Evaluation of a Personalized Care Management Program for High Hospital Utilizers

April 14, 2022 updated by: Wake Forest University Health Sciences

Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

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:

  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.

Study Type

Observational

Enrollment (Actual)

454

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health - Care Management Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

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
Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of inpatient hospital encounters over a 6 month period
Time Frame: 6 months
Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Time Frame: 6 months
Combined number of IP and OBS encounters at Atrium Health hospitals
6 months
Combined Inpatient and Observational hospital encounters - non-Atrium included
Time Frame: 6 months
Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals
6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Time Frame: 12 month
Combined number of IP and OBS encounters at Atrium Health hospitals
12 month
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
Inpatient Readmission
Time Frame: 6 month
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
Inpatient Readmission
Time Frame: 12 month
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
Inpatient Readmission - Same Hospital
Time Frame: 6 month
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
Inpatient Readmission - Same Hospital
Time Frame: 12 month
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
Emergency Department Encounters
Time Frame: 6 month
Number of patient emergency department encounters
6 month
Emergency Department Encounters
Time Frame: 12 month
Number of patient emergency department encounters
12 month
Mortality
Time Frame: 6 month
Dichotomous indicator of all-cause mortality within 6 months from the beginning of the study period
6 month
Mortality
Time Frame: 12 month
Dichotomous indicator of all-cause mortality within 12 months from the beginning of the study period
12 month
Hospital Bed Days (Inpatient)
Time Frame: 6 month
Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
6 month
Hospital Bed Days (Inpatient)
Time Frame: 12 month
Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
12 month
Hospital Charges
Time Frame: 6 month
Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
6 month
Hospital Charges
Time Frame: 12 month
Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alica Sparling, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

September 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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