- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080595
Transportation Assistance Program for Liver Transplant (TAP-LT)
Pilot Randomized Controlled Trial of a Need-Based Transportation Assistance Program in Liver Transplant Candidates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Transportation barriers are often cited as barriers to healthcare access, leading to delays in care, non-compliance, and lower health outcomes. We hypothesize that access to transportation is a key modifiable social determinant that, if intervened upon, will lead to improvements in equitable access to the liver transplant waitlist (and transplant) for underserved liver transplant candidates.
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.
Aim 1 is to ascertain the prevalence of transportation barriers among liver transplant candidates and describe the sociodemographic and clinical characteristics of this population. Aim 2 is to pilot a randomized controlled trial of the needs-based app-supported transportation assistance program (TAP-LT) intervention. We will also assess preliminary efficacy, feasibility, patient acceptability, and cost of the intervention. We will conduct a prospective observational survey study (Aim 1) and pilot randomized controlled trial (Aim 2) at a single liver transplant program (Keck Liver Transplant Program at Keck Medical Center).
For the interventional trial, we will have three arms (Figure 2). Participants who report transportation barriers will be randomized 1:1 to either TAP-LT intervention or usual care (no transportation resources or assistance provided). Additionally, participants who report a reliable source of transportation will be included as a secondary control. In this pilot trial, we will enroll 20 participants in each of the three arms. We anticipate initiation of recruitment within 2 months of study approval, recruitment over approximately 6 months, with 6-12 months of intervention and follow-up with the goal of at least 90 days of follow-up after the end of intervention period for all recruited participants. The target population is adult liver transplant candidates who do not have a reliable source of transportation for their healthcare-related visits and needs. We will include adult patients who are eligible for liver transplantation and attend an initial outpatient evaluation visit.
The primary endpoint is the proportion of liver transplant candidates who report barriers to transportation. We will compare sociodemographic and clinical characteristics stratified by transportation status using Chi-square or t-test/Kruskal-Wallis as appropriate. Predictors of transportation barriers will be assessed with univariate and multivariate logistic regression. The primary outcome (time to listing for transplant waitlisting) will be a time-to-event outcome and we will examine the effect of the TAP-LT intervention with intention-to-treat Fine and Gray competing risk regression based on treatment arm. Secondary outcomes will be compared using Chi-square or t-test/Kruskal-Wallis as appropriate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Keck Transplant Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18+)
- Attended Phase 1 or Phase 1/2 Liver Transplant clinic visit
Exclusion Criteria:
- Unable to provide informed consent
- Pregnant women or prisoners
- Deemed ineligible for liver transplantation during initial evaluation visit
- Not referred for Phase 2 visit at the time of Phase 1 visit among those with initial Phase 1 visit only
- Hospitalized at the time of initial Phase 1 or Phase1/2 visit
- No access to handheld or landline telephone
- Residence outside of 60 miles from Keck Hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transportation assistance, reports unreliable transportation
Lyft rides provided to transplant-related appointments
|
Lyft rides will be provided to patients for any transplant-related medical visits
|
No Intervention: No transportation assistance, reports unreliable transportation
No intervention, standard-of-care
|
|
No Intervention: Transportation assistance, control
No intervention, standard-of-care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to waitlisting for liver transplant
Time Frame: through study completion, an average of 1 year
|
The primary outcome will be time to waitlisting for liver transplant, defined as time (in days) from initial evaluation visit date to date of official listing for liver transplant in the United Network for Organ Sharing database.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion with reported transportation barriers
Time Frame: 1 year
|
Number of patients who report transportation barriers vs those who don't will be obtained from our transportation barriers survey
|
1 year
|
Proportion waitlisted/transplanted
Time Frame: through study completion, an average of 1 year
|
Proportion waitlisted/transplanted will be obtained from medical records
|
through study completion, an average of 1 year
|
Number of no-shows/cancellations
Time Frame: through study completion, an average of 1 year
|
Number of no-shows/cancellations will be obtained from medical records
|
through study completion, an average of 1 year
|
Number of hospitalizations
Time Frame: through study completion, an average of 1 year
|
Number of hospitalizations will be obtained from medical records
|
through study completion, an average of 1 year
|
Time to transplant
Time Frame: through study completion, an average of 1 year
|
Time to transplant will be obtained from medical records
|
through study completion, an average of 1 year
|
Patient survival at 90 days
Time Frame: through study completion, an average of 1 year
|
Vital status will be obtained from medical records
|
through study completion, an average of 1 year
|
Ride-related data among intervention participants
Time Frame: through study completion, an average of 1 year
|
Number of rides, distance/commute time, cost
|
through study completion, an average of 1 year
|
Patient satisfaction with care
Time Frame: through study completion, an average of 1 year
|
Measured by patient satisfaction survey
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS-21-00576
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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