mejnartowicz S, Rossi JS. Effect of the STAMP (Sharing and Talking About My Preferences) Intervention on Completing Multiple Advance Care Planning Activities in Ambulatory Care : A Cluster Randomized Controlled Trial. Ann Intern Med. 2021 Nov;174(11):1519-1527. doi: 10.7326/M21-1007. Epub 2021 Aug 31."}, {'pmid': '30099405', 'type': 'DERIVED', 'citation': "Fried TR, Redding CA, Martino S, Paiva A, Iannone L, Zenoni M, Blakley LA, Rossi JS, O'Leary J. Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials. BMJ Open. 2018 Aug 10;8(8):e025340. doi: 10.1136/bmjopen-2018-025340."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of an individually transtheoretical model (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.', 'detailedDescription': 'This will be a randomized controlled trial examining the effect of an individually TTM-tailored intervention on the proportion of middle-age and older persons recruited from primary care practices who complete four ACP behaviors (completion of a living will, assignment of a health care proxy, and communication with loved ones and with their clinician about views on quality versus quantity of life) over six months, compared with usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings.\n\nExclusion Criteria:\n\n* Severe hearing impairment, defined as being unable to participate in a telephone conversation.\n* Severe visual impairment, defined as being unable to read large-print materials.\n* Moderate to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term recall of \\<2/3 objects at 2 minutes.\n* Primary language other than English.\n* Having completed all of the four ACP behaviors that are the focus of this study."}, 'identificationModule': {'nctId': 'NCT03137459', 'acronym': 'STAMP', 'briefTitle': 'STAMP: Sharing and Talking About My Preferences', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'STAMP: Sharing and Talking About My Preferences', 'orgStudyIdInfo': {'id': '1604017648'}, 'secondaryIdInfos': [{'id': '1R01NR016007-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR016007-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTM', 'description': 'Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.', 'interventionNames': ['Behavioral: Transtheoretical Model (TTM) of health behavior change']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Transtheoretical Model (TTM) of health behavior change', 'type': 'BEHAVIORAL', 'description': 'Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.', 'armGroupLabels': ['TTM']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Northeast Medical Groups', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Terri Fried, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Internal Medicine: Geriatrics: Claude D. Pepper Older Americans Independence Center; Dorothy Adler Geriatric Assessment Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}