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

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).

Study Overview

• Status: Completed
• Conditions: End Stage Liver Disease
• Intervention / Treatment: Behavioral: Advance Care Planning Video Decision Support Tool; Other: Verbal Narrative

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥ 18 years of age with an established diagnosis of end-stage liver disease
2. 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
3. Deemed ineligible for liver transplantation as determined by the primary hepatologist
4. Ability to communicate in English and provide informed consent
5. A score ≥ 7 on the Short Portable Mental Status Questionnaire

Exclusion Criteria:

1. Severe hepatic encephalopathy which the primary hepatologist believes prohibits informed consent or participation in the study
2. 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
3. Prior history of liver transplantation
4. Patient has been referred to or enrolled in hospice care
5. Patients who have been referred to palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Care Planning Video Decision Support Tool; 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; Advance care planning video intervention as previously described
Active Comparator: Verbal Narrative Control; 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; Verbal description of end of life care options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Knowledge Scores From Baseline to Post-intervention	We will assess patients' knowledge of goals of care before and after the intervention using 5 true/false questions and 1 multiple choice question, each worth 1 point, for a summary score of 0 to 6 (higher score reflects greater knowledge). We have used this knowledge questionnaire in prior studies. Changes in knowledge scores from before and after the intervention will be compared between the intervention and control arms.	Baseline and post-intervention, by 12 months
Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation	Before and after the intervention, patients will report their post-intervention preferences for life-prolonging care: life-prolonging care, limited medical care, comfort care, or unsure. Before the intervention, patients will report their preferences to receive CPR as follows: "Yes, attempt CPR", "No, do not attempt CPR", or "Not sure." Before the intervention, patients will report their preferences to receive intubation as follows: "Yes, attempt intubation", "No, do not attempt intubation", or "Not sure." Post-intervention preferences for life-prolonging care (life-prolonging care, limited medical care, and comfort care), preferences to receive CPR, and preferences to receive intubation will be compared between the two groups.	By 12 months
Code Status Documentation	Code status documentation in the electronic health record will be compared between the intervention and control arms.	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)	For the video intervention arm alone, we will administer 3-items assessing patients' comfort with watching the video, whether they find the video helpful in their understanding of the EOL care options, and whether they would recommend it to others. For the outcome of "comfort" we asked patients whether they felt comfortable watching the video by asking the question: "Did you feel comfortable seeing the video in order to help you answer the questions regarding medical care?". Response choices were on a Likert scale with answer choices as follows: 1) very comfortable; 2) somewhat comfortable; 3) not comfortable; 4) don't know. We report below the percentage of patients who answered "very comfortable".	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)	For the video intervention arm alone, we will administer 3-items assessing patients' comfort with watching the video, whether they find the video helpful in their understanding of the EOL care options, and whether they would recommend it to others. For the outcome of "helpful" we asked patients whether they felt the video was helpful by asking the question: "Was the video helpful in improving your understanding about your choices for medical care?". Response choices were on a Likert scale with answer choices as follows: 1) very helpful; 2) somewhat helpful; 3) a little helpful; 4) not helpful. We report below the percentage of patients who answered "very 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)	For the video intervention arm alone, we will administer 3-items assessing patients' comfort with watching the video, whether they find the video helpful in their understanding of the EOL care options, and whether they would recommend it to others. For the outcome of "recommend to others" we asked patients whether they would recommend the video to other patients by asking the question: "Would you recommend the video to other patients with advanced liver disease who are facing a similar decision?". Response choices were on a Likert scale with answer choices as follows: 1) I would definitely recommend it; 2) I would probably recommend it; 3) I would probably not recommend it; 4) I would definitely not recommend it. We report below the percentage of patients who answered "I would definitely recommend it".	within 12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: 2018P001146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No