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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02485288
• Other study ID #: STUDY20110294
• Status: Active, not recruiting
• Start date: June 2015
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Jody McCullough	Hershey	Pennsylvania
United States	Anuradha Paranjape	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Johns Hopkins University, Penn State University, Temple University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Han HR, Jain SK, Naccarelli GV, Aggarwal V, Nazarian S. Association of sex, age and education level with patient reported outcomes in atrial fibrillation. BMC Cardiovasc Disord. 2019 Apr 5;19(1):85. doi: 10.1186/s12872-019-1059-6. — View Citation

Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Jain S, Naccarelli G, Aggarwal V, Nazarian S. Association of sex and atrial fibrillation therapies with patient-reported outcomes. Heart. 2019 Nov;105(21):1642-1648. doi: 10.1136/heartjnl-2019-314881. Epub 2019 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort	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.	18 months