Clinical trial NCT03557086: A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
Official title: A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Liver Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Eligible Participants Enrolled in the Study
timeFrame: By 12 months
Secondary outcomes:
measure: Changes in Knowledge Scores From Baseline to Post-intervention
timeFrame: Baseline and post-intervention, by 12 months
measure: Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation
timeFrame: By 12 months
measure: Code Status Documentation
timeFrame: By 12 months
measure: Number of Participants Who Answered That They Felt "Very Comfortable" Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort)
timeFrame: By 12 months
measure: Number of Participants Who Answered That They Felt the Video Was "Very Helpful" in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful)
timeFrame: Within 12 months
measure: 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)
timeFrame: within 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.