Health Advocate for Adolescent Liver Transplant Recipients

(HEAL-Tx:ToC Trial)

Recruiting at 1 trial location

Overseen By Sharad Wadhwani, MD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, Age, Ward of state, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support system to assist young people transitioning from pediatric to adult care after a liver transplant. The focus is on using a Health Advocate (also known as a Patient Navigator or Care Coordinator) to coordinate medical appointments, connect patients to community resources, and provide practical support. The trial seeks participants who received a liver transplant over a year ago and will soon switch to adult care, especially those facing challenges like food insecurity. As an unphased trial, this study offers a unique opportunity to improve the transition process and receive personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this health advocate intervention is safe for adolescent liver transplant recipients?

Research has shown that teenagers who have had liver transplants generally do very well, with over 80% living more than 10 years. The Health Advocate program lacks specific safety data. This program supports young liver transplant patients by helping them manage their care, address financial issues, and find community resources. As it is not a medication, there are no drug-like side effects. The main goal is to enhance communication and support, not to provide medical treatment, which typically results in very few safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Advocate approach for adolescent liver transplant recipients because it offers personalized support that isn't a part of standard medical treatments. Unlike current options that focus mainly on medication and surgery, this approach involves a dedicated health advocate who helps young patients navigate the complexities of post-transplant life. The advocate provides tailored guidance, improves communication between patients and healthcare providers, and supports adherence to medical regimens. This method aims to enhance overall outcomes by addressing the unique emotional and social challenges faced by adolescents, offering a more holistic approach to care.

What evidence suggests that the Health Advocate intervention is effective for adolescent liver transplant recipients?

Studies have shown that a health advocate, similar to a transition coordinator, can assist pediatric liver transplant patients. This advocate organizes medical care, provides financial help, and connects patients to community resources. These efforts enhance how families manage care and communicate with healthcare teams. In this trial, participants will receive support from a health advocate. Although the health advocate role appears promising, more research is needed to confirm its effectiveness in improving post-transplant outcomes. Early findings suggest it could benefit adolescent liver transplant recipients by meeting social needs and improving care transitions. ^{1 3 4 6 7}

Who Is on the Research Team?

Sharad Wadhwani, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults who have had a liver transplant and are transitioning their care to adult transplant teams. It's designed to see if having a Health Advocate helps with this process.

Inclusion Criteria

Patient has a working phone and smart device capable of video and/or audio virtual visits via Zoom

Patient has an unmet social risk (e.g., food insecurity) or MLVI >/= 2.0

Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program

Exclusion Criteria

I do not speak English or Spanish.

Patient has significant cognitive impairment

Patient is a ward of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Integration of a Health Advocate onto the transplant team to assist adolescents in transitioning their care to adult transplant teams

180 days

Regular interactions with Health Advocate

Follow-up

Participants are monitored for changes in patient experience and medication adherence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Advocate

Trial Overview The HEAL-Tx pilot tests the integration of a Health Advocate into the transplant team. This role includes coordinating treatment, helping with finances like taxi vouchers, and linking patients to community resources.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This is a single arm pilot intervention.

Health Advocate is already approved in United States for the following indications:

Approved in United States as Health Advocate for:

• Pediatric liver transplant support
• Social risk mitigation
• Self-management improvement

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

American Society of Transplantation

Collaborator

Trials

2

Recruited

40+

Published Research Related to This Trial

A national survey of adult transplant hepatologists revealed that only 46.1% of young adult liver transplant recipients arrive at their first adult clinic with adequate knowledge of their condition and a parent or guardian, highlighting a significant gap in patient preparedness for transition.

Only 15.5% of hepatologists reported having a formal transition program, and those with such programs were less likely to see patient knowledge and adherence as barriers, suggesting that implementing structured transition strategies could enhance care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National survey of adult transplant hepatologists on the pediatric-to-adult care transition after liver transplantation. Heldman, MR., Sohn, MW., Gordon, EJ., et al.[2015]

Adverse events occurred in 1% of pediatric hospitalizations, with 0.6% being preventable, indicating that a significant number of children experience harm due to medical management rather than their underlying conditions.

The most common types of preventable adverse events were birth-related (32.2%) and diagnostic-related (30.4%), highlighting the need for targeted research and interventions in these areas to improve patient safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. Woods, D., Thomas, E., Holl, J., et al.[2007]

The use of a transition coordinator for pediatric liver transplant recipients led to significantly better medication adherence, as indicated by more stable tacrolimus blood levels compared to a historical comparison group, with a notable decrease in variability (SD) after transfer.

Psychosocial outcomes remained stable and the acceptability of the transition coordinator's role was high, suggesting that this approach may enhance the overall transition experience for young patients post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strangers headed to a strange land? A pilot study of using a transition coordinator to improve transfer from pediatric to adult services. Annunziato, RA., Baisley, MC., Arrato, N., et al.[2013]

In 2017, there was a significant increase in adult liver transplants in the US, with 8,082 transplants performed and a transplant rate of 51.5 per 100 waitlist-years, despite changing patient demographics such as older age and higher obesity rates.

