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A Prospective Randomized Trial Using Video Images in Advance Care Planning in Seriously Ill Hospitalized Patients

Mass General Brigham logo

Mass General Brigham

Status

Unknown

Conditions

Video Decision Aids
Decision Making

Treatments

Other: video decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01325519
2010P002794

Details and patient eligibility

About

The purpose of this study is to compare the decision making of hospitalized subjects having a verbal discussion about CPR compared to subjects using a video.

Full description

A.1. Aim 1: To recruit 150 subjects admitted to the inpatient general medicine ward with an overall prognosis of one year or less and randomly assign these subjects to: 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 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.

Enrollment

150 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  1. Over the age of 60

  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
  5. Subject scores 6 or less on the Short Portable Mental Status Questionnaire, which is indicative of cognitive impairment.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 2 patient groups

no intervention control group
No Intervention group
Description:
control subjects
experimental intervention group
Experimental group
Description:
video decision aid viewed by subjects
Treatment:
Other: video decision aid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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