PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,500
- 试验地点
- 4
- 主要终点
- Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
研究概览
简要总结
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.
详细描述
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:
- Recruiting patients with AF to participate in the PaTH Network AF Clinician-Patient Partnership Cohort
- Administering surveys to the AF Clinician-Patient Partnership Cohort approximately every 6 months to collect patient reported outcomes (PROs)
- Collecting individual patient health record data into the AF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- 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:
- What is the incidence of complications requiring re-hospitalization after an ablation procedure for AF?
- 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)?
- 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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
时间窗: 18 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.
次要结局
未报告次要终点
研究者
Kathleen McTigue
Professor
University of Pittsburgh
