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A Trial of a CPR Video in Heart Failure Patients

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video decision aid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congestive Heart Failure focused on measuring CHF

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Ability to provide informed consent.
  3. Ability to communicate in English.
  4. Age 65 or older.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Video Arm

Arm Description

Use of video decision aid in the experimental arm.

Outcomes

Primary Outcome Measures

preferences
preferences for cpr and intubation

Secondary Outcome Measures

knowledge
knowledge of cpr and intubation
decisional conflict
decisional conflict
advance care planning documentation
advance care planning in medical record

Full Information

First Posted
July 24, 2012
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01653938
Brief Title
A Trial of a CPR Video in Heart Failure Patients
Official Title
A Randomized Controlled Trial of a CPR Video in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
CHF

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Title
Video Arm
Arm Type
Experimental
Arm Description
Use of video decision aid in the experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
video decision aid
Primary Outcome Measure Information:
Title
preferences
Description
preferences for cpr and intubation
Time Frame
5 minutes after survey
Secondary Outcome Measure Information:
Title
knowledge
Description
knowledge of cpr and intubation
Time Frame
5 minutes after survey
Title
decisional conflict
Description
decisional conflict
Time Frame
5 minutes after survey
Title
advance care planning documentation
Description
advance care planning in medical record
Time Frame
by the end of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
Phone
617-643-4266
Email
avolandes@partners.org
First Name & Middle Initial & Last Name & Degree
Angelo Volandes

12. IPD Sharing Statement

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A Trial of a CPR Video in Heart Failure Patients

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