PaTH Clinical Data Research Network (CDRN) Idiopathic Pulmonary Fibrosis (IPF) Clinician Patient Partnership Cohort

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

PaTH Clinical Data Research Network (CDRN) Idiopathic Pulmonary Fibrosis (IPF) Clinician Patient Partnership Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02407431
• Other study ID #: STUDY20110299
• Secondary ID: CDRN-1306-04912
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• 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 IPF 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 with Idiopathic Pulmonary Fibrosis, providers, and other stakeholders.

Description:

The primary objective is to create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network. Creating the IPF Clinician-Patient Partnership Cohort will involve: 1. Recruiting patients with IPF to participate in the PaTH Network IPF Clinician-Patient Partnership Cohort 2. Administering surveys to the IPF Clinician-Patient Partnership Cohort approximately every 3 months to collect patient reported outcomes (PROs) 3. Merging individual patient health record data into the IPF 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. Determining if an automated procedure for identifying duplicate patients across PaTH institutions without the use of protected health information (PHI) is valid compared to a manual matching procedure using PHI. 6. Identifying potential participants for future research studies. The secondary objectives are to use the PaTH Network IPF Clinician-Patient Partnership Cohort to answer patient-centered research questions including: 1. What is the prevalence of gastroesophageal reflux disease (GERD) in IPF, and what effect does GERD and its treatment have on IPF disease progression, quality of life, and survival? 2. What is the association of oxygen use with survival, quality of life, exercise tolerance, neurocognitive function, and dyspnea? 3. How often do IPF patients have advance directives, how often are advance directives documented in the electronic health record, and does having an advance directive influence how/where IPF patients die, their health care utilization, satisfaction with care, and quality of life?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• The target study population is adults identified as having IPF (through the PaTH IPF computable phenotype algorithm or a local IPF registry).

Exclusion Criteria:

• Age <18 years
• Deceased
• Not proficient in English
• Has not had at least one outpatient encounter in the past 18 months at the PaTH health system's pulmonary specialty clinic through which they are recruited
• Lung transplant
• Already enrolled in the PaTH Clinician-Patient Partnership Cohort at another PaTH institution

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

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
United States	University of Utah	Salt Lake City	Utah

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create PaTH Network IPF Clinician-Patient Partnership Cohort	Create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.	18 months