A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease

Massachusetts General Hospital1 site in 1 country50 target enrollmentSeptember 28, 2018

ConditionsEnd Stage Liver Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: End Stage Liver Disease
Sponsor: Massachusetts General Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Number of Eligible Participants Enrolled in the Study
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (ACP) video decision support tool for improving patients' knowledge regarding their goals of care options and end of life (EOL) decision-making in patients with end-stage liver disease (ESLD).

Registry

clinicaltrials.gov

Start Date

September 28, 2018

End Date

March 3, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Nneka nnaoke Ufere

Assistant Professor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•≥ 18 years of age with an established diagnosis of end-stage liver disease
•Patient must have either 1) primary hepatologist at the MGH Liver Center or an MGH-affiliated primary care physician, or 2) a previous inpatient admission at MGH
•Deemed ineligible for liver transplantation as determined by the primary hepatologist
•Ability to communicate in English and provide informed consent
•A score ≥ 7 on the Short Portable Mental Status Questionnaire

Exclusion Criteria

•Severe hepatic encephalopathy which the primary hepatologist believes prohibits informed consent or participation in the study
•Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary hepatologist believes prohibits informed consent or participation in the study
•Prior history of liver transplantation
•Patient has been referred to or enrolled in hospice care
•Patients who have been referred to palliative care

Outcomes

Primary Outcomes

Number of Eligible Participants Enrolled in the Study

Time Frame: By 12 months

The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.

Secondary Outcomes

Code Status Documentation(By 12 months)
Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation(By 12 months)
Changes in Knowledge Scores From Baseline to Post-intervention(Baseline and post-intervention, by 12 months)
Number of Participants Who Answered That They Felt "Very Comfortable" Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort)(By 12 months)
Number of Participants Who Answered That They Felt the Video Was "Very Helpful" in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful)(Within 12 months)
Number of Participants Who Answered That They Would "Definitely Recommend" the Video to Other Patients in Response to Third Question on Acceptability Questionnaire (Acceptability - Recommend to Others)(within 12 months)