- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727567
Evaluation of a Personalized Care Management Program for High Hospital Utilizers
Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
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.
Population 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:
- customized 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
- education, health coaching, and support via telephonic and in-person interactions, as needed
The control group will receive usual care.
Upon 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Atrium Health - Care Management Program
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- 4 or more inpatient hospital visits across Atrium Health Metro hospitals in 2019
Exclusion Criteria:
- Existing MVP participants
- Patients who at the time of identification for the MVP program are:
- Actively enrolled in a Levine Cancer Institute oncology navigation program
- Actively receiving hospice or palliative care
- Attributed to a primary care provider at an outside healthcare system
- Patients whose primary residence is a skilled nursing facility
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple Visit Patient (MVP) Program
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: customized 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. Education, health coaching, and support via telephonic and in-person interactions, as needed. |
Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of inpatient (IP) hospital encounters over a 12 month period
Time Frame: 12 months
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Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of inpatient hospital encounters over a 6 month period
Time Frame: 6 months
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Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
|
6 months
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Combined Inpatient and Observational hospital encounters - Atrium only
Time Frame: 6 months
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Combined number of IP and OBS encounters at Atrium Health hospitals
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6 months
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Combined Inpatient and Observational hospital encounters - non-Atrium included
Time Frame: 6 months
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Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals
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6 months
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Combined Inpatient and Observational hospital encounters - Atrium only
Time Frame: 12 month
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Combined number of IP and OBS encounters at Atrium Health hospitals
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12 month
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Combined Inpatient and Observational hospital encounters - non-Atrium included
Time Frame: 12 month
|
Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals
|
12 month
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Inpatient Readmission
Time Frame: 6 month
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Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital
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6 month
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Inpatient Readmission
Time Frame: 12 month
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Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital
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12 month
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Inpatient Readmission - Same Hospital
Time Frame: 6 month
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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
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6 month
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Inpatient Readmission - Same Hospital
Time Frame: 12 month
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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
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12 month
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Emergency Department Encounters
Time Frame: 6 month
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Number of patient emergency department encounters
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6 month
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Emergency Department Encounters
Time Frame: 12 month
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Number of patient emergency department encounters
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12 month
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Mortality
Time Frame: 6 month
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Dichotomous indicator of all-cause mortality within 6 months from the beginning of the study period
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6 month
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Mortality
Time Frame: 12 month
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Dichotomous indicator of all-cause mortality within 12 months from the beginning of the study period
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12 month
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Hospital Bed Days (Inpatient)
Time Frame: 6 month
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Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
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6 month
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Hospital Bed Days (Inpatient)
Time Frame: 12 month
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Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
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12 month
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Hospital Charges
Time Frame: 6 month
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Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
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6 month
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Hospital Charges
Time Frame: 12 month
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Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
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12 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Alica Sparling, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00082498
- 04-20-10E (Other Identifier: Atrium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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