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

Active, not recruiting
Conditions
Atrial Fibrillation
Registration Number
NCT02485288
Lead Sponsor
University of Pittsburgh
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.

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?

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1500
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.
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort18 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

Jody McCullough

🇺🇸

Hershey, Pennsylvania, United States

Anuradha Paranjape

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

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