Randomized Prospective Trial of Telemedicine Based Remote Home Monitoring After Liver Transplantation

The successful care of patients undergoing liver transplantation and support of their caregivers consumes significant personal, institutional and community resources before and after surgery. Depression and anxiety are common after transplant, leading to apprehension about the ability to care successfully for oneself and poor adherence with complex medication and health behavior regimens.1,2 Although a patient's quality of life improves immediately following transplantation, when compared with the general population the vast majority of liver transplant recipients have significant deficiencies in most quality of life domains.3,4 This is most evident in minorities and patients of low socioeconomic status who have difficulty adjusting to the demands of complex medical and surgical care and are challenged by lack of literacy and cultural bias.5-7 Indeed, the reoperation and readmission rate in the first 90 days are the highest of any surgery performed in the United States.8 Effective perioperative care is critical following surgery in this high acuity patient population. Optimizing care in the perioperative period should improve recovery and outcomes, including depression, general health maintenance and long-term adherence.9,10 While practice guidelines for care after liver transplant exist, they lack specifics and are based on outdated models that do not reflect patient preferences, needs or expectations. Improving current processes in health care delivery before and after liver transplantation is critical to optimize outcomes that matter: survival, function, and independence. The improvement of care may have profound effect in the first 90 days after transplant on important long-term health parameters that affect clinical outcomes such as depression, weight gain, blood pressure control and diabetes management.11 Through a stakeholder engagement process with the University of Cincinnati Liver Transplant Program designed to find ways to improve post transplant care, increasing "care between visits" is the top priority for patients to improve function, quality of life and independence. Patients said that medication adherence and hospital readmissions are their largest barrier to success, and that they believe care immediately post-transplant in the first 90 days is the most important determinant of long-term outcomes. A twenty-patient pilot program assessed the feasibility of a patient-designed telehealth monitoring program after liver transplant, and it met with an extraordinary level of enthusiasm by our patients. In this proposal, the ability of this home management program (HMP) will be tested, developed by patients for patients, to improve transition care from hospital to home and patient adherence with a self-care regimen following liver transplantation.

The medical community must develop innovative health delivery systems following complex surgeries like transplantation in order to maximize post-operative care, adherence to a new and complex self-care regimen, independence, and ultimately survival. Our proposed telehealth delivery model will optimize the quality, efficiency and outcomes of post-discharge care following liver transplantation. The HMP model will advise providers, health care systems, and transplant centers how to improve patient care, especially among those at greatest risk of poor outcomes, specifically minorities and those of low socioeconomic status. The objective of this proposal with the following specific aims:

Aim 1: Perform a randomized clinical trial to evaluate the impact of an enhanced, telehealth-based home management program (HMP) on medication and behavioral self-care adherence rates, and on 90-day and 1-year readmission rates following discharge for liver transplantation.

Hypothesis: Through enhanced patient engagement, HMP will increase medication and self-care adherence rates and reduce 90-day and 1-year readmission rates when compared to a traditional care model.

SubAim 1A: To determine whether underserved and minority patients achieve greater benefit from the HMP compared with more advantaged patient populations.