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

March 28, 2011
January 26, 2012
March 2011
March 2012   (final data collection date for primary outcome measure)
preferences for medical care [ Time Frame: within 48 hours of admission to the hospital ] [ Designated as safety issue: No ]
preference for CPR
Same as current
Complete list of historical versions of study NCT01325519 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
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A Prospective Randomized Trial Using Video Images in Advance Care Planning in Seriously Ill Hospitalized Patients
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Decision Making
  • Video Decision Aids
Other: video decision aid
video
Other Names:
  • decision aid
  • film
  • No Intervention: no intervention control group
    control subjects
  • Experimental: experimental intervention group
    video decision aid viewed by subjects
    Intervention: Other: video decision aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
March 2012   (final data collection date for primary outcome measure)

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.

Both
60 Years and older
No
United States
 
NCT01325519
2010P002794
No
Angelo E. Volandes, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP