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Clinical Trials/NCT01653938
NCT01653938
Unknown
Not Applicable

A Randomized Controlled Trial of a CPR Video in Heart Failure Patients

Massachusetts General Hospital1 site in 1 country50 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congestive Heart Failure
Sponsor
Massachusetts General Hospital
Enrollment
50
Locations
1
Primary Endpoint
preferences
Last Updated
5 years ago

Overview

Brief Summary

This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).

Detailed Description

Aim 1: 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 1: 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 2: 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 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video. Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video. Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
September 2012
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angelo E. Volandes, MD

PI

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of advanced heart failure:
  • New York Heart Association Class III or IV (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest). AND
  • Two or more hospitalizations for heart failure in the last year. AND
  • Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
  • Ability to provide informed consent.
  • Ability to communicate in English.
  • Age 65 or older.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

preferences

Time Frame: 5 minutes after survey

preferences for cpr and intubation

Secondary Outcomes

  • knowledge(5 minutes after survey)
  • decisional conflict(5 minutes after survey)
  • advance care planning documentation(by the end of one year)

Study Sites (1)

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