Health Care UtilizationNCT05567224
Connecting Low-Income Adults to Primary Care After Inpatient Discharge
An observational study of Health Care Utilization and Health Care Seeking Behavior, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Utilization, Health Care Seeking Behavior
- What is being tested?
- Access to primary care services
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients discharged to a setting other than the community (e.g. to a Skilled Nursing Facility)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
- Being tested
- Access to primary care services
- Keywords
- Health Care Costs, Hospitalizations, Emergency Department Use, Health Care Accessibility, Medicaid, Low-income populations
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to primary care servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Inpatient Admissions
How many times the participant is hospitalized within the specified time period
Measured: 30, 60, 90, 180, and 360 days
Secondary outcomes (5)
Number of Emergency Department Visits
How many times the participant presents to the emergency department within the specified time period
Measured: 30, 60, 90, 180, and 360 days
Number of Primary Care Visits
How many times the participant has seen a primary care physician within the specified time period
Measured: 30, 60, 90, 180, and 360 days
Average Health Care Spending
Health care expenditures by the patient within the specified time frame
Measured: 30, 60, 90, 180, and 360 days
Average Self-reported Health Status
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
Measured: 30, 60, 90, 180, and 360 days
Average of Disease Specific Outcomes
Depending on the clinical information that is captured, disease specific clinical outcomes (e.g. prevalence of hypertension; HbA1C levels) will also be reported
Measured: 30, 60, 90, 180, and 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start15 Dec 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARRIE FRY, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567224
- Sponsor's protocol ID
- 221128
- Status last verified
- Feb 2025
- First submitted
- 30 Sep 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Low-Income Adults to Primary Care After Inpatient Discharge
- ClinicalTrials.gov ID
- NCT05567224
- Acronym / sponsor ID
- 221128
- Keywords
- Health Care Costs, Hospitalizations, Emergency Department Use, Health Care Accessibility, Medicaid, Low-income populations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | – | Other: Access to primary care servicesThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients discharged to a setting other than the community (e.g. to a Skilled Nursing Facility)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to primary care servicesThose 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. | Other | Pilot Group |
Primary outcome
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
5 secondary outcomes
Number of Emergency Department Visits
Time frame: 30, 60, 90, 180, and 360 days
Number of Primary Care Visits
Time frame: 30, 60, 90, 180, and 360 days
Average Health Care Spending
Time frame: 30, 60, 90, 180, and 360 days
Average Self-reported Health Status
Time frame: 30, 60, 90, 180, and 360 days
Average of Disease Specific Outcomes
Time frame: 30, 60, 90, 180, and 360 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Utilization and Health Care Seeking Behavior, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Inpatient Admissions (time frame: 30, 60, 90, 180, and 360 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.