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Uncertainty Management Intervention for Patients Awaiting Liver Transplant

Phase 3
21 Years
Open (Enrolling)
Liver Diseases

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Trial Information

Uncertainty Management Intervention for Patients Awaiting Liver Transplant

Hepatitis C Virus is the most common blood-borne infection in the U.S., affecting at least 4
million individuals, with more than 19,000 new cases occurring each year. Further, the CDC
has projected a fourfold increase in the number of chronic hepatitis C patients between 1990
and 2015, and these patients are at risk for developing end stage liver disease (ESLD). By
2015 an estimated 375,000 chronic hepatitis C patients will develop cirrhosis and progress
to ESLD, representing the majority of individuals who need liver transplants. ESLD is a
life-limiting illness, and patients are told that, without a liver transplant, they may die.

This 5 year randomized controlled trial will test the efficacy of an Uncertainty Management
Intervention delivered via telephone by a nurse to the patient and caregiver. An attention
control group of patients and caregivers will receive phone calls to discuss their
experience of awaiting a liver transplant. Based on the problems and concerns of patients
waiting for a liver transplant and the prior success of the Intervention for patients
dealing with serious chronic illness, we believe the Uncertainty Management Intervention
adapted specifically for ESLD patients will lead to significant improvements in patients'
and caregivers' abilities to manage the symptoms and distress associated with ESLD and the
process of awaiting liver transplant.

The specific aims are to: 1) examine the effects of the Uncertainty Management Intervention
on patient outcomes of psychological distress, uncertainty management, symptom control, self
efficacy for symptom management, and QOL compared to an attention control group receiving
calls to discuss their disease experience; 2) explore the effects of the Intervention on
caregiver outcomes of uncertainty management, self-efficacy for helping the patient manage
symptoms, and better QOL compared to an attention control group; 3) identify characteristics
of individuals for whom the intervention is particularly effective.

Waiting for a liver transplant under conditions of uncertainty is a harrowing experience for
patients and caregivers, yet there have been few attempts to test nursing interventions for
ESLD patients. The overall goal of this project is to provide these patients and their
caregivers the tools to self-manage their complex concerns. The anticipated outcome is ESLD
patients awaiting liver transplant benefit from the Uncertainty Management Intervention,
thus providing new knowledge for practitioners and policy makers.

Inclusion Criteria:

- Patients diagnosed with ESLD awaiting a liver transplant who are receiving care at
the Liver Clinic at Duke University and UNC-Chapel Hill Medical Centers and their

Exclusion Criteria:

- Under 21 years of age

- Cognitive Impairment

- Non-English speaking

- Patient does not have a caregiver willing to participate.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Uncertainty Management

Outcome Time Frame:

five months

Safety Issue:


Principal Investigator

James Tulsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University School of Nursing


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

July 2013

Related Keywords:

  • Liver Diseases
  • liver disease
  • uncertainty
  • self management
  • Liver Diseases



Duke UniversityDurham, North Carolina  27710
University of North Carolina-Chapel HillChapel Hill, North Carolina  27599