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

NCT ID: NCT02407431

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2030-07-31

Brief 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.

Detailed 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?

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Kathleen McTigue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen McTigue, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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, United States

Countries

United States

Other Identifiers

CDRN-1306-04912

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY20110299

Identifier Type: -

Identifier Source: org_study_id