N/A
N=50
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
End Stage Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT03557086 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Eligible Participants Enrolled in the Study — 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Advance Care Planning Video Decision Support Tool (Behavioral); Verbal Narrative (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eligible Participants Enrolled in the Study |
50 | — |
| SECONDARY Changes in Knowledge Scores From Baseline to Post-intervention |
5.7; 4.8 | — |
| SECONDARY Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation |
4; 7; 9; 15; 6; 8 | — |
| SECONDARY Code Status Documentation |
— | — |
| SECONDARY Number of Participants Who Answered That They Felt "Very Comfortable" Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort) |
21 | — |
| SECONDARY Number of Participants Who Answered That They Felt the Video Was "Very Helpful" in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful) |
19 | — |
| 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) |
24 | — |
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
- ≥ 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
Data sourced from ClinicalTrials.gov (NCT03557086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.