Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-03-02 @ 10:35 PM
Study NCT ID:
NCT03609658
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2018-07-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Integrated Multidisciplinary Patient and Family Advance Care Planning Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgabbard@wakehealth.edu', 'phone': '336-716-8028', 'title': 'Jennifer Gabbard, M.D.', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Month 1 through Month 12', 'description': 'Usual Care Group did not sign consent. No Adverse Events (AEs)/Serious Adverse Events (SAEs)/All-Cause Mortality data was collected for that arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.", 'otherNumAtRisk': 379, 'deathsNumAtRisk': 379, 'otherNumAffected': 0, 'seriousNumAtRisk': 379, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator", 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.', 'unitOfMeasure': 'Discussions', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome includes all randomized subjects (Zelen's design)."}, {'type': 'PRIMARY', 'title': "Number of Patient's Documented Advance Care Planning Discussions - Provider", 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of documentations completed in the newly created ACP note template for provider note templates.', 'unitOfMeasure': 'discussions', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome applies to randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Quality of Advance Care Planning Discussion - Nurse Navigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the newly created ACP note template for both nurse navigator (score ranging from 0-8). Score of 5 or higher determines better outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Quality of Advance Care Planning Discussion - Provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the newly created ACP note template for provider note templates (score ranging from 0-15). Score of 8 or higher in the provider template determines better outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not collected for this outcome'}, {'type': 'PRIMARY', 'title': "Quality of Advance Care Planning Discussion From the Patient's Perspective", 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'title': 'General Communication', 'categories': [{'measurements': [{'value': '10.2', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'End of Life', 'categories': [{'measurements': [{'value': '7.9', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the Quality about End of Life (EOL) Communication (QOC), The instrument is reported as 2 subscales: "general communication skills" and "communication about end-of-life care." Score range for the subscales is 1-11 Higher scores determine better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome does not apply to usual care group. Ten subjects were lost to follow up and 5 subjects withdrew consent from Nurse Navigator arm. Completion of the QOC was optional for the participants who had completed the provider visit.'}, {'type': 'SECONDARY', 'title': 'Advance Care Planning Billing Code Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Month 13)', 'description': 'ACP billing codes: 99497 and 99498 usages will be recorded', 'unitOfMeasure': 'code usages', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome uses all randomized subjects (Zelen's Design)."}, {'type': 'SECONDARY', 'title': 'Number of Designated Surrogate Decision Makers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).', 'unitOfMeasure': 'surrogate decision makers', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome uses all randomized (Zelen's Design)."}, {'type': 'SECONDARY', 'title': 'Advance Directive Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of scanned advance directive documents in the EHR.', 'unitOfMeasure': 'scanned documents', 'reportingStatus': 'POSTED', 'populationDescription': "Based on all randomized (Zelen's Design)."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Medical Scope of Treatment (MOST) Discussions', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'After-death Bereaved Family Member Interview', 'timeFrame': 'Month 29', 'description': 'The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Patient Healthcare Utilization', 'timeFrame': 'End of Study (Month 13)', 'description': 'Frequency is measured by the number of healthcare events recorded in the EHR.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost of Patient Healthcare Utilization', 'timeFrame': 'End of Study (Month 13)', 'description': 'Cost of patient healthcare utilization per group', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Provider Satisfaction With the Intervention Scale', 'timeFrame': 'Month 11', 'description': 'This is a likert scale total score (0-78). Higher scores denotes better outcomes', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Protocol Deviations', 'timeFrame': 'End of Study (Month 13)', 'description': 'The number of protocol deviations will be reported to measure the fidelity of study implementation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Usability of the ACP Documentation Tool (ACPWiseTool)', 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the System Usability Scale (SUS) survey. Likert Scale of strongly disagree, disagree, neutral, agree, and strongly agree. Score ranges from 1 to 5. Higher score equates higher usability.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "This protocol has Zelen's Design. Subjects were randomized to either the usual care arm or the nurse navigator arm prior to signing consent. And only those who were randomized to nurse navigator arm were consented. 379 subjects randomized to the nurse navigator arm, and of those, only 146 agreed to participate and signed consent. Subjects randomized to the usual care arm had a waiver of consent. The study team only did chart analysis for usual care subjects."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nurse Navigator Pathway Group', 'description': "Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)\n\nNurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion."}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).\n\nUsual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '65 to <75 years', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}, {'title': '75 to <85 years', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}, {'title': '≥85 years', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}]}]}, {'title': 'black', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Analysis Population includes all randomized subjects prior to signing consent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-11', 'size': 901016, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-08T14:57', 'hasProtocol': True}, {'date': '2018-11-12', 'size': 132554, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-08T16:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two groups. All participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group. Note that patients that do not consent to the intervention are still counted as part of control group under an intent-to-treat paradigm, which necessitates passive ascertainment mechanisms for outcomes (i.e. administrative claims or the EHR).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2018-07-25', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-14', 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Medical Scope of Treatment (MOST) Discussions', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR'}, {'measure': 'After-death Bereaved Family Member Interview', 'timeFrame': 'Month 29', 'description': 'The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.'