Health Advocate Support for Liver Transplant Complications

(HEAL-Tx Pilot Trial)

Overseen By Sharad Wadhwani, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English, Non-US residents, 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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Health Advocate on the liver transplant team can benefit children who have undergone a liver transplant. The Health Advocate will coordinate medical care, provide financial assistance such as taxi vouchers, and connect families to community resources. The trial will assess the practicality and reception of this support among families. It is suitable for children under 18 who have had a liver transplant and whose families are willing to participate. As an unphased trial, it offers families the opportunity to access additional support and resources that could significantly ease their post-transplant journey.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this health advocate intervention is safe for pediatric liver transplant patients?

Research shows no specific safety data for the Health Advocate program. This role, similar to a Patient Navigator or Care Coordinator, assists children who have had liver transplants and their families. The program manages medical care, provides financial assistance, and connects families with community resources, enhancing communication with healthcare teams. Although direct safety data is lacking, the Health Advocate role does not involve medical procedures or medications, suggesting it is generally safe as it focuses on support rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of a Health Advocate to support patients dealing with liver transplant complications. Unlike standard treatments that focus on medications and surgical interventions, this approach introduces a personalized support system aimed at navigating the healthcare process and improving patient outcomes. The unique feature here is the emphasis on advocacy and personalized care, which could potentially enhance recovery and quality of life for transplant patients by addressing both medical and non-medical challenges. This trial hopes to find out if having a dedicated Health Advocate can make a significant difference in the overall treatment experience and success for liver transplant recipients.

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

Research has shown that a Health Advocate can benefit liver transplant patients. In this trial, participants will receive support from a Health Advocate, who organizes medical care and offers support, such as financial assistance, potentially improving health outcomes. For children who have undergone liver transplants, a Health Advocate is associated with better management of post-transplant needs. This role connects families with the healthcare system, facilitating communication and enhancing care effectiveness. Although further research is needed to confirm these findings, early indications suggest positive effects on patient care. ^{1 2 3 4 5}

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 children under 18 who have had a liver transplant. They and/or their guardians must understand English or Spanish, agree to the study's terms, and be chosen by the transplant team as suitable participants. It excludes adults, non-English/Spanish speakers, those unwilling to complete surveys, wards of the state, and non-US residents.

Inclusion Criteria

I am under 18 and have had a liver transplant.

Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures

Subject and/or parent/legal guardian is willing to be contacted in the future by study staff

Exclusion Criteria

Non-US residents

Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances

I do not speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Health Advocate intervention aimed at improving self-management and communication with the healthcare system

90 days

Regular interactions with Health Advocate

Follow-up

Participants are monitored for changes in caregiver experience and medication adherence

90 days

In-depth interviews and surveys

Extended Follow-up

Assessment of medication adherence 6 months after study entry

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Health Advocate

Trial Overview The HEAL-Tx Pilot tests if adding a Health Advocate to the pediatric liver transplant team helps with care coordination, financial support like taxi vouchers, and linking families to community resources. The goal is to see if this improves self-care and communication between families and healthcare providers.

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+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

The study followed 145 patients at Hadassah Medical Center before and after liver transplantation, providing insights into the medical and nursing care involved in the process.

The review highlights the importance of nursing coordinators in managing liver transplantation, addressing factors like liver disease causes, drug side effects, complications, and patient survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation and nursing care in Israel. Rowe, M., Safadi, R., Ashur, Y., et al.[2019]

The process of receiving a liver transplant involves a complex emotional journey for the patient, characterized by feelings of waiting, hope, fear, and survival.

Nurse-coordinators play a crucial role in supporting patients throughout this journey, helping them navigate the psychological challenges from diagnosis to the transplant procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A liver transplant, a specific temporal experience]. Sabar, I., Berthelot, G., Danet, C., et al.[2012]

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]

Nurses play a crucial role in the multidisciplinary care of liver transplant patients, particularly during critical phases of the transplant process, by being accountable for planning and evaluating patient care.

Effective communication by the transplant nurse is essential for coordinating care and supporting patients in achieving independence post-transplant through education on diet, medications, and monitoring health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the nurse in the multidisciplinary team approach to care of liver transplant patients. Overman, JA., Cox, DL., Buchl, LL., et al.[2019]

A study analyzing 17,868 medical adverse event records from Maccabi Healthcare Community found that communication issues and inattentiveness were the most frequently reported problems by both physicians and nurses.

The research suggests implementing better information-sharing and feedback mechanisms to reduce preventable medical adverse events, highlighting the need for targeted quality improvement efforts in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined SNA and LDA methods to understand adverse medical events. Zhu, L., Reychav, I., McHaney, R., et al.[2020]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

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]

Liver transplantation is a viable treatment for end-stage liver disease, but there is a significant gap between the number of people waiting for transplants (16,377) and the number actually performed (6,492 in 2007), highlighting the need for better access and planning for potential recipients.

Post-transplant care is crucial to prevent complications such as graft dysfunction and infections, and requires a multidisciplinary approach, including the involvement of critical care nurses, to ensure successful long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical care management of the liver transplant recipient. Rudow, DL., Goldstein, MJ.[2008]

Effective post-operative care is crucial for patients after liver transplantation, emphasizing the need for immediate support and monitoring to ensure successful recovery.

The role of the transplant coordinator is vital in providing education and long-term follow-up, which helps improve health outcomes and quality of life for liver transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care of patients following liver transplantation. Fullwood, D., Jones, F., Lau-Walker, M.[2016]

Liver transplantation is the only definitive treatment for end-stage liver disease, with about 15% of recipients in the U.S. being 65 or older, highlighting the importance of careful management in older patients.

Post-transplant complications such as infection and acute graft rejection can be minimized through strict adherence to follow-up care and medication management, emphasizing the critical role of nurses in educating patients and their support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver transplantation in older adults. Hansen, L.[2014]

The failure to report potential deceased organ donors and issues during the procurement process can lead to longer wait times and higher mortality rates for patients on transplant lists, highlighting a significant societal impact.

Nurses play a crucial role in the organ procurement process, as their education and experience enable them to help identify risks and implement strategies to prevent errors, ensuring better outcomes for potential transplant candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of nurses in the risk management of organ and tissue donation. Saviozzi, A.[2010]

Citations

1. 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 ...

2. withpower.com withpower.com/trial/phase-liver-transplant-complications-2023-a7a90

Health Advocate Support for Liver Transplant Complications What data supports the effectiveness of the treatment Health Advocate, Health Advocate, Patient Navigator, Care Coordinator for liver transplant complications?

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

HEalth Advocate for Liver Transplantation - UCSF Clinical Trials Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi ...

4. 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 ...

5. 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 ...