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

End Stage Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557086
• Other study ID #: 2018P001146
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

Behavioral:
• Advance Care Planning Video Decision Support Tool
Advance care planning video intervention as previously described

Other:
• Verbal Narrative
Verbal description of end of life care options

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Code Status Documentation	Code status documentation in the electronic health record will be compared between the intervention and control arms.	By 12 months
Secondary	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
Secondary	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
Secondary	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