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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2020-03-03

Brief Summary

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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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Detailed Description

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Conditions

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End Stage Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Advance Care Planning Video Decision Support Tool

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Verbal Narrative

Intervention Type OTHER

Verbal description of end of life care options

Interventions

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Advance Care Planning Video Decision Support Tool

Advance care planning video intervention as previously described

Intervention Type BEHAVIORAL

Verbal Narrative

Verbal description of end of life care options

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No