Cardiovascular Risk FactorsPhase 1/2NCT01252316
Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers
A Phase 1/2 study testing CPR Training using the Family and Friends CPR Anytime VSI Kit and Implementation of an In-Hospital CPR Training Model in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Coronary Disease, Cardiac Arrest
- What is being tested?
- CPR Training using the Family and Friends CPR Anytime VSI Kit and Implementation of an In-Hospital CPR Training Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family Member's of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Who cannot join
- If someone is physically unable to undergo CPR Training
- Someone who has received CPR training in the past 2 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
About this study
Official title: 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.
Read the 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.
- Being tested
- CPR Training using the Family and Friends CPR Anytime VSI Kit, Implementation of an In-Hospital CPR Training Model
- Medical subject headings
- Coronary Disease, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR Training using the Family and Friends CPR Anytime VSI KitOther
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 ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard CPR | Active comparator | 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 Receives: Other: CPR Training using the Family and Friends CPR Anytime VSI Kit |
| Recruitment with Volunteers | Active comparator | 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. Receives: Other: Implementation of an In-Hospital CPR Training Model |
| Recruitment with Nurses | Active comparator | 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. Receives: Other: Implementation of an In-Hospital CPR Training Model |
| Chest Compressions Only CPR | Active comparator | 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 Receives: Other: CPR Training using the Family and Friends CPR Anytime VSI Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: up to 1 year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin S Abella, MD, MPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252316
- Sponsor's protocol ID
- CRS-812096
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2010
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-Hospital VSI CPR Dissemination Study Using Nurses and Volunteers
- ClinicalTrials.gov ID
- NCT01252316
- Acronym / sponsor ID
- CRS-812096
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard CPR | Active comparator | Other: CPR Training using the Family and Friends CPR Anytime VSI KitIndividuals 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 |
| Recruitment with Volunteers | Active comparator | Other: Implementation of an In-Hospital CPR Training ModelUPHS 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. |
| Recruitment with Nurses | Active comparator | Other: Implementation of an In-Hospital CPR Training ModelUPHS 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. |
| Chest Compressions Only CPR | Active comparator | Other: CPR Training using the Family and Friends CPR Anytime VSI KitIndividuals 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family Member's of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Key exclusion criteria (2 listed)
- If someone is physically unable to undergo CPR Training
- Someone who has received CPR training in the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPR Training using the Family and Friends CPR Anytime VSI KitSubjects 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. | Other | Chest Compressions Only CPR, Standard CPR |
| Implementation of an In-Hospital CPR Training ModelUPHS 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. | Other | Recruitment with Nurses, Recruitment with Volunteers |
Primary outcome
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 secondary outcomes
CPR Skills Performance and Retention
Time frame: up to 1 year
Assessing bystander CPR training dissemination
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin S Abella, MD, MPhil principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CPR Training using the Family and Friends CPR Anytime VSI Kit and Implementation of an In-Hospital CPR Training Model in people with Cardiovascular Risk Factors and Coronary Disease, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Nurses and Volunteers implementation of the in-hospital CPR Training Program (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.