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A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557086
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
End Stage Liver Disease Behavioral: Advance Care Planning Video Decision Support Tool Other: Verbal Narrative Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : March 3, 2020
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: 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.
Behavioral: Advance Care Planning Video Decision Support Tool
Advance care planning video intervention as previously described

Active Comparator: 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
Other: Verbal Narrative
Verbal description of end of life care options




Primary Outcome Measures :
  1. Feasibility [ Time Frame: By 12 months ]
    The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.


Secondary Outcome Measures :
  1. Changes in knowledge scores [ Time Frame: 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.

  2. End of Life care, cardiopulmonary resuscitation, and intubation preferences [ Time Frame: By 12 months ]

    Before and after the intervention, patients will report their EOL care preferences as follows: life-prolonging care, limited medical care, comfort care, or unsure. Before the intervention, patients will report their CPR preferences as follows: "Yes, attempt CPR", "No, do not attempt CPR", or "Not sure." Before the intervention, patients will report their intubation preferences as follows: "Yes, attempt intubation", "No, do not attempt intubation", or "Not sure."

    Post-intervention end of life care preferences (life-prolonging care, limited medical care, and comfort care), CPR preferences, and intubation preferences will be compared between the two groups.


  3. Code status documentation [ Time Frame: By 12 months ]
    Code status documentation in the electronic health record will be compared between the intervention and control arms.

  4. Acceptability of the video intervention [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557086


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Raymond Chung, Director of Hepatology, Gastrointestinal Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03557086    
Other Study ID Numbers: 2018P001146
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency