- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01252316
Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers
October 31, 2018 updated by: University of Pennsylvania
An In-Hospital VSI CPR Dissemination Study Using Nurses and Volunteers
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Philadelphia, Pennsylvania, United States, 19106
- Pennsylvania Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard CPR
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
|
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.
|
|
Active Comparator: Recruitment with Volunteers
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 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.
|
|
Active Comparator: Recruitment with Nurses
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.
|
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.
|
|
Active Comparator: Chest Compressions Only CPR
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing Nurses and Volunteers implementation of the in-hospital CPR Training Program
Time Frame: 2 years
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPR Skills Performance and Retention
Time Frame: up to 1 year
|
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.
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up to 1 year
|
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Assessing bystander CPR training dissemination
Time Frame: up to 1 year
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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.
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up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
November 30, 2010
First Posted (Estimate)
December 2, 2010
Study Record Updates
Last Update Posted (Actual)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 31, 2018
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRS-812096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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