}, {'measure': 'Frequency of Patient Healthcare Utilization', 'timeFrame': 'End of Study (Month 13)', 'description': 'Frequency is measured by the number of healthcare events recorded in the EHR.'}, {'measure': 'Cost of Patient Healthcare Utilization', 'timeFrame': 'End of Study (Month 13)', 'description': 'Cost of patient healthcare utilization per group'}, {'measure': 'Provider Satisfaction With the Intervention Scale', 'timeFrame': 'Month 11', 'description': 'This is a likert scale total score (0-78). Higher scores denotes better outcomes'}, {'measure': 'Number of Protocol Deviations', 'timeFrame': 'End of Study (Month 13)', 'description': 'The number of protocol deviations will be reported to measure the fidelity of study implementation.'}, {'measure': 'Usability of the ACP Documentation Tool (ACPWiseTool)', 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the System Usability Scale (SUS) survey. Likert Scale of strongly disagree, disagree, neutral, agree, and strongly agree. Score ranges from 1 to 5. Higher score equates higher usability.'}], 'primaryOutcomes': [{'measure': "Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator", 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.'}, {'measure': "Number of Patient's Documented Advance Care Planning Discussions - Provider", 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of documentations completed in the newly created ACP note template for provider note templates.'}, {'measure': 'Quality of Advance Care Planning Discussion - Nurse Navigator', 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the newly created ACP note template for both nurse navigator (score ranging from 0-8). Score of 5 or higher determines better outcome.'}, {'measure': 'Quality of Advance Care Planning Discussion - Provider', 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the newly created ACP note template for provider note templates (score ranging from 0-15). Score of 8 or higher in the provider template determines better outcome.'}, {'measure': "Quality of Advance Care Planning Discussion From the Patient's Perspective", 'timeFrame': 'End of Study (Month 13)', 'description': 'Measured by the Quality about End of Life (EOL) Communication (QOC), The instrument is reported as 2 subscales: "general communication skills" and "communication about end-of-life care." Score range for the subscales is 1-11 Higher scores determine better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Advance Care Planning Billing Code Usage', 'timeFrame': 'End of Study (Month 13)', 'description': 'ACP billing codes: 99497 and 99498 usages will be recorded'}, {'measure': 'Number of Designated Surrogate Decision Makers', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).'}, {'measure': 'Advance Directive Completion', 'timeFrame': 'End of Study (Month 13)', 'description': 'Reported as the number of scanned advance directive documents in the EHR.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vulnerable Older Adults', 'Nurse Navigator', 'Usual Care', 'Family', 'Multimorbid patients'], 'conditions': ['Advance Care Planning']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'U.S. Census Bureau. International database. Table 094. Midyear population, by age and sex. Available at http://www.census.gov/population/www/projections/natdet-D1A.htmlExternal Web Site Icon.'}, {'pmid': '24403380', 'type': 'BACKGROUND', 'citation': 'Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Espinosa J, Constante C, Mitchell GK. Prevalence and characteristics of patients with advanced chronic conditions in need of palliative care in the general population: a cross-sectional study. Palliat Med. 2014 Apr;28(4):302-11. doi: 10.1177/0269216313518266. Epub 2014 Jan 8.'}, {'type': 'BACKGROUND', 'citation': '"Methods for Analysis of the Financing and Use of Long-Term Services and Supports," supplemental material for Rising Demand for Long-Term Services and Supports for Elderly People (June 2013), www.cbo.gov/publication/44370.'}, {'pmid': '26885757', 'type': 'BACKGROUND', 'citation': 'Schoenborn NL, Cayea D, McNabney M, Ray A, Boyd C. 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BMJ Open. 2019 Dec 15;9(12):e032732. doi: 10.1136/bmjopen-2019-032732.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ways to engage sick patients and their family members in Advance Care Planning (ACP) discussions. Two pathways will be tested, discussions using a Nurse Navigator led pathway versus usual care.', 'detailedDescription': "This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to engage multimorbid patients and their family members in Advance Care Planning through a Nurse Navigator led pathway versus usual care. Investigators propose to utilize Zelen's design (a more recent label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT), a pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 or older patient within the Wake Forest/Cornerstone ACO\n* Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 months\n* English speaking\n* No documented Advance Directive in the EHR\n* Impairments in either physical function, cognition, and/or frailty\n\nExclusion Criteria:\n\n* No available proxy (e.g. in setting of cognitive impairment)\n* Severe/advanced dementia\n* Moderate to severe hearing loss\n* Non-English speaking\n* No phone number available for patient'}, 'identificationModule': {'nctId': 'NCT03609658', 'acronym': 'IMPACT', 'briefTitle': 'Integrated Multidisciplinary Patient and Family Advance Care Planning Trial', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)', 'orgStudyIdInfo': {'id': 'IRB00049370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse Navigator Pathway Group', 'description': 'Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)', 'interventionNames': ['Behavioral: Nurse Navigator Pathway']}, {'type': 'SHAM_COMPARATOR', 'label': 'Usual Care Group', 'description': 'Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Nurse Navigator Pathway', 'type': 'BEHAVIORAL', 'description': "In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.", 'armGroupLabels': ['Nurse Navigator Pathway Group']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.', 'armGroupLabels': ['Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27203', 'city': 'Asheboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Family & Community Medicine of Asheboro', 'geoPoint': {'lat': 35.70791, 'lon': -79.81364}}, {'zip': '28610', 'city': 'Claremont', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Claremont Family Medicine', 'geoPoint': {'lat': 35.71458, 'lon': -81.14619}}, {'zip': '28613', 'city': 'Conover', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Conover Family Practice', 'geoPoint': {'lat': 35.70652, 'lon': -81.21869}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chronic Complex Care', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cornerstone Internal Medicine at Westchester', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'High Point Family Practice', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27360', 'city': 'Thomasville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Thomasville Family Practice', 'geoPoint': {'lat': 35.88264, 'lon': -80.08199}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Downtown Health Plaza', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Jennifer Gabbard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}