Transportation Assistance Program for Liver Transplant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Transplantation

Intervention / Treatment
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* Other: Transportation assistance (Lyft rides)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transportation assistance, reports unreliable transportation<br>Lyft rides provided to transplant-related appointments | Other: Transportation assistance (Lyft rides)<br>* Lyft rides will be provided to patients for any transplant-related medical visits<br>|
| No Intervention: No transportation assistance, reports unreliable transportation<br>No intervention, standard-of-care | |
| No Intervention: Transportation assistance, control<br>No intervention, standard-of-care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion waitlisted/transplanted | Proportion waitlisted/transplanted will be obtained from medical records | through study completion, an average of 1 year | 
| Number of no-shows/cancellations | Number of no-shows/cancellations will be obtained from medical records | through study completion, an average of 1 year | 
| Number of hospitalizations | Number of hospitalizations will be obtained from medical records | through study completion, an average of 1 year | 
| Time to transplant | Time to transplant will be obtained from medical records | through study completion, an average of 1 year | 
| Patient survival at 90 days | Vital status will be obtained from medical records | through study completion, an average of 1 year | 
| Ride-related data among intervention participants | Number of rides, distance/commute time, cost | through study completion, an average of 1 year | 
| Patient satisfaction with care | Measured by patient satisfaction survey | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transportation, health services, intervention trial