A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
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|ClinicalTrials.gov Identifier: NCT03557086|
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|End Stage Liver Disease||Behavioral: Advance Care Planning Video Decision Support Tool Other: Verbal Narrative||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|