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An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program

Primary Purpose

Cardiac Arrest, Coronary Disease, Cardiovascular Risk Factors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CPR Training using the Family and Friends CPR Anytime VSI Kit
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.

Exclusion Criteria:

  • If someone is physically unable to undergo CPR Training
  • Someone who has received CPR training in the past 2 years

Sites / Locations

  • Hospital of the University of Pennsylvania
  • Penn Presbyterian Medical Center
  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard CPR

Chest Compressions Only CPR

Arm Description

Individuals will learn the Standard form of CPR (30:2, compressions:breathes) Main data points being collected over various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills

Individuals will learn the chest compression only form of CPR (no rescue breathes) Main data points being collected at various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills

Outcomes

Primary Outcome Measures

Subject Self-Confidence
We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills.
Secondary Training
In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit.

Secondary Outcome Measures

Assessing CPR Skills
We will assess the subject's CPR skills by administering a 2-minute simulated CPR skills check recorded on a Laerdal Skillreporter ResusciAnne mannequin and video camera. The skills check will be conducted initially post training and at the 3-, 6-, and 12-month time frame.

Full Information

First Posted
November 29, 2010
Last Updated
October 31, 2018
Sponsor
University of Pennsylvania
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01260441
Brief Title
An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program
Official Title
CPR Education of Patient Family Members Using CPR Anytime Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5% survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR. Studies have shown that prompt administration of CPR dramatically improves outcomes. In a recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our study will look to train family members of at-risk cardiac patients in the skills of CPR through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal Learning Program (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the event that their family member should suffer a cardiac arrest.
Detailed Description
Using the AHA's CPR Anytime kit, we will work with family members of patients at high risk for a CA to learn lifesaving CPR skills. We will modify the AHA CPR video using the new AHA recommendations for bystanders which suggests doing chest compression only CPR. Using the original AHA video and our modified chest compression only video, we will randomize family members of patients at high risk for CA to one of these groups. Our research assistants will also be blinded to which video these subjects will be watching. After watching the video, we will have the subjects perform CPR on a mannequin using a CPR recording device that records chest compression rate and depth. We will follow up with the family members at 3 months, 6 months and 12 months to see if they retained their CPR knowledge and skills and to see if they had been in a situation where their CPR skills were needed and assess whether they performed their skills or not. We will also measure the number of people with whom the subjects shared their CPR Anytime kits-a quantity known as the multiplier effect to determine if they had shared the CPR Anytime kit with their family and friends, thereby increasing the possible number of lay persons trained in CPR and in turn able to perform bystander CPR if needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Coronary Disease, Cardiovascular Risk Factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard CPR
Arm Type
Active Comparator
Arm Description
Individuals will learn the Standard form of CPR (30:2, compressions:breathes) Main data points being collected over various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills
Arm Title
Chest Compressions Only CPR
Arm Type
Active Comparator
Arm Description
Individuals will learn the chest compression only form of CPR (no rescue breathes) Main data points being collected at various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills
Intervention Type
Other
Intervention Name(s)
CPR Training using the Family and Friends CPR Anytime VSI Kit
Other Intervention Name(s)
Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)
Intervention Description
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
Primary Outcome Measure Information:
Title
Subject Self-Confidence
Description
We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills.
Time Frame
within 30 minutes of CPR training
Title
Secondary Training
Description
In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit.
Time Frame
3 month increments over a 12 month period of time
Secondary Outcome Measure Information:
Title
Assessing CPR Skills
Description
We will assess the subject's CPR skills by administering a 2-minute simulated CPR skills check recorded on a Laerdal Skillreporter ResusciAnne mannequin and video camera. The skills check will be conducted initially post training and at the 3-, 6-, and 12-month time frame.
Time Frame
3 to 6 months post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension. Exclusion Criteria: If someone is physically unable to undergo CPR Training Someone who has received CPR training in the past 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin S Abella, MD, MPhil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22080629
Citation
Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.
Results Reference
derived

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An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program

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