Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-30 @ 3:56 AM
Study NCT ID:
NCT04778761
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACP Video Intervention for Patients With Life-Limiting Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The research team collecting study outcomes will be blinded to group assignment'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost of care in the last year of life', 'timeFrame': '1 year', 'description': 'Compare cost of care in the last year of life between the study groups'}], 'primaryOutcomes': [{'measure': 'Hospice utilization', 'timeFrame': 'up to one year follow-up or death', 'description': 'Compare the use of hospice (yes vs. no) between the study groups'}], 'secondaryOutcomes': [{'measure': 'Hospice length of stay', 'timeFrame': 'up to one year follow-up or death', 'description': 'Compare hospice length-of-stay between the study groups'}, {'measure': 'Rates of documented resuscitation preferences in the Electronic Health Record', 'timeFrame': 'up to one year follow-up or death', 'description': 'Compare documented resuscitation preferences in the Electronic Health Record between the two groups'}, {'measure': 'Rates of Advance Care Planning documentation in the Electronic Health Record', 'timeFrame': 'up to one year follow-up or death', 'description': 'Compare advance care planning documentation in the Electronic Health Record between the two groups'}, {'measure': 'Patient knowledge about Advance Care Planning', 'timeFrame': 'Up to two days following the intervention visit', 'description': "Compare patient's knowledge about advance care planning using a 5-item knowledge questionnaire (range 0-5), higher score indicate more knowledge"}, {'measure': 'Patient reported confidence in care', 'timeFrame': 'up to two days following the intervention visit', 'description': "Compare patient's reported confidence in their medical care using a single Likert response question between the two study groups. Score range from 0-4. Higher scores indicate higher confidence in care"}, {'measure': 'Patient reported satisfaction with clinician communication', 'timeFrame': 'up to two days following the intervention visit', 'description': 'Compare patient satisfaction with their communication with their clinician using the CAHPS subscale. Score range 0-20. Higher score indicate better satisfaction with communication'}, {'measure': 'Patient reported decisional satisfaction', 'timeFrame': 'up to two days following the intervention visit', 'description': 'Compare patient reported decisional satisfaction between the study groups using the Satisfaction with Decision Scale. Scale range from 6-30. Higher scores indicate higher satisfaction with decision'}, {'measure': 'Patient reported decisional certainty', 'timeFrame': 'up to two days following the intervention visit', 'description': 'Compare patient reported decisional certainty between the two groups using the Decision Conflict Scale. Score ranges from 0 to 100. Higher scores indicate higher decisional conflict'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Care Utilization', 'End Stage Disease']}, 'descriptionModule': {'briefSummary': "The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.", 'detailedDescription': 'ACP is a process that allows patients to communicate their wishes and preferences or medical care, when they are seriously ill, to their medical providers. The study investigators would like to assess whether a home-ACP video can improve patient-clinician communication about patients wishes for their medical care and lead to more patient-centered care.\n\nThis study is a randomized clinical trial of a Home-ACP intervention among 500 adult patients with serious illness receiving medical care at home with the Clover Health House Calls Program. Study participants will be assigned to one of two groups. In one group, participants will continue to receive usual care with their home-based care team. In the second group, participants will continue to receive their usual care with their home-based care team and also view an ACP video that helps them understand ACP and provides education about ACP and hospice care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 21 or over\n* Have a one-year prognosis or less as determined by Clover Health's validated algorithm\n* Speak either English or one of the other 25 languages in which the video intervention is available\n\nExclusion Criteria:\n\n* Visually impaired beyond 20/200 corrected\n* Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider."}, 'identificationModule': {'nctId': 'NCT04778761', 'briefTitle': 'ACP Video Intervention for Patients With Life-Limiting Illness', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Randomized Trial of a Home-Advance Care Planning Video Intervention for Patients With Life-Limiting Illness', 'orgStudyIdInfo': {'id': '2020P001277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care entails receiving usual medical care by the home-based care team.'}, {'type': 'EXPERIMENTAL', 'label': 'Video intervention', 'description': 'In addition to usual care, the intervention will entail having a visit by a trained study clinician to provide access to the ACP video. The study clinician will discuss the content of the video and answer any questions.', 'interventionNames': ['Behavioral: Home ACP Video']}], 'interventions': [{'name': 'Home ACP Video', 'type': 'BEHAVIORAL', 'description': 'A video focused on Advance Care Planning and Hospice for patients with serious illness', 'armGroupLabels': ['Video intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07302', 'city': 'Jersey City', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kumar Dharmarajian, MD', 'role': 'CONTACT'}], 'facility': 'Clover Health', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}], 'centralContacts': [{'name': 'Areej El-Jawahri, MD', 'role': 'CONTACT', 'email': 'ael-jawahri@partners.org', 'phone': '617-724-4000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Of Medicine', 'investigatorFullName': 'El-Jawahri, Areej,M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}