A Prospective Randomized Trial Using Video Images in Advance Care Planning in Seriously Ill Hospitalized Patients
NCT ID: NCT01325519
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
2011-03-31
Brief Summary
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Detailed Description
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Hypothesis 1: It is feasible to recruit and randomize 150 hospitalized subjects with an overall prognosis of one year or less.
A.2. 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.
A.3. 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.
A.4. 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.
A.5. 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.
A.6. 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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no intervention control group
control subjects
No interventions assigned to this group
experimental intervention group
video decision aid viewed by subjects
video decision aid
video
Interventions
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video decision aid
video
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The ability to provide informed consent
3. The ability to communicate in English
4. And one of the following:
1. An established diagnosis of metastatic cancer or
2. An established diagnosis of advanced heart failure (NYHA class III/IV heart failure) or
3. An established diagnosis of chronic obstructive lung disease with an FEV1 \< 50% or
4. Two hospitalizations within the last 6 months or
5. An advanced illness or multiple comorbidities that are not otherwise specified with an overall prognosis of one year or less confirmed with the attending physician on service. Exclusion Criterion
1\. Subject scores 6 or less on the Short Portable Mental Status Questionnaire, which is indicative of cognitive impairment.
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Angelo E. Volandes, MD
PI
Locations
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MGH
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Angelo Volandes
Role: primary
References
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El-Jawahri A, Mitchell SL, Paasche-Orlow MK, Temel JS, Jackson VA, Rutledge RR, Parikh M, Davis AD, Gillick MR, Barry MJ, Lopez L, Walker-Corkery ES, Chang Y, Finn K, Coley C, Volandes AE. A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients. J Gen Intern Med. 2015 Aug;30(8):1071-80. doi: 10.1007/s11606-015-3200-2. Epub 2015 Feb 18.
Other Identifiers
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2010P002794
Identifier Type: -
Identifier Source: org_study_id