CPR Prescription Program
Primary Purpose
Prevention of Sudden Death
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPR Anytime Kit
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Sudden Death focused on measuring CPR Anytime
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Class
Arm Description
The control group will be advised to take a traditional CPR class and be offered a list of local classes.
Outcomes
Primary Outcome Measures
Completion of CPR
Secondary Outcome Measures
Family Member completion of CPR
Full Information
NCT ID
NCT00570947
First Posted
December 10, 2007
Last Updated
April 25, 2012
Sponsor
Lehigh Valley Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00570947
Brief Title
CPR Prescription Program
Official Title
CPR Prescription Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lehigh Valley Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Sudden Death
Keywords
CPR Anytime
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Class
Arm Type
Active Comparator
Arm Description
The control group will be advised to take a traditional CPR class and be offered a list of local classes.
Intervention Type
Other
Intervention Name(s)
CPR Anytime Kit
Intervention Description
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
Primary Outcome Measure Information:
Title
Completion of CPR
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Family Member completion of CPR
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marna R Greenberg, D.O.
Organizational Affiliation
LVH
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CPR Prescription Program
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