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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01325519
First received: March 28, 2011
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Decision Making
Video Decision Aids
Other: video decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • preferences for medical care [ Time Frame: within 48 hours of admission to the hospital ] [ Designated as safety issue: No ]
    preference for CPR


Secondary Outcome Measures:
  • knowledge of CPR [ Time Frame: baseline and post-intervention ] [ Designated as safety issue: No ]
  • code status on subsequent admissions [ Time Frame: subsequent hospital admissions ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325519

Locations
United States, Massachusetts
MGH Recruiting
Boston, Massachusetts, United States, 02114
Contact: Angelo Volandes       avolandes@partners.org   
Principal Investigator: Angelo Voalndes         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Angelo E. Volandes, MD, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01325519     History of Changes
Other Study ID Numbers: 2010P002794
Study First Received: March 28, 2011
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014