CPR Prescription Program

Prevention of Sudden Death Clinical Trial

Official title:

CPR Prescription Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570947
• Other study ID #: 2-20070910
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: April 25, 2012
• Start date: December 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2012
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Death, Sudden
• Prevention of Sudden Death

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lehigh Valley Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of CPR		3 months	No
Secondary	Family Member completion of CPR		3 months	No