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CPR Prescription Program
This study is enrolling participants by invitation only.
Sponsored by: Lehigh Valley Hospital
Information provided by: Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00570947
  Purpose

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:

  1. 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.
  2. As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR.
  3. 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.

Condition Intervention
Prevention of Sudden Death
 Other: CPR Anytime Kit

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: CPR Prescription Program

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Completion of CPR [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Family Member completion of CPR [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Class: Active Comparator
The control group will be advised to take a traditional CPR class and be offered a list of local classes.
Other: CPR Anytime Kit
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570947

Sponsors and Collaborators
Lehigh Valley Hospital
Investigators
Principal Investigator: Marna R Greenberg, D.O. LVH
  More Information

Responsible Party: LVHHN ( Marna Rayl Greenberg, D.O., FACEP )
Study ID Numbers: 2-20070910
Study First Received: December 10, 2007
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00570947  
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
CPR Anytime

Study placed in the following topic categories:
Death
Death, Sudden

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009



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