Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03878329 |
| Other study ID # |
TelehealthOLT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
University of Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A significant opportunity exists to involve patients and their caregivers in more effective
perioperative care and transition to home for transplant patients. Stakeholders were engaged
through the University of Cincinnati Liver Transplant Program to prioritize changes in
improving post transplant care. The initial findings indicated that increasing "care between
visits" is the top priority for patients for improving function, quality of life and
independence. Building on existing telehealth research, an enhanced home management program
(HMP) to leverage and improve patient self-care following liver transplantation was
developed, specifically by improving adherence, reducing readmissions and improving the
transition from hospital to home. 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.
With patient engagement, a randomized controlled trial is proposed comparing traditional
provider-based care vs. traditional care with HMP. These two arms will need 50 patients in
each arm with a 0.5 year follow up. Patients have said that the primary outcomes are quality
of life, function and independence. To that end, the primary study outcomes are assessment of
adherence, readmissions (90-day), patient satisfaction. 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.
Description:
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.
Aim 2: Evaluate the impact of the HMP on more distal clinical outcomes post liver
transplantation including weight control, diabetes management, blood pressure regulation and
depression.
Hypothesis: Enhanced home monitoring will have persisting health benefits beyond the 90-day
time frame of the HMP intervention on a variety of chronic disease measures important in this
population, including weight loss, diabetes management, blood pressure control, and
depression.
