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

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ClinicalTrials.gov Identifier: NCT02407431
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
Temple University
Johns Hopkins University
Penn State University
University of Utah
Information provided by (Responsible Party):
Kathleen McTigue, University of Pittsburgh

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.

Condition or disease
Idiopathic Pulmonary Fibrosis

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?

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: PaTH Clinical Data Research Network (CDRN) Idiopathic Pulmonary Fibrosis (IPF) Clinician Patient Partnership Cohort
Study Start Date : March 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018





Primary Outcome Measures :
  1. Create PaTH Network IPF Clinician-Patient Partnership Cohort [ Time Frame: 18 months ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target study population is adults with IPF who receive health care at one of the PaTH Network institutions.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407431


Contacts
Contact: Barbara D. Postol, PhD 412-864-3025 postolba2@upmc.edu
Contact: Jody McCullough, AA 717-531-0003 ext 289350 jfenush1@hmc.psu.edu

Locations
United States, Maryland
Johns Hopkins University Completed
Baltimore, Maryland, United States, 21231
United States, Pennsylvania
Jody McCullough Completed
Hershey, Pennsylvania, United States, 17033
Cecilia Dobi Completed
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Completed
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Meghan Lynch    801-587-0494    meghan.lynch@hsc.utah.edu   
Principal Investigator: Rachel Hess, MD         
Sponsors and Collaborators
University of Pittsburgh
Temple University
Johns Hopkins University
Penn State University
University of Utah
Investigators
Principal Investigator: Kathleen McTigue, MD University of Pittsburgh

Responsible Party: Kathleen McTigue, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02407431     History of Changes
Other Study ID Numbers: EXT15030529 CDRN-1306-04912
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial