Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-30 @ 5:13 AM
Study NCT ID:
NCT05766956
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is a composite outcome of all-cause mortality', 'timeFrame': '30 days post-discharge', 'description': 'The rate of death'}, {'measure': '30-day readmission', 'timeFrame': '30 days post-discharge', 'description': 'Readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Illness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients, 18 years of age and older\n* Present to one of the participating hospitals\n* Have a chief complaint of one of the target diagnoses\n* Are within a certain geographical area (based on zip codes)\n* Have a health insurance plan that covers ACH services\n* Have the capacity to consent or could assent with the consent of a health care proxy who is physically present\n\nExclusion Criteria:\n\n* Not suitable for ACH or inpatient hospital care as determined by the patient's clinical team\n* Do not have the capacity to consent or assent with the assistance of a health care proxy"}, 'identificationModule': {'nctId': 'NCT05766956', 'briefTitle': 'Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial', 'orgStudyIdInfo': {'id': '22-013387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced Care at Home (ACH)', 'description': 'Patients will receive inpatient hospitalization at home.', 'interventionNames': ['Other: Advanced Care at Home (ACH)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Inpatient (Brick-and-Mortar) Hospital Care', 'description': 'Patients will receive inpatient hospitalization at the hospital.', 'interventionNames': ['Other: Traditional Brick-and-Mortar Hospitalization']}], 'interventions': [{'name': 'Advanced Care at Home (ACH)', 'type': 'OTHER', 'description': 'Inpatient hospitalization offered in the home setting.', 'armGroupLabels': ['Advanced Care at Home (ACH)']}, {'name': 'Traditional Brick-and-Mortar Hospitalization', 'type': 'OTHER', 'description': 'Inpatient hospitalization offered in the hospital setting.', 'armGroupLabels': ['Traditional Inpatient (Brick-and-Mortar) Hospital Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '54703', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael J. Maniaci', 'investigatorAffiliation': 'Mayo Clinic'}}}}