Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-29 @ 12:31 AM
Study NCT ID:
NCT04727567
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Personalized Care Management Program for High Hospital Utilizers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-13', 'size': 286385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-13T13:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of inpatient (IP) hospital encounters over a 12 month period', 'timeFrame': '12 months', 'description': 'Inpatient encounter is defined as an admission to an Atrium Health acute care hospital'}], 'secondaryOutcomes': [{'measure': 'Number of inpatient hospital encounters over a 6 month period', 'timeFrame': '6 months', 'description': 'Inpatient encounter is defined as an admission to an Atrium Health acute care hospital'}, {'measure': 'Combined Inpatient and Observational hospital encounters - Atrium only', 'timeFrame': '6 months', 'description': 'Combined number of IP and OBS encounters at Atrium Health hospitals'}, {'measure': 'Combined Inpatient and Observational hospital encounters - non-Atrium included', 'timeFrame': '6 months', 'description': 'Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals'}, {'measure': 'Combined Inpatient and Observational hospital encounters - Atrium only', 'timeFrame': '12 month', 'description': 'Combined number of IP and OBS encounters at Atrium Health hospitals'}, {'measure': 'Combined Inpatient and Observational hospital encounters - non-Atrium included', 'timeFrame': '12 month', 'description': 'Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals'}, {'measure': 'Inpatient Readmission', 'timeFrame': '6 month', 'description': 'Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital'}, {'measure': 'Inpatient Readmission', 'timeFrame': '12 month', 'description': 'Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital'}, {'measure': 'Inpatient Readmission - Same Hospital', 'timeFrame': '6 month', 'description': 'Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to the same AH hospital as the index encounter'}, {'measure': 'Inpatient Readmission - Same Hospital', 'timeFrame': '12 month', 'description': 'Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to the same AH hospital as the index encounter'}, {'measure': 'Emergency Department Encounters', 'timeFrame': '6 month', 'description': 'Number of patient emergency department encounters'}, {'measure': 'Emergency Department Encounters', 'timeFrame': '12 month', 'description': 'Number of patient emergency department encounters'}, {'measure': 'Mortality', 'timeFrame': '6 month', 'description': 'Dichotomous indicator of all-cause mortality within 6 months from the beginning of the study period'}, {'measure': 'Mortality', 'timeFrame': '12 month', 'description': 'Dichotomous indicator of all-cause mortality within 12 months from the beginning of the study period'}, {'measure': 'Hospital Bed Days (Inpatient)', 'timeFrame': '6 month', 'description': 'Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization'}, {'measure': 'Hospital Bed Days (Inpatient)', 'timeFrame': '12 month', 'description': 'Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization'}, {'measure': 'Hospital Charges', 'timeFrame': '6 month', 'description': 'Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.'}, {'measure': 'Hospital Charges', 'timeFrame': '12 month', 'description': 'Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Care Management', 'Patient Hospital Admissions'], 'conditions': ['Comorbidities and Coexisting Conditions']}, 'descriptionModule': {'briefSummary': "This randomized clinical trial intends to evaluate the effectiveness of enrollment in Atrium Health's Multiple Visit Patient (MVP) care management program compared to usual care on reducing 12-month total inpatient hospital utilization among patients with high past volume of hospital inpatient stays.", 'detailedDescription': "The list of patients with four or more inpatient hospital visits in 2019 will be pulled from the Atrium Health electronic data warehouse (EDW) by IAS Clinical Quality Analytics, and eligibility for the MVP program of patients on this list will be determined by the Population Health's Care Management team based on predefined eligibility criteria. IAS CORE will randomize eligible participants into one of two groups: 1) MVP program; or 2) usual care.\n\nPopulation Health's Multiple Visit Patient (MVP) care management program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components:\n\n1. customized care plan developed for each patient at the time of enrollment\n2. routine, virtual health monitoring and collaborative care management team-based review\n3. personalized navigation and coordination across multidisciplinary Atrium Health services, as needed\n4. education, health coaching, and support via telephonic and in-person interactions, as needed\n\nThe control group will receive usual care.\n\nUpon completion of the 12-month period during which outcomes data will be accrued, the study will evaluate whether 12-month participation in the MVP program care management program, compared to usual care, reduced inpatient hospital use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included in the evaluable population for this project, will have their data inform the final outcomes assessment. All patients who meet the inclusion and exclusion criteria in both groups will be assessed for the primary outcome (intent to treat).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* 4 or more inpatient hospital visits across Atrium Health Metro hospitals in 2019\n\nExclusion Criteria:\n\n* Existing MVP participants\n* Patients who at the time of identification for the MVP program are:\n* Actively enrolled in a Levine Cancer Institute oncology navigation program\n* Actively receiving hospice or palliative care\n* Attributed to a primary care provider at an outside healthcare system\n* Patients whose primary residence is a skilled nursing facility'}, 'identificationModule': {'nctId': 'NCT04727567', 'briefTitle': 'Evaluation of a Personalized Care Management Program for High Hospital Utilizers', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB00082498'}, 'secondaryIdInfos': [{'id': '04-20-10E', 'type': 'OTHER', 'domain': 'Atrium'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Visit Patient (MVP) Program', 'description': 'The MVP program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components:\n\ncustomized care plan developed for each patient at the time of enrollment routine, virtual health monitoring and collaborative care management team-based review personalized navigation and coordination across multidisciplinary Atrium Health services, as needed.\n\nEducation, health coaching, and support via telephonic and in-person interactions, as needed.'}, {'label': 'Usual Care', 'description': "Atrium Health standard of care. Patient's post-discharge usual care depends on the inpatient care management assessment at last hospital admission. Patients can be discharged to home and receive no further care, or home with home health, or to a skilled nursing facility (SNF) or another type of Continuing Care facility. Patients can be referred to advanced illness management, hospice, and Community Care Partners by the inpatient care manager. Patient can be referred to Ambulatory Care Management for care management also via telehealth, by a primary care physician or the Transitions Clinic."}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health - Care Management Program', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Alica Sparling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}