Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-24 @ 2:30 PM
Study NCT ID:
NCT03508557
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2018-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing Advance Care Planning Conversation Tools in Family Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group before-after'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinician experience of intervention', 'timeFrame': '6 months', 'description': 'survey of clinician experience using conversation tools'}, {'measure': 'Clinician confidence having advance care planning conversations', 'timeFrame': '6 months', 'description': 'survey of clinician confidence, satisfaction'}], 'primaryOutcomes': [{'measure': 'Advance care planning engagement', 'timeFrame': '12 weeks', 'description': 'Survey measuring domains of engagement in advance care planning'}], 'secondaryOutcomes': [{'measure': 'Advance care planning engagement-substitute decision maker', 'timeFrame': '12 weeks', 'description': 'survey measuring substitute decision maker domains of engagement in advance care planning'}, {'measure': 'Patient experience', 'timeFrame': '12 weeks', 'description': 'survey of patient experience with intervention'}, {'measure': 'Patient perceived impact on health care', 'timeFrame': '6-9 months', 'description': 'qualitative interviews of patients asking perceived impact of intervention on later health care use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frail Elderly Syndrome', 'Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '38879532', 'type': 'DERIVED', 'citation': "Stevens J, Elston D, Tan A, Barwich D, Carter RZ, Cochrane D, Frenette N, Howard M. Clinicians' experiences implementing an advance care planning pathway in two Canadian provinces: a qualitative study. BMC Prim Care. 2024 Jun 15;25(1):217. doi: 10.1186/s12875-024-02468-4."}]}, 'descriptionModule': {'briefSummary': "This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.", 'detailedDescription': "Structured tools are helpful for advance care planning. Tools have been developed to help with advance care planning because it is a process which has multiple steps and people involved. This study will help health care teams in primary care learn to use the tools with frail or older seriously ill patients and will evaluate the perceptions of patients, family members and health care providers, as well as the impact of having the discussions on subsequent health care interactions the patient has.\n\nPatients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 60 or older\n* chronic condition that may reduce life expectancy as per physician's clinical judgement\n* able to communicate verbally in English and read English\n\nExclusion Criteria:\n\n* unable to communicate verbally in English\n* unable to read English\n* cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant"}, 'identificationModule': {'nctId': 'NCT03508557', 'briefTitle': 'Implementing Advance Care Planning Conversation Tools in Family Practice', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Implementing Advance Care Planning Conversation Tools in Family Practice', 'orgStudyIdInfo': {'id': 'TG2015-03D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advance care planning tools', 'description': 'Advance care planning education and structured conversation using tools', 'interventionNames': ['Behavioral: Advance care planning tools']}], 'interventions': [{'name': 'Advance care planning tools', 'type': 'BEHAVIORAL', 'description': 'Structured conversations between patients/substitute decision-maker and clinician based on education about advance care planning using locally relevant booklet/website, values clarification tool for patient engagement, clinician use of the Serious Illness Conversation Guide', 'armGroupLabels': ['Advance care planning tools']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T1Y 5S3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Sunridge Family Medicine Teaching Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Langley', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Safa Medical Clinic', 'geoPoint': {'lat': 49.10107, 'lon': -122.65883}}, {'zip': 'V3L 3C2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'New Westminster Family Practice', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital Gordon and Leslie Diamond Health Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Michelle Howard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Frailty Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michelle Howard', 'investigatorAffiliation': 'McMaster University'}}}}