Clinical trial NCT04727567: Evaluation of a Personalized Care Management Program for High Hospital Utilizers
Official title: Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbidities and Coexisting Conditions
Keywords: Patient Care Management
Patient Hospital Admissions
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of inpatient (IP) hospital encounters over a 12 month period
timeFrame: 12 months
Secondary outcomes:
measure: Number of inpatient hospital encounters over a 6 month period
timeFrame: 6 months
measure: Combined Inpatient and Observational hospital encounters - Atrium only
timeFrame: 6 months
measure: Combined Inpatient and Observational hospital encounters - non-Atrium included
timeFrame: 6 months
measure: Combined Inpatient and Observational hospital encounters - Atrium only
timeFrame: 12 month
measure: Combined Inpatient and Observational hospital encounters - non-Atrium included
timeFrame: 12 month
measure: Inpatient Readmission
timeFrame: 6 month
measure: Inpatient Readmission
timeFrame: 12 month
measure: Inpatient Readmission - Same Hospital
timeFrame: 6 month
measure: Inpatient Readmission - Same Hospital
timeFrame: 12 month
measure: Emergency Department Encounters
timeFrame: 6 month
measure: Emergency Department Encounters
timeFrame: 12 month
measure: Mortality
timeFrame: 6 month
measure: Mortality
timeFrame: 12 month
measure: Hospital Bed Days (Inpatient)
timeFrame: 6 month
measure: Hospital Bed Days (Inpatient)
timeFrame: 12 month
measure: Hospital Charges
timeFrame: 6 month
measure: Hospital Charges
timeFrame: 12 month
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health - Care Management Program
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Alica Sparling, PhD
role: PRINCIPAL_INVESTIGATOR
References: