- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567224
Connecting Low-Income Adults to Primary Care After Inpatient Discharge
April 28, 2025 updated by: CARRIE FRY, Vanderbilt University Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
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
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
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
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients discharged to a setting other than the community (e.g. to 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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Inpatient Admissions
Time Frame: 30, 60, 90, 180, and 360 days
|
How many times the participant is hospitalized within the specified time period
|
30, 60, 90, 180, and 360 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Emergency Department Visits
Time Frame: 30, 60, 90, 180, and 360 days
|
How many times the participant presents to the emergency department within the specified time period
|
30, 60, 90, 180, and 360 days
|
|
Number of Primary Care Visits
Time Frame: 30, 60, 90, 180, and 360 days
|
How many times the participant has seen a primary care physician within the specified time period
|
30, 60, 90, 180, and 360 days
|
|
Average Health Care Spending
Time Frame: 30, 60, 90, 180, and 360 days
|
Health care expenditures by the patient within the specified time frame
|
30, 60, 90, 180, and 360 days
|
|
Average Self-reported Health Status
Time Frame: 30, 60, 90, 180, and 360 days
|
A measure of the patient's self-reported physical and mental health, as measured by a shorter, modified version of the Short Form (SF)-36
|
30, 60, 90, 180, and 360 days
|
|
Average of Disease Specific Outcomes
Time Frame: 30, 60, 90, 180, and 360 days
|
Depending on the clinical information that is captured, disease specific clinical outcomes (e.g.
prevalence of hypertension; HbA1C levels) will also be reported
|
30, 60, 90, 180, and 360 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 15, 2022
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 5, 2022
Study Record Updates
Last Update Posted (Actual)
April 29, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 221128
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
product manufactured in and exported from the U.S.
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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