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

Decision Making Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01325519
• Other study ID #: 2010P002794
• Status: Recruiting
• Phase: N/A
• Start date: March 2011

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Decision Making
• Video Decision Aids

Intervention

Other:
• video decision aid
video

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preferences for medical care	preference for CPR	within 48 hours of admission to the hospital
Secondary	knowledge of CPR		baseline and post-intervention
Secondary	code status on subsequent admissions		subsequent hospital admissions