BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00587938
Collaborator
(none)
200
1
15
13.3

Study Details

Study Description

Brief Summary

Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF). Limited information is available regarding economic outcomes attributable to BNP assay. The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded. BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported. ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level. Primary outcome was mean total hospital cost per subject. Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay. Differences between groups were compared by t-test with bootstrap. Costs reflect 2005 constant dollars.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
    Study Start Date :
    Dec 1, 2003
    Actual Primary Completion Date :
    Mar 1, 2005
    Actual Study Completion Date :
    Mar 1, 2005

    Arms and Interventions

    Arm Intervention/Treatment
    A

    BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition.

    B

    BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition.

    Outcome Measures

    Primary Outcome Measures

    1. Mean total hospital cost per subject [spans from ED eval through hospitalization discharge]

    Secondary Outcome Measures

    1. Included admission rate, service assignment, discharge diagnosis, and length of stay. [from ED evaluation through hospitalization discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.
    Exclusion Criteria:
    • hemodynamically unstability

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Marys Hospital, Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Raquel M Schears, MD, MPH, Mayo Clinic
    • Principal Investigator: Alfredo L Clavell, MD, Mayo Clinic
    • Study Chair: Lyle J Olsen, MD, Mayo Clinic
    • Study Director: Paula J Santrach, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00587938
    Other Study ID Numbers:
    • 1780-03
    First Posted:
    Jan 8, 2008
    Last Update Posted:
    Jan 8, 2008
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 8, 2008