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An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome (PROMOTION)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring patient education, acute coronary syndrome, prehospital delay to treatment

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a diagnosis of ischemic heart disease, confirmed by their physician or medical record
  • lived independently (i.e., not in an institutional setting).

Exclusion Criteria:

  • complicating serious co-morbidity such as a psychiatric illness or untreated malignancy
  • neurological disorder with impaired cognition
  • inability to read or understand English.
  • major uncorrected hearing loss

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A

    B

    Arm Description

    a tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days

    care-as-usual with data collection at the same time points as the experimental group

    Outcomes

    Primary Outcome Measures

    time from ACS symptom onset to admission to emergency department

    Secondary Outcome Measures

    pre-hospital aspirin use
    emergency medical system use
    resource utilization

    Full Information

    First Posted
    August 12, 2008
    Last Updated
    August 12, 2008
    Sponsor
    University of California, San Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00734760
    Brief Title
    An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome
    Acronym
    PROMOTION
    Official Title
    Reducing Prehospital Delay in Acute Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.
    Detailed Description
    Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary & Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome
    Keywords
    patient education, acute coronary syndrome, prehospital delay to treatment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3522 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    a tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days
    Arm Title
    B
    Arm Type
    No Intervention
    Arm Description
    care-as-usual with data collection at the same time points as the experimental group
    Intervention Type
    Behavioral
    Intervention Name(s)
    education
    Other Intervention Name(s)
    none applicable
    Intervention Description
    face-to-face education and counseling intervention
    Primary Outcome Measure Information:
    Title
    time from ACS symptom onset to admission to emergency department
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    pre-hospital aspirin use
    Time Frame
    two years
    Title
    emergency medical system use
    Time Frame
    two years
    Title
    resource utilization
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a diagnosis of ischemic heart disease, confirmed by their physician or medical record lived independently (i.e., not in an institutional setting). Exclusion Criteria: complicating serious co-morbidity such as a psychiatric illness or untreated malignancy neurological disorder with impaired cognition inability to read or understand English. major uncorrected hearing loss
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen A Dracup, DNSc
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18504332
    Citation
    Dracup K, McKinley S, Doering LV, Riegel B, Meischke H, Moser DK, Pelter M, Carlson B, Aitken L, Marshall A, Cross R, Paul SM. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008 May 26;168(10):1049-54. doi: 10.1001/archinte.168.10.1049.
    Results Reference
    background
    PubMed Identifier
    18507563
    Citation
    Aitken LM, Pelter MM, Carlson B, Marshall AP, Cross R, McKinley S, Dracup K. Effective strategies for implementing a multicenter international clinical trial. J Nurs Scholarsh. 2008;40(2):101-8. doi: 10.1111/j.1547-5069.2008.00213.x.
    Results Reference
    background
    PubMed Identifier
    18022812
    Citation
    Riegel B, McKinley S, Moser DK, Meischke H, Doering L, Dracup K. Psychometric evaluation of the Acute Coronary Syndrome (ACS) Response Index. Res Nurs Health. 2007 Dec;30(6):584-94. doi: 10.1002/nur.20213.
    Results Reference
    background
    PubMed Identifier
    16699358
    Citation
    Dracup K, McKinley S, Riegel B, Mieschke H, Doering LV, Moser DK. A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial. J Cardiovasc Nurs. 2006 May-Jun;21(3):186-93. doi: 10.1097/00005082-200605000-00006.
    Results Reference
    background
    PubMed Identifier
    20031889
    Citation
    Dracup K, McKinley S, Riegel B, Moser DK, Meischke H, Doering LV, Davidson P, Paul SM, Baker H, Pelter M. A randomized clinical trial to reduce patient prehospital delay to treatment in acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):524-32. doi: 10.1161/CIRCOUTCOMES.109.852608. Epub 2009 Oct 6.
    Results Reference
    derived

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    An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome

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