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OpenTrials
Completed

NCT Number: NCT05080595

Transportation Assistance Program for Liver Transplant

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Transplant Clinic

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transportation assistance (Lyft rides)

Other

Lyft rides will be provided to patients for any transplant-related medical visits

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Proportion waitlisted/transplanted

    Time frame: through study completion, an average of 1 year

    Proportion waitlisted/transplanted will be obtained from medical records

  3. 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

  4. Number of hospitalizations

    Time frame: through study completion, an average of 1 year

    Number of hospitalizations will be obtained from medical records

  5. Time to transplant

    Time frame: through study completion, an average of 1 year

    Time to transplant will be obtained from medical records

  6. Patient survival at 90 days

    Time frame: through study completion, an average of 1 year

    Vital status will be obtained from medical records

  7. Ride-related data among intervention participants

    Time frame: through study completion, an average of 1 year

    Number of rides, distance/commute time, cost

  8. Patient satisfaction with care

    Time frame: through study completion, an average of 1 year

    Measured by patient satisfaction survey

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Pilot Randomized Controlled Trial of a Need-Based Transportation Assistance Program in Liver Transplant Candidates

Acronym: TAP-LT

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 18, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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