NCT05567224

Brief Summary

Healthcare systems and insurers have tried to reduce costs by improving the care and coordination provided to patients with high healthcare spending. Often termed, "hotspotting", these interventions seek to lower costs by reducing care provided in fragmented, high-cost settings, including the emergency department and inpatient settings, by addressing the social determinants of health and improving patients' access to lower-cost, ambulatory settings. Vanderbilt University Medical Center (VUMC), in collaboration with Tennessee's Medicaid agency (TennCare), is piloting a program to reduce costs and improve the quality of care provided to high-risk TennCare enrollees by referring them from inpatient settings to VUMC primary care services. This study seeks to evaluate this pilot by comparing outcomes between Medicaid patients referred to VUMC primary care services and similar Medicaid patients not referred to VUMC primary care services using data from surveys and administrative sources, including electronic health records and health insurance claims.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

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

First Submitted

Initial submission to the registry

September 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

September 30, 2022

Last Update Submit

April 28, 2025

Conditions

Keywords

Health Care CostsHospitalizationsEmergency Department UseHealth Care AccessibilityMedicaidLow-income populations

Outcome Measures

Primary Outcomes (1)

  • Number of Inpatient Admissions

    How many times the participant is hospitalized within the specified time period

    30, 60, 90, 180, and 360 days

Secondary Outcomes (5)

  • Number of Emergency Department Visits

    30, 60, 90, 180, and 360 days

  • Number of Primary Care Visits

    30, 60, 90, 180, and 360 days

  • Average Health Care Spending

    30, 60, 90, 180, and 360 days

  • Average Self-reported Health Status

    30, 60, 90, 180, and 360 days

  • Average of Disease Specific Outcomes

    30, 60, 90, 180, and 360 days

Study Arms (2)

Pilot Group

This group of TennCare recipients will be referred to VUMC primary care services and will be allowed to utilize these services for at least two years. Those referred to VUMC primary care services will be those who belong to the two of state's three Medicaid Managed Care plans who have agreed to participate in this pilot.

Other: Access to primary care services

Control Group

This group of TennCare recipients will not be referred to VUMC primary care services and will receive care as usual. Those not referred to VUMC primary care services will be those who belong to one of the state's three Medicaid Managed Care plans who has not agreed to participate in this pilot.

Interventions

Those in the pilot group will be referred to primary care services and allowed to utilize them for at least two years. Primary care services include access to a primary care physician, medical management, and other tasks typically performed by a general practitioner. Those referred to primary care services will not have access to other VUMC outpatient services.

Pilot Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients age 18 or older who are currently enrolled in Tennesee's Medicaid program (TennCare) and who are presenting in VUMC's inpatient setting, and who report no active relationship with a primary care doctor.

You may qualify if:

  • Age 18 or older
  • Currently enrolled in Tennessee's Medicaid Program (TennCare)
  • Presenting in VUMC's inpatient setting
  • Reporting no active relationship with a primary care doctor
  • Lives in Davidson County, Tennessee, or a surrounding county

You may not qualify if:

  • Patients discharged to a setting other than the community (e.g. to a Skilled Nursing Facility)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Health Policy

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 5, 2022

Study Start

December 15, 2022

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations