Clinical trial NCT00938795: Uncertainty Management Intervention
Official title: Uncertainty Management Intervention for Patients Awaiting Liver Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: liver disease
uncertainty
self management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2009-07-14
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to improve symptoms and quality of life for end-stage liver disease patients awaiting a liver transplant and their caregivers by providing them with the resources and tools to self-manage their complex concerns.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (patient):

* Diagnosis of ESLD and on the liver transplant waiting list
* Receiving care at a Liver Clinic in the United States
* 18 years of age or older
* MELD greater than or equal to 11
* Able to read and speak English
* No major cognitive impairment
* Not a recipient of a prior transplant (any organ)
* Has a caregiver willing to participate

Inclusion Criteria (caregiver):

* 18 years of age or older
* Able to read and speak English
* Provides care to a patient meeting the above criteria

Primary outcomes:
measure: Uncertainty Management
timeFrame: Five months
Secondary outcomes:
measure: Symptom control
timeFrame: Five months
measure: Quality of life
timeFrame: Five months
measure: Psychological distress
timeFrame: Five months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The University of Nebraska Medical Center
state: Nebraska
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: The University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Duke University School of Nursing
name: James Tulsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University School of Nursing
name: Donald Bailey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Pittsburgh
name: Annette Devito Dabbs, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Paul H. Hayashi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Nebraska Medical Center
name: Laurel Williams-Salonen, RN,MSN,CCTC
role: PRINCIPAL_INVESTIGATOR
References: