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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04727567
Other study ID # IRB00082498
Secondary ID 04-20-10E
Status Completed
Phase
First received
Last updated
Start date April 23, 2020
Est. completion date August 31, 2021

Study information

Verified date September 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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: 1. customized care plan developed for each patient at the time of enrollment 2. routine, virtual health monitoring and collaborative care management team-based review 3. personalized navigation and coordination across multidisciplinary Atrium Health services, as needed 4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 454
Est. completion date August 31, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Comorbidities and Coexisting Conditions

Locations

Country Name City State
United States Atrium Health - Care Management Program Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of inpatient (IP) hospital encounters over a 12 month period Inpatient encounter is defined as an admission to an Atrium Health acute care hospital 12 months
Secondary Number of inpatient hospital encounters over a 6 month period Inpatient encounter is defined as an admission to an Atrium Health acute care hospital 6 months
Secondary Combined Inpatient and Observational hospital encounters - Atrium only Combined number of IP and OBS encounters at Atrium Health hospitals 6 months
Secondary Combined Inpatient and Observational hospital encounters - non-Atrium included Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals 6 months
Secondary Combined Inpatient and Observational hospital encounters - Atrium only Combined number of IP and OBS encounters at Atrium Health hospitals 12 month
Secondary Combined Inpatient and Observational hospital encounters - non-Atrium included Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals 12 month
Secondary Inpatient Readmission Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital 6 month
Secondary Inpatient Readmission Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital 12 month
Secondary Inpatient Readmission - Same Hospital 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 6 month
Secondary Inpatient Readmission - Same Hospital 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 12 month
Secondary Emergency Department Encounters Number of patient emergency department encounters 6 month
Secondary Emergency Department Encounters Number of patient emergency department encounters 12 month
Secondary Mortality Dichotomous indicator of all-cause mortality within 6 months from the beginning of the study period 6 month
Secondary Mortality Dichotomous indicator of all-cause mortality within 12 months from the beginning of the study period 12 month
Secondary Hospital Bed Days (Inpatient) Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization 6 month
Secondary Hospital Bed Days (Inpatient) Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization 12 month
Secondary Hospital Charges Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities. 6 month
Secondary Hospital Charges Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities. 12 month
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