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A ProspectiveTrial Using Video Images in Advance Care Planning in Hospitalized Seriously Ill Patients With Advanced Cancer

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Mass General Brigham

Status

Unknown

Conditions

Advanced Cancer

Treatments

Behavioral: video decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01527331
2011P000010

Details and patient eligibility

About

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

Full description

Aim 1: To recruit 150 subjects with advanced cancer admitted to the inpatient oncology 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 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.

Enrollment

150 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Potential subjects will be identified by the research assistant. The specific eligibility criteria include:

    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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 2 patient groups

control group
No Intervention group
Description:
usual care
Video decision aid arm
Experimental group
Treatment:
Behavioral: video decision aid

Trial contacts and locations

1

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Central trial contact

Angelo Volandes, MD

Data sourced from clinicaltrials.gov

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