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

NCT03557086 | Completed Results DMC

• 1 other identifier: 2018P001146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

End Stage Liver Disease

Outcome Measures

Primary Outcomes (1)

• Number of Eligible Participants Enrolled in the Study

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

  By 12 months

Secondary Outcomes (6)

• Changes in Knowledge Scores From Baseline to Post-intervention

  Baseline and post-intervention, by 12 months

• Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation

  By 12 months

• Code Status Documentation

  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

Study Arms (2)

Advanced Care Planning Video Decision Support Tool

EXPERIMENTAL

We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.

Behavioral: Advance Care Planning Video Decision Support Tool

Verbal Narrative Control

ACTIVE COMPARATOR

Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant

Other: Verbal Narrative

Interventions

Advance Care Planning Video Decision Support Tool BEHAVIORAL

Advance care planning video intervention as previously described

Advanced Care Planning Video Decision Support Tool

Verbal Narrative OTHER

Verbal description of end of life care options

Verbal Narrative Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Ufere NN, Robinson B, Donlan J, Indriolo T, Bloom J, Scherrer A, Mason NM, Patel A, Lai JC, Chung RT, Volandes A, El-Jawahri A. Pilot Randomized Controlled Trial of an Advance Care Planning Video Decision Tool for Patients With Advanced Liver Disease. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2287-2295.e3. doi: 10.1016/j.cgh.2021.10.027. Epub 2021 Oct 27.

  PMID: 34718173 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Nneka Ufere
• Organization: Massachusetts General Hospital

nneka.ufere@mgh.harvard.edu

617-643-3408

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: September 28, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: March 18, 2024
• Results First Posted: November 3, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)