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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Care Planning Video Decision Support Tool | Experimental | 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. |
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| Verbal Narrative Control | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Care Planning Video Decision Support Tool | Behavioral | Advance care planning video intervention as previously described |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34718173 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2020 |
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| Verbal Narrative | Other | Verbal description of end of life care options |
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| Baseline and post-intervention, by 12 months |
| 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 |
| Code Status Documentation | Code status documentation in the electronic health record will be compared between the intervention and control arms. | By 12 months |
| 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 |
| 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 |
| 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 |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Model for End-Stage Liver Disease-Sodium (MELD-Na) Score | Model for End-Stage Liver Disease-Sodium (MELD-Na) Score is used to estimate relative liver disease severity. Scores range from 6 (minimum) to 40 (maximum) with higher scores associated with increasing severity of hepatic dysfunction and increased three-month mortality risk. The total score (and total score ranges) are reported. | Median | Inter-Quartile Range | units on a scale |
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| Etiology of Liver Disease | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | By 12 months |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post-intervention, by 12 months |
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| 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. | Posted | Count of Participants | Participants | By 12 months |
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| Secondary | Code Status Documentation | Code status documentation in the electronic health record will be compared between the intervention and control arms. | Data not collected due to lack of access to outside hospital electronic medical records to confirm code status documentation | Posted | By 12 months |
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| 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". | Patients randomized to the Advanced Care Planning Video Decision Support Tool intervention arm | Posted | Count of Participants | Participants | By 12 months |
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| 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". | Posted | Count of Participants | Participants | Within 12 months |
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| 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". | Posted | Count of Participants | Participants | within 12 months |
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12 months
This study was a minimal risk study involving a video intervention tool. The only adverse event that was monitored for was serious distress by patients watching the video.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nneka Ufere | Massachusetts General Hospital | 617-643-3408 | nneka.ufere@mgh.harvard.edu |
| Aug 31, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| High school graduate |
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| Some college |
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| College graduate |
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| Postgraduate |
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| Missing |
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| Widowed |
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| Divorced |
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| Single |
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| NASH/Cryptogenic |
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| Multifactorial/Other |
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| OG001 | 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 |
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| OG001 | 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 |
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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
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