Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 8:11 AM
Study NCT ID:
NCT03794700
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2018-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Evaluation of Hospice Decision Support Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'channing.tate@cuanschutz.edu', 'phone': '3037248985', 'title': 'Channing Tate, PHD Assistant Professor', 'organization': 'University of Colorado Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Did not receive intervention (i.e. Patient Decision aid)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospice Knowledge Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Did not receive intervention (i.e. Patient Decision Aid)'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month follow-up', 'description': 'Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hospice Beliefs and Attitudes Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Did not receive intervention (i.e. Patient Decision Aid)'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '40'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-Month follow up', 'description': "8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Decision Self Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Did not receive intervention (i.e. Patient Decision Aid)'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month Follow up', 'description': "Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Hospice Decision Aid', 'description': 'Did not receive the intervention (i.e. Hospice Decision Aid)'}, {'id': 'FG001', 'title': 'Hospice Decision Aid', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Participants did not review the intervention (i.e. Hospice Decision Aid)'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.\n\nHospice Decision Aids: Paper and video hospice decision aid'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hospice Knowledge Test', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '23'}, {'value': '18', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '18', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'description': "Hospice knowledge was quantitatively assessed using the 23-item hospice knowledge survey.This survey consists of true/false questions, with scores ranging from 0 to 23, awarding one point for each correct answer. A higher score indicates more knowledge of hospice. The Cronbach's α = 0.75 indicates a good degree of internal reliability. Absolute values measured at baseline and one month", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hospice Beliefs and Attitudes Scale', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '40'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'description': 'The HBAS is an 8-item scale designed to measure beliefs and attitudes regarding hospice care. T Cronbach\'s α = .74 for the scale, indicating a good degree of internal reliability.The HBAS is scored from 8 to 40, with a higher score indicating more positive views of hospice care. The scale uses a 5-item Likert scale with answers ranging from "strongly disagree" to "strongly agree" for all questions. Absolute values measured at baseline and one month', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Decision Self Efficacy Scale', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '100'}, {'value': '87', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '89', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-08', 'size': 252500, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-13T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2018-12-21', 'resultsFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-08', 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospice Knowledge Scale', 'timeFrame': '1 month follow-up', 'description': 'Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.'}, {'measure': 'Hospice Beliefs and Attitudes Scale', 'timeFrame': '1-Month follow up', 'description': "8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. ."}, {'measure': 'Decision Self Efficacy Scale', 'timeFrame': '1 month Follow up', 'description': "Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hospice', 'End-of-life', 'Patient decision aid', 'Shared decision making'], 'conditions': ['Hospice', 'End-of-life Decision Making', 'Hospice Decision Making']}, 'referencesModule': {'references': [{'pmid': '35944273', 'type': 'DERIVED', 'citation': 'Brereton E, Harger G, Matlock DD, Dorsey Holliman B, Tate CE. How Do Patients Describe Hospice Care? A Qualitative Analysis of the Language Used by Older Adults to Describe Hospice Care. J Palliat Med. 2022 Nov;25(11):1692-1696. doi: 10.1089/jpm.2022.0011. Epub 2022 Aug 9.'}, {'pmid': '33439075', 'type': 'DERIVED', 'citation': 'Tate CE, Venechuk G, Pierce K, Khazanie P, Ingle MP, Morris MA, Allen LA, Matlock DD. Development of a Decision Aid for Patients and Families Considering Hospice. J Palliat Med. 2021 Apr;24(4):505-513. doi: 10.1089/jpm.2020.0250. Epub 2021 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to determine the feasibility and acceptability of a hospice decision aid among a diverse population of older adults at multiple stages of illness (Aim 1) and to determine the preliminary efficacy of the hospice decision aid on decision quality, hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability, and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse population of older adults, additionally the study will simultaneously explore barriers to PtDA implementation in both an outpatient primary care and inpatient palliative care setting. The study will also gather sufficient pilot data to support a subsequent effectiveness/implementation trial and thus address the absence of quality of SDM interventions for end-of-life care decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 or older.\n* At least one life-limiting illness or syndrome.\n\nExclusion Criteria:\n\n* Non-English speakers.\n* Patients with cognitive Impairments preventing ability to provide informed consent.\n* Patients on isolation precautions due to resistant bacteria or impaired immune function.'}, 'identificationModule': {'nctId': 'NCT03794700', 'briefTitle': 'Pilot Evaluation of Hospice Decision Support Tools', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Pilot Evaluation of Hospice Decision Support Tools', 'orgStudyIdInfo': {'id': '18-1138'}, 'secondaryIdInfos': [{'id': '1R21AG059114-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG059114-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'OTHER', 'label': 'Intervention', 'description': 'Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.', 'interventionNames': ['Other: Hospice Decision Aids']}], 'interventions': [{'name': 'Hospice Decision Aids', 'type': 'OTHER', 'description': 'Paper and video hospice decision aid', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Daniel Matlock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}