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PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort

Sponsor
University of Pittsburgh (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02485288
Collaborator
Johns Hopkins University (Other), Penn State University (Other), Temple University (Other)
1,500
Enrollment
4
Locations
109
Duration (Months)
375
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary objective is to create the PaTH Network AF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on AF across the multiple institutions of the PaTH network. Creating the AF Clinician-Patient Partnership

    Cohort will involve:

    1. Recruiting patients with AF to participate in the PaTH Network AF Clinician-Patient Partnership Cohort

    2. Administering surveys to the AF Clinician-Patient Partnership Cohort approximately every 6 months to collect patient reported outcomes (PROs)

    3. Collecting individual patient health record data into the AF Clinician-Patient Partnership Cohort database

    4. Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.

    5. Identifying potential participants for future research studies.

    The secondary objectives are to use the PaTH Network AF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:

    1. What is the incidence of complications requiring re-hospitalization after an ablation procedure for AF?

    2. What are the predictors of major bleeding and stroke among patients that receive each anticoagulant class (vit K antagonist, direct factor X inhibitor, direct thrombin inhibitor)?

    3. Is the longitudinal change in applied cognition-executive function score in AF patients associated with the choice of rate versus rhythm control and anticoagulation strategy?

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
    Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort [18 months]

      Create the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohortwhich will allow the conduct of patient-centered observational studies on atrial fibrillation across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age: 18 years or older at time of query

    • Visits: 3 non-ED outpatient visits between 1/1/2011 and 12/31/2014

    • AF : AF diagnosis documented between 1/1/2011 and 12/31/2014

    • AF diagnosis can be coded EHR (on billing or problem lists) and/or derived from EKG reports

    • AF diagnoses associated with surgery, certain thyroid conditions, or certain medications cannot count as the qualifying AF diagnosis for inclusion in this cohort.

    Exclusion Criteria:

    • Deceased

    • Not proficient in English

    • Already enrolled in the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort at another PaTH institution

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins University Baltimore Maryland United States 21231
    2 Jody McCullough Hershey Pennsylvania United States 17033
    3 Anuradha Paranjape Philadelphia Pennsylvania United States 19140
    4 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • Johns Hopkins University
    • Penn State University
    • Temple University

    Investigators

    • Principal Investigator: Kathleen M McTigue, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kathleen McTigue, Associate Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT02485288
    Other Study ID Numbers:
    • EXT15060516
    First Posted:
    Jun 30, 2015
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Nov 1, 2021