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CPR Prescription Program

Primary Purpose

Prevention of Sudden Death

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPR Anytime Kit
Sponsored by
Lehigh Valley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Sudden Death focused on measuring CPR Anytime

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 10, 2007
    Last Updated
    April 25, 2012
    Sponsor
    Lehigh Valley Hospital
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    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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