End Stage Liver Disease
Conditions
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).
Interventions
BEHAVIORALAdvance Care Planning Video Decision Support Tool
Advance care planning video intervention as previously described
OTHERVerbal Narrative
Verbal description of end of life care options
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Participants Enrolled in the Study | By 12 months | The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | By 12 months | 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. |
| Code Status Documentation | By 12 months | Code status documentation in the electronic health record will be compared between the intervention and control arms. |
| Changes in Knowledge Scores From Baseline to Post-intervention | Baseline and post-intervention, by 12 months | 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. |
| Number of Participants Who Answered That They Felt the Video Was Very Helpful in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful) | Within 12 months | 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. |
| 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) | within 12 months | 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. |
| Number of Participants Who Answered That They Felt Very Comfortable Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort) | By 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Advanced Care Planning Video Decision Support Tool | Verbal Narrative Control | Total |
|---|---|---|---|
| Age, Continuous | 60.5 years | 58.5 years | 60 years |
| Education College graduate | 9 Participants | 5 Participants | 14 Participants |
| Education High school graduate | 9 Participants | 10 Participants | 19 Participants |
| Education Missing | 1 Participants | 0 Participants | 1 Participants |
| Education Postgraduate | 2 Participants | 3 Participants | 5 Participants |
| Education Some college | 4 Participants | 6 Participants | 10 Participants |
| Education Some high school | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Liver Disease Alcohol | 15 Participants | 17 Participants | 32 Participants |
| Etiology of Liver Disease Multifactorial/Other | 5 Participants | 3 Participants | 8 Participants |
| Etiology of Liver Disease NASH/Cryptogenic | 6 Participants | 4 Participants | 10 Participants |
| Marital Status Divorced | 4 Participants | 6 Participants | 10 Participants |
| Marital Status Married or with a partner | 17 Participants | 14 Participants | 31 Participants |
| Marital Status Single | 3 Participants | 3 Participants | 6 Participants |
| Marital Status Widowed | 2 Participants | 1 Participants | 3 Participants |
| Model for End-Stage Liver Disease-Sodium (MELD-Na) Score | 16 units on a scale | 16.5 units on a scale | 16.5 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
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.
Time frame: By 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Approached for Enrollment Into the Study | Number of Eligible Participants Enrolled in the Study | 50 Participants |
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.
Time frame: Baseline and post-intervention, by 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Approached for Enrollment Into the Study | Changes in Knowledge Scores From Baseline to Post-intervention | 5.7 score on a scale | Standard Deviation 0.45 |
| Verbal Narrative Control | Changes in Knowledge Scores From Baseline to Post-intervention | 4.8 score on a scale | Standard Deviation 0.76 |
Secondary
Code Status Documentation
Code status documentation in the electronic health record will be compared between the intervention and control arms.
Time frame: By 12 months
Population: Data not collected due to lack of access to outside hospital electronic medical records to confirm code status documentation
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.
Time frame: Within 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Approached for Enrollment Into the Study | 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
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.
Time frame: By 12 months
Population: Patients randomized to the Advanced Care Planning Video Decision Support Tool intervention arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Approached for Enrollment Into the Study | 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
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.
Time frame: within 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Approached for Enrollment Into the Study | 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 |
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.
Time frame: By 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Approached for Enrollment Into the Study | 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 |
| Patients Approached for Enrollment Into the Study | Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | Post-intervention preferences to receive CPR | 9 Participants |
| Patients Approached for Enrollment Into the Study | Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | Post-intervention preferences to receive intubation | 6 Participants |
| Verbal Narrative Control | Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | Post-intervention preferences to receive CPR | 15 Participants |
| Verbal Narrative Control | Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | Post-intervention preferences to receive intubation | 8 Participants |
| Verbal Narrative Control | Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation | Post-intervention preferences for life-prolonging care | 7 Participants |