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

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.

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 data supports the effectiveness of the treatment Health Advocate, Health Advocate, Patient Navigator, Care Coordinator 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 recipients by facilitating their transfer from pediatric to adult services. Additionally, nurse practitioners, who often act as health advocates, play a crucial role in enhancing the quality of care for adolescent transplant recipients by addressing their unique developmental needs and promoting adherence to medical regimens. ^{1 2 3 4 5}

Is the Health Advocate program safe for adolescent liver transplant recipients?

The research articles provided do not contain specific safety data for the Health Advocate program or similar roles like Patient Navigator or Care Coordinator in adolescent liver transplant recipients. They focus on general patient safety and adverse event reporting, but not on the safety of these specific programs. ^{6 7 8 9 10}

How is the Health Advocate treatment different from other treatments for adolescent liver transplant recipients?

The Health Advocate treatment is unique because it focuses on providing personalized support and guidance to adolescent liver transplant recipients, helping them navigate their medical care and transition to adult services. This approach emphasizes teamwork between the patient's family and the healthcare team, addressing the specific developmental and psychosocial needs of adolescents, which is not typically the focus of standard medical treatments. ^{1 4 11 12 13}

Research Team

Sharad Wadhwani, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Health Advocate (Behavioral Intervention)

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

This is a single arm pilot intervention.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Working together as a team: adolescent transplant recipients and nurse practitioners. [2022]

2. United States 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. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Quality improvement in the care of live liver donors: implementation of the Designated Donor Nurse Program. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Allied health and nursing practices in pediatric solid organ transplantation: An international survey. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

OPTN/SRTR 2017 Annual Data Report: Liver. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. [2007]

7. England pubmed.ncbi.nlm.nih.gov

An audible patient voice: How can we ensure that patients are treated as partners in their own safety? [2021]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Adverse Event Reporting by Adolescent Patients and Their Families. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

National survey of adult transplant hepatologists on the pediatric-to-adult care transition after liver transplantation. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Transition of care to adult services for pediatric solid-organ transplant recipients. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Liver transplantation in children: update 2010. [2010]