Trial Outcomes & Findings for A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease (NCT NCT03557086)
NCT ID: NCT03557086
Last Updated: 2024-03-18
Results Overview
The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.
COMPLETED
NA
50 participants
By 12 months
2024-03-18
Participant Flow
Participant milestones
| Measure |
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.
Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described
|
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
Baseline characteristics by cohort
| Measure |
Advanced Care Planning Video Decision Support Tool
n=26 Participants
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.
Advance Care Planning Video Decision Support Tool: Advance care planning video intervention as previously described
|
Verbal Narrative Control
n=24 Participants
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
Verbal Narrative: Verbal description of end of life care options
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
58.5 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
Some high school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
High school graduate
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Education
Some college
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
College graduate
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Postgraduate
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Married or with a partner
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital Status
Single
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Model for End-Stage Liver Disease-Sodium (MELD-Na) Score
|
16 units on a scale
n=5 Participants
|
16.5 units on a scale
n=7 Participants
|
16.5 units on a scale
n=5 Participants
|
|
Etiology of Liver Disease
Alcohol
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Etiology of Liver Disease
NASH/Cryptogenic
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Etiology of Liver Disease
Multifactorial/Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: By 12 monthsThe proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=59 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Number of Eligible Participants Enrolled in the Study
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, by 12 monthsWe 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.
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=26 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
Verbal Narrative Control
n=24 Participants
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Changes in Knowledge Scores From Baseline to Post-intervention
|
5.7 score on a scale
Standard Deviation 0.45
|
4.8 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: By 12 monthsBefore 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.
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=26 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
Verbal Narrative Control
n=24 Participants
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation
Post-intervention preferences for life-prolonging care
|
4 Participants
|
7 Participants
|
|
Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation
Post-intervention preferences to receive CPR
|
9 Participants
|
15 Participants
|
|
Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation
Post-intervention preferences to receive intubation
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: By 12 monthsPopulation: Data not collected due to lack of access to outside hospital electronic medical records to confirm code status documentation
Code status documentation in the electronic health record will be compared between the intervention and control arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: By 12 monthsPopulation: Patients randomized to the Advanced Care Planning Video Decision Support Tool intervention arm
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".
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=26 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Number of Participants Who Answered That They Felt "Very Comfortable" Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort)
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 12 monthsFor 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".
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=26 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
Number of Participants Who Answered That They Felt the Video Was "Very Helpful" in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful)
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: within 12 monthsFor 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".
Outcome measures
| Measure |
Patients Approached for Enrollment Into the Study
n=26 Participants
We pre-specified the ACP video intervention as feasible if at least 60% of eligible patients enrolled in the study.
|
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
Verbal Narrative: Verbal description of end of life care options
|
|---|---|---|
|
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 Participants
|
—
|
Adverse Events
Advanced Care Planning Video Decision Support Tool
Verbal Narrative Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place