NCT04727567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

April 22, 2022

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

January 12, 2021

Last Update Submit

April 14, 2022

Conditions

Keywords

Patient Care ManagementPatient Hospital Admissions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Number of inpatient hospital encounters over a 6 month period

    6 months

  • Combined Inpatient and Observational hospital encounters - Atrium only

    6 months

  • Combined Inpatient and Observational hospital encounters - non-Atrium included

    6 months

  • Combined Inpatient and Observational hospital encounters - Atrium only

    12 month

  • Combined Inpatient and Observational hospital encounters - non-Atrium included

    12 month

  • +12 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • years of age or older
  • or more inpatient hospital visits across Atrium Health Metro hospitals in 2019

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health - Care Management Program

Charlotte, North Carolina, 28203, United States

Location

Study Officials

  • Alica Sparling, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 27, 2021

Study Start

April 23, 2020

Primary Completion

May 1, 2021

Study Completion

August 31, 2021

Last Updated

April 22, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations