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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01252316
Other study ID # CRS-812096
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2010
Est. completion date October 2012

Study information

Verified date December 2015
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
CPR Training using the Family and Friends CPR Anytime VSI Kit
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.
Implementation of an In-Hospital CPR Training Model
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.

Locations

Country Name City State
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Secondary 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. up to 1 year
Secondary 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. up to 1 year
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