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Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers

Primary Purpose

Cardiovascular Risk Factors, Coronary Disease, Cardiac Arrest

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

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors

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

  • Penn Presbyterian Medical Center
  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard CPR

Recruitment with Volunteers

Recruitment with Nurses

Chest Compressions Only CPR

Arm Description

Individuals will learn the Standard form of CPR (30:2, compressions:breathes) Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills

UPHS volunteer subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.

UPHS Nurse subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.

Individuals will learn the chest compression only form of CPR (no rescue breathes) Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills

Outcomes

Primary Outcome Measures

Assessing Nurses and Volunteers implementation of the in-hospital CPR Training Program
To determine if volunteers or nursing staff can adequately implement a CPR Training Program for at risk family members of patients hospitalized for cardiac risk-factors. Subjects will be given "enroller surveys" in 3-month integrals to assess comfort level with the program.

Secondary Outcome Measures

CPR Skills Performance and Retention
To assess skill performance by subject family members and retention with chest compression only CPR versus standard CPR education. Subjects will be asked to perform 2 minutes of CPR on a Laerdal SkillReporter ResusciAnne mannequin.
Assessing bystander CPR training dissemination
To quantify the multiplier effect, an assessment of the number of people who received secondary CPR training via CPR Anytime kits shared with them by study subjects.

Full Information

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

Unique Protocol Identification Number
NCT01252316
Brief Title
Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers
Official Title
An In-Hospital VSI CPR Dissemination Study Using Nurses and Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Each year in the United States, 300,000 people suffer from 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 Associations (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. The unique feature of the CPR Anytime training is that it is a low-cost, self-learning, video-based program that can be completed in under 30 minutes, saving the time and expense of traditional CPR training courses. While initial work has proven that teaching CPR in hospital using the VSI kit is feasible, little research has been conducted to make the program sustainable.
Detailed Description
The long term goal of our work is to implement real world CPR training strategies that match training locales with at-risk populations, maximize resuscitation skill retention, and promote willingness to act. To accomplish this, we will empower stakeholders at UPHS hospitals to develop local implementation approaches, using either UPHS volunteers or nursing staff as VSI proctors. These stakeholders will be studied as a research subset. The VSI proctors will use the AHAs CPR Anytime kit, and will work with family members of patients at high risk for a CA to learn lifesaving CPR skills. We will use a modified AHA CPR video using the new AHA recommendations for bystanders which suggests doing chest compression only CPR. Using the original AHA video and the modified chest compression only video, we will randomize family members of patients at high risk for CA to one of these groups. The VSI proctors will also be blinded to which video these subjects will be watching. We will follow up with the family members at 1 month, 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. We will also assess the perceptions and attitudes of the nurses and volunteers regarding this project.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
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 at various increments over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills
Arm Title
Recruitment with Volunteers
Arm Type
Active Comparator
Arm Description
UPHS volunteer subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.
Arm Title
Recruitment with Nurses
Arm Type
Active Comparator
Arm Description
UPHS Nurse subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.
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 over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills
Intervention Type
Other
Intervention Name(s)
CPR Training using the Family and Friends CPR Anytime VSI Kit
Intervention Description
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. The subject's will undergo training in-hospital then they will be encouraged to take the kit home with them to practice CPR with their family members and friends.
Intervention Type
Other
Intervention Name(s)
Implementation of an In-Hospital CPR Training Model
Intervention Description
UPHS Nurses and Volunteers will be trained in our in-hospital CPR Training Model using VSI Kits, and encouraged to implement the training program in their respective hospitals.
Primary Outcome Measure Information:
Title
Assessing Nurses and Volunteers implementation of the in-hospital CPR Training Program
Description
To determine if volunteers or nursing staff can adequately implement a CPR Training Program for at risk family members of patients hospitalized for cardiac risk-factors. Subjects will be given "enroller surveys" in 3-month integrals to assess comfort level with the program.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
CPR Skills Performance and Retention
Description
To assess skill performance by subject family members and retention with chest compression only CPR versus standard CPR education. Subjects will be asked to perform 2 minutes of CPR on a Laerdal SkillReporter ResusciAnne mannequin.
Time Frame
up to 1 year
Title
Assessing bystander CPR training dissemination
Description
To quantify the multiplier effect, an assessment of the number of people who received secondary CPR training via CPR Anytime kits shared with them by study subjects.
Time Frame
up to 1 year

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
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

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Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers

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