Children listed for liver transplants were generally younger and sicker than in previous years, yet their survival rates post-transplant have improved, indicating advancements in surgical techniques and post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OPTN/SRTR 2017 Annual Data Report: Liver. Kim, WR., Lake, JR., Smith, JM., et al.[2023]

Nurse practitioners play a vital role in the transplant team by providing tailored care for adolescent transplant recipients, addressing their unique developmental needs to improve quality of life and adherence to medical regimens.

Effective teamwork involving the patient's family and the transplant team is essential for optimizing health outcomes and ensuring a smooth transition to adult care, particularly given the complex psychosocial challenges faced by adolescents post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working together as a team: adolescent transplant recipients and nurse practitioners. Lerret, SM., Stendahl, G.[2022]

A quality improvement project at an academic medical center aimed to enhance the inpatient experience for living liver donors by developing nursing standards and procedures for consistent care during their hospital stay.

The introduction of Designated Donor Nurses, who act as advocates and resources for live liver donors, is proposed to ensure specialized care and support, addressing the challenge of having all nursing staff be experts in donor care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement in the care of live liver donors: implementation of the Designated Donor Nurse Program. LaPointe Rudow, D., Cabello, CC., Rivellini, D.[2022]

A survey of 119 Allied Health and Nursing professionals in pediatric solid organ transplantation revealed that while many have extensive experience, funding for their roles is often lacking, particularly among allied health providers.

Resource constraints were identified as a significant barrier to practice, emphasizing the need for more support and the development of clinical practice guidelines to enhance the effectiveness of AHNP roles in pediatric transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allied health and nursing practices in pediatric solid organ transplantation: An international survey. Gold, A., Wray, J., Kosmach-Park, B., et al.[2023]

Adolescent patients and parents identified that their willingness to report adverse events in a pediatric hospital is influenced by their overall experience with the healthcare system, the quality of communication with providers, and their confidence in communicating effectively.

Participants expressed a desire for a user-friendly reporting system that ensures confidentiality and provides feedback, with preferred methods including face-to-face meetings, websites, smartphone apps, phone calls, and paper mail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Adverse Event Reporting by Adolescent Patients and Their Families. Sawhney, PN., Davis, LS., Daraiseh, NM., et al.[2021]

Effective transition to adult health care is crucial for young solid-organ transplant recipients, impacting both immediate graft survival and long-term health outcomes.

The article provides recommendations for health care professionals to improve communication, motivation, and adherence during the transition process, addressing the unique challenges faced by adolescents and young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition of care to adult services for pediatric solid-organ transplant recipients. Bell, LE., Sawyer, SM.[2022]

Pediatric liver transplant recipients are increasingly surviving longer, which raises new concerns about the long-term effects of immunosuppressive therapy, including complications and the potential for withdrawal of these medications.

Effective care for these patients requires ongoing collaboration among a wide range of healthcare professionals, including pediatricians, transplant specialists, and support staff, to address issues like quality of life and the shortage of donor organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation in children: update 2010. Kamath, BM., Olthoff, KM.[2010]

Patients and their families often have concerns that can precede serious adverse events in healthcare, highlighting the importance of their input in clinical settings.

Empowering patients to actively participate in documenting their clinical history could lead to safer healthcare systems by ensuring their concerns are acknowledged and addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An audible patient voice: How can we ensure that patients are treated as partners in their own safety? Subbe, CP., Ahsan, S., Smith, L., et al.[2021]

The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to allow children aged 7-15 with cancer to self-report adverse events, showing good understanding and ability to provide valid responses during cognitive interviews with 81 participants.

The study confirmed the content validity of the PRO-CTCAE, with revisions made to 15 adverse event terms based on feedback, indicating that this tool can enhance the accuracy of adverse event reporting in pediatric oncology trials and improve the quality of care for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative. Reeve, BB., McFatrich, M., Pinheiro, LC., et al.[2022]

Baylor Medical Center at Grapevine has transitioned from paper-based reporting to an online system for documenting adverse events and close calls, enhancing patient safety protocols.

This shift to digital reporting allows for more efficient tracking and management of patient safety incidents, indicating a significant improvement in the hospital's approach to ensuring patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a stronger patient safety program using the Internet takes step-by-step planning. Atherton, T.[2004]

Citations

1. withpower.com withpower.com/trial/phase-all-pediatric-2-2024-fe3c0

Health Advocate for Adolescent Liver Transplant Recipients The use of a transition coordinator, similar to a patient navigator or care coordinator, has been shown to improve outcomes for pediatric liver transplant ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40833298/

Coproducing a health advocate intervention for pediatric ... Future studies should test the effectiveness of this navigator role in improving posttransplant outcomes. Keywords: double-diamond model ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06386198

HEalth Advocate for Liver Transplantation - UCSF Clinical Trials In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1600613524000984

Patient-centered research in pediatric transplant: Engaging ... Our aim was to build capacity for PCOR among pediatric LT providers and recipient families, by implementing a transplant-focused curriculum for both groups.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05700799

NCT05700799 | HEalth Advocate for Liver Transplant - Pilot The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food ...

6. reporter.nih.gov reporter.nih.gov/project-details/9638280

Improving Medication Adherence in adolescents who had ... At-risk adolescent liver transplant recipients (MLVI>2) will be enrolled in a randomized controlled trial across several transplant centers. In the active ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0168827811007203

The adolescent and liver transplantation Adolescents with liver transplants have excellent survival rates, over 80% of them surviving more than 10 years.