- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570947
CPR Prescription Program
In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Participants will be given the pharmacy locations where they can be purchased. Optimally they will complete the program at home with their family.
Research Hypothesis:
- Families of patients at risk for coronary artery disease can be motivated to learn CPR by receiving a prescription for a CPR Anytime ™ self learning kit.
- As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR.
- Families may experience a "teachable moment" when their loved one is in the emergency department. In comparison to the office settings, this may increase the likelihood that they fill the prescription for CPR Anytime® and complete the learning kit.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a prospective study of patients presenting to one of three recruiting sites (emergency department and office based primary care/cardiology settings). Physicians at all settings will agree to be a part of the Physician CPR Prescription program. Participating physicians are provided with a description of the Physician CPR Prescription program and pre-printed CPR prescription pads. The front side of the prescription is preprinted with the information needed to obtain CPR Anytime ™ for Friends and Family. The back of the prescription is preprinted with "Quick Facts" to assist the physician in delivering a consistent and persuasive CPR message to patients and their families.
After consent, participants will be randomized to one of two groups. The control group will be advised to take a traditional CPR class and be offered a list of local classes. Phone follow up at approximately 3 months will assess their participation. The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program. Follow up phone survey at approximately three months will assess compliance with physician recommendations to fill the prescription, as well as actual completion of the materials (and possible multiplier effect).
Comparisons between the sites regarding efficacy of prescribing will be performed. Results will be reported as mean +/- standard deviation, % or frequencies to summarize patient characteristics. One way ANOVA will be used to compare the three groups for continuous data and chi-square for categorical data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking
- 45 or older
- Competent outpatient.
- Have DVD access in home.
- Willing to fill prescriptions at Spectrum pharmacy.
- Never had CPR, or CPR greater than 1 year ago.
- Have a risk factor for heart disease or have heart disease.
Exclusion Criteria:
- Non English speaking
- Minors
- Incompetent or significantly ill/distressed
- No DVD access
- Unwilling to fill rx at spectrum.
- CPR less than 1 year ago.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Class
The control group will be advised to take a traditional CPR class and be offered a list of local classes.
|
The study group will be asked to fill the CPR Anytime ™ prescription and complete the program.
They will be encouraged to include other friends and family members in the program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Completion of CPR
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Family Member completion of CPR
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marna R Greenberg, D.O., LVH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-20070910
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.
Clinical Trials on Prevention of Sudden Death
-
Lehigh Valley HospitalCompletedPrevention of Sudden DeathUnited States
-
Boston Scientific CorporationCompletedPrimary Prevention of Sudden Cardiac Arrest | Secondary Prevention of Sudden Cardiac ArrestUnited States
-
Boston Scientific CorporationCompletedPrimary Prevention of Sudden Cardiac Arrest | Secondary Prevention of Sudden Cardiac ArrestUnited States, Canada, Australia
-
Boston Scientific CorporationCompletedPrimary Prevention of Sudden Cardiac ArrestUnited States
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceRecruitingHeart Failure | Implantable Cardioverter Defibrillator | Primary Prevention of Sudden Cardiac DeathFrance
-
Catholic University of the Sacred HeartTexas Cardiac Arrhythmia Research Foundation; Cardiac Arrhythmia Research Center... and other collaboratorsUnknownDilated Cardiomyopathy | Implantable Cardioverter Defibrillator | Primary Prevention of Sudden Cardiac DeathItaly, United States
-
Keimyung University Dongsan Medical CenterMedtronicTerminatedPrimary Prevention | Valvular Heart Disease | Sudden Cardiac Death | Implantable Cardioverter DefibrillatorKorea, Republic of
-
Biotronik SE & Co. KGCompletedTachycardia, Ventricular | Primary Prevention | Sudden Cardiac DeathIsrael, Germany, Hungary, Switzerland, Austria, Czech Republic, Latvia, New Zealand, Poland, Slovakia, Spain
-
Seattle Institute for Cardiac ResearchNational Institutes of Health (NIH); Abbott Medical DevicesUnknownCongestive Heart Failure | Left Ventricular Systolic Dysfunction | Ischemic and Non-ischemic Cardiomyopathy | Sudden Cardiac Death Primary PreventionUnited States
-
National Taiwan University HospitalUnknownOut-of-Hospital Cardiac Arrest | Sudden Cardiac DeathTaiwan
Clinical Trials on CPR Anytime Kit
-
University of PennsylvaniaCompletedHeart Disease | Cardiac ArrestUnited States
-
University of PennsylvaniaAmerican Heart AssociationCompletedCoronary Disease | Cardiac Arrest | Cardiovascular Risk FactorsUnited States
-
University of PennsylvaniaPatient-Centered Outcomes Research InstituteCompletedCoronary Disease | Cardiac Arrest | Cardiovascular Risk FactorsUnited States
-
Lehigh Valley HospitalCompletedPrevention of Sudden DeathUnited States
-
University of PennsylvaniaCompletedCoronary Disease | Cardiac Arrest | Cardiovascular Risk FactorsUnited States
-
Marna Rayl GreenbergCompletedCoronary Atherosclerosis | Prevention of Heart DiseaseUnited States
-
University of PennsylvaniaCompletedCoronary Disease | Cardiac Arrest | Cardiovascular Risk FactorsUnited States
-
Karolinska InstitutetSwedish Heart Lung FoundationCompletedCardiac Arrest | Out of Hospital Cardiac ArrestSweden
-
Siriraj HospitalCompletedEmergency Medical Services | Out-of-hospital Cardiac Arrest (OHCA)Thailand