Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant (TEST)

University of Pennsylvania

Status: Enrolling

Conditions: Liver Transplant; Complications; Medication Adherence; Cirrhosis; End Stage Liver DIsease

Treatments: Behavioral: TEST Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05260268

849575

Details and patient eligibility

About

Liver transplantation is increasingly performed for older adults with multiple comorbidities. Medication adherence is key to maintaining proper function of the transplanted liver and optimize health; however, adhering to post-transplant treatment is complex. This trial will study how available technology combined with transplant center resources and caregiver support can optimize medication adherence, quality of life, and health outcomes among new liver transplant recipients at 3 centers.

Full description

Liver transplant, the only cure for end-stage liver disease, is a costly and limited resource that increases survival. It is increasingly performed among older adults who have a higher burden of comorbidities, medical complexity, and are at risk of non-adherence. In addition, liver transplant recipients must manage complex immunosuppression regimens to maintain graft function. Inadequate immunosuppression adherence is common post-liver transplant and has many adverse consequences including liver graft rejection, graft failure, and re-transplantation. To maintain their health, liver transplant recipients must also self-manage regimens for multiple chronic conditions beyond liver transplant.

The TEST Trial intervention is a conceptual framework to address health system and patient level barriers to adherence. By following the Cumulative Complexity Model and the Multiple Chronic Conditions Model, this study focuses on liver transplant recipients and their involved caregivers. The TEST trial leverages the use of electronic health record and Way to Health (W2H) text message system to improve medication adherence.

TEST is a 2-arm, patient-randomized controlled trial at three large, diverse transplant centers: University of Pennsylvania (UPENN), Northwestern University (NU); University of Miami (UM). A total of 360 de novo LTRs age 50 or older (n=180 per arm) within 3 months of transplant will be recruited and randomized to intervention versus usual care for 18 months. Interviews will be conducted at baseline, 6, 12, and 18 months. The TEST intervention includes:

• Monthly W2H Adherence Assessment & Clinician Alerts
• Medication Reminders
• Laboratory and Appointment Notifications
• Supplemental Self-Management Support

The primary objective of the study is to investigate the effectiveness of the TEST Trial to improve adherence to immunosuppressant and non-immunosuppressant medication regimens, functional health status, and health outcomes compared to usual care. Secondary objectives will measure study fidelity and cost effectiveness.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Liver Transplant Recipient Inclusion Criteria:

• 18 years or older
• Within 3 months of liver transplant
• English or Spanish-speaking
• Home-dwelling*
• Patient or care partner owns a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.
• *The definition of "home" includes hotel or short-term housing. Patients who are going to a rehabilitation or skilled nursing facility (SNF) immediately after transplant may still be recruited if the site-PI/Co-I determines they are likely to be discharged to home within 3 months post-transplant.

Care Partner Inclusion Criteria:

• 18 years or older
• English or Spanish speaking
• Care partner has access to a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.

Liver Transplant Recipient Exclusion Criteria:

• Liver transplant recipient who speaks neither English nor Spanish
• Any severe uncorrectable vision, hearing, or cognitive impairments that may impede study interviews

Care Partner Exclusion Criteria:

• Care partner who speaks neither English nor Spanish

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual care refers to the normal standard clinical practices immediately post-transplant to the 18 months following. Liver Transplant Recipients at sites have lab values taken weekly for the first 8-10 weeks post-transplant, shifting to every 2-4 weeks for the next 3-4 months, then monthly to every 3 months thereafter depending on clinical needs. All sites follow a similar schedule of tapering clinic visits ranging from weekly in the first 4 weeks to every 2-4 weeks in months 4-6, every 3-6 months in months 7 12, and every 6 months in months 12-24. All sites assign each patient to a specific transplant coordinator, first paired with a transplant surgeon (first 3-6 months), and then a transplant hepatologist for the remainder of follow-up. All patients and caregivers receive standard medication teaching prior to hospital discharge and then ad hoc. No routine text message reminders, caregiver reminders, or adherence alerts are used in usual care.

TEST Intervention

Experimental group

Description:

Clinical activities for Usual Care will also be provided in the TEST arm. The TEST intervention is a technology-enabled strategy to routinely monitor regimen use, adherence, and persistence via a 'low touch', easy to use, online behavioral toolkit - Way to Health . It was developed by University of Pennsylvania researchers to automate behavioral intervention. The TEST approach includes monthly adherence assessments, with tailored adherence support. The following components will be included in the intervention: * Monthly W2H Adherence Assessment \& Clinician Alerts * Medication Reminders * Laboratory and Appointment Notifications * Supplemental Self-Management Support

Treatment:

Behavioral: TEST Intervention