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

November 16, 2020 updated by: Angelo E. Volandes, MD, Massachusetts General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • MGH
        • Contact:
        • Principal Investigator:
          • Angelo Voalndes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no intervention control group
control subjects
Experimental: experimental intervention group
video decision aid viewed by subjects
Other: video decision aid
video
Other Names:
  • decision aid
  • film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preferences for medical care
Time Frame: within 48 hours of admission to the hospital
preference for CPR
within 48 hours of admission to the hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
knowledge of CPR
Time Frame: baseline and post-intervention
baseline and post-intervention
code status on subsequent admissions
Time Frame: subsequent hospital admissions
subsequent hospital admissions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2010P002794

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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