Transportation Assistance Program for Liver Transplant

Liver Transplantation Clinical Trial

— TAP-LT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05080595
• Other study ID #: HS-21-00576
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Other:
• Transportation assistance (Lyft rides)
Lyft rides will be provided to patients for any transplant-related medical visits

Locations

Country	Name	City	State
United States	Keck Transplant Clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to waitlisting for liver transplant	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	Proportion with reported transportation barriers	Number of patients who report transportation barriers vs those who don't will be obtained from our transportation barriers survey	1 year
Secondary	Proportion waitlisted/transplanted	Proportion waitlisted/transplanted will be obtained from medical records	through study completion, an average of 1 year
Secondary	Number of no-shows/cancellations	Number of no-shows/cancellations will be obtained from medical records	through study completion, an average of 1 year
Secondary	Number of hospitalizations	Number of hospitalizations will be obtained from medical records	through study completion, an average of 1 year
Secondary	Time to transplant	Time to transplant will be obtained from medical records	through study completion, an average of 1 year
Secondary	Patient survival at 90 days	Vital status will be obtained from medical records	through study completion, an average of 1 year
Secondary	Ride-related data among intervention participants	Number of rides, distance/commute time, cost	through study completion, an average of 1 year
Secondary	Patient satisfaction with care	Measured by patient satisfaction survey	through study completion, an average of 1 year