A ProspectiveTrial Using Video Images in Advance Care Planning in Hospitalized Seriously Ill Patients With Advanced Cancer
NCT ID: NCT01527331
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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1. a video visually depicting CPR preferences or
2. the current standard of care without the use of video (control).
Hypothesis 1: It is feasible to recruit and randomize 150 hospitalized subjects with advanced cancer and an overall prognosis of one year or less.
Aim 2: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.
Aim 3: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.
Hypothesis 3: Subjects randomized to the video are more likely to have their code status documented in the electronic medical records compared to those who do not see the video.
Aim 4: To compare the decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 4: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.
Aim 5: To compare knowledge assessment of CPR of subjects randomized to video and subjects randomized to current standard of care without the video.
Hypothesis 5: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.
Aim 6: To compare code-status (CPR, and intubation) preferences in the electronic medical record on future hospitalizations up to one year post-hospital discharge of subjects randomized to video and subjects randomized to current standard of care without the video.
Hypothesis 6: Subjects randomized to the video are more likely to opt against CPR and intubation in the future compared to those who do not see the video.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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control group
usual care
No interventions assigned to this group
Video decision aid arm
video decision aid
cpr video decision aid
Interventions
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video decision aid
cpr video decision aid
Eligibility Criteria
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Inclusion Criteria
1. Over the age of 60
2. The ability to provide informed consent
3. The ability to communicate in English
4. An established diagnosis of metastatic cancer with a prognosis of one year or less confirmed with the attending physician on service.
21 Years
ALL
No
Sponsors
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Stanford University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Angelo E. Volandes, MD
Principal Investigator
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Angelo Volandes, MD
Role: primary
Other Identifiers
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2011P000010
Identifier Type: -
Identifier Source: org_study_id