Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04224220
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2020-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1947}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Readmission', 'timeFrame': '30 days', 'description': 'The rate of patients revisiting the emergency department or being admitted to the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Activation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Discharged from the hospital in the past 7 days\n* LACE+ score of 59 or greater and at least two chronic conditions\n* Index hospitalization with discharge directly to community dwelling home (home, assisted living)\n* English speaking\n* Normal cognitive function - mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment\n* Mayo Clinic or Mayo Clinic Health System provider managing the patient's care (e.g. primary care); patient is assigned to the panel of a Mayo Clinic Medical Doctor/Nurse Practitioner/Physician Assistant\n* Access to and ability to communicate via telephone (either patient or caregiver)\n\nExclusion Criteria:\n\n* Psychiatric hospital admission\n* Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient's clinic\n* Untreated active substance or alcohol abuse\n* Dementia or moderate to severe cognitive impairment\n* Discharged to one of the following: rehabilitation unit, skilled nursing facility, assisted living memory unit, group home\n* Pregnancy\n* Active treatment for cancer\n* Receiving dialysis or transplant services\n* Life expectancy \\< 6 months or enrolled in hospice or palliative care programs\n* Patient is unwilling to sign a Release of Information (ROI); ROI allows those providing care, internal and external, to be actively involved in the patient's care coordination\n* Patients with active tuberculosis (TB)\n* Violent patient flag noted in Epic (for adult medical care coordination)\n* Patient declines home visit (for adult medical care coordination)\n* Patient is already enrolled in remote patient monitoring or the care transitions program"}, 'identificationModule': {'nctId': 'NCT04224220', 'briefTitle': 'Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '19-009784'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adult Medical Care Coordination', 'description': 'This group will receive adult medical care coordination following discharge from a recent hospitalization.', 'interventionNames': ['Other: Adult Medical Care Coordination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remote Patient Monitoring', 'description': 'This group will receive remote patient monitoring following discharge from a recent hospitalization.', 'interventionNames': ['Other: Remote Patient Monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'The usual care group will not receive additional supportive care following discharge from a recent hospitalization beyond what is typically offered through their primary care team.'}], 'interventions': [{'name': 'Adult Medical Care Coordination', 'type': 'OTHER', 'description': 'Nurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms.', 'armGroupLabels': ['Adult Medical Care Coordination']}, {'name': 'Remote Patient Monitoring', 'type': 'OTHER', 'description': 'Nurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms.', 'armGroupLabels': ['Remote Patient Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michelle Lampman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle A. Lampman', 'investigatorAffiliation': 'Mayo Clinic'}}}}