Principal Investigator: John  Ryan
Keywords: Pulmonary Hypertension Department: Cardiovascular Medicine
IRB Number: 00104096
Specialty: Cardiology, Pulmonary
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Brittany Penn
brittany.penn@hsc.utah.edu
8015852469

Brief Summary

PHAR Objectives
The goals of the PHAR include 1) measuring and improving quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes), 2) determining the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches, 3) understanding risk factors for outcomes and regional/center differences, and 4) facilitating funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.

Inclusion Criteria

Criteria Eligibility Criteria 
Medical records for PAH or CTEPH patients undergoing initial evaluation at a PHCC outpatient clinic should be screened to determine if eligibility criteria for the PHAR are met (or may be met after further evaluation).
The PHAR will enroll patients who meet the following inclusion criteria:
1. New patients to a PHA Care Center with either newly diagnosed or established PAH or CTEPH (within 6 months of first outpatient visit at the PHCC).
2. Informed consent for data to be abstracted and included in the PHAR provided by the patient or guardian.
3. Able to understand and speak either English or Spanish.

Exclusion Criteria

Clarification of Selected Issues
1. Patients must be “new” to the center
The PHAR defines “new” patients as those who are enrolled within six months of their first outpatient visit to the center (either as a newly diagnosed or new-to-the-center patient (the latter category could include patients who transferred their care to the PHCC due to a referral, a change in their insurance coverage, or to see a new physician)). The six month term is defined as 26 weeks from the date of the patient’s first outpatient visit to the center. “Enrollment” refers to the signing of the informed consent form and the completion of the baseline questionnaire. Both tasks must be completed within the six month window.
The PHAR includes only new participants at each center in an attempt to reduce problems that could arise from applying current guidelines to patients who were initially evaluated in the distant past. Focusing on new patients minimizes the burden of missing data and avoids the impression of practice deviations for patients evaluated in a different diagnostic and treatment era.
2. Patients must be diagnosed with either PAH or CTEPH
Practitioners should only enroll patients diagnosed with either Group 1 (PAH) or Group 4 (CTEPH) pulmonary hypertension, as defined by the World Health Organization Nice 2013 Classification (Appendix H). The PHAR will currently enroll only PAH and CTEPH patients, given the availability of consensus-based guidelines for appropriate care of these types of pulmonary hypertension and the existing management options.
It is recognized that while diagnostic criteria exist and are important (e.g., hemodynamic criteria), PAH and CTEPH are ultimately clinical diagnoses. While the PHAR does not provide strict diagnostic parameters in the inclusion criteria, the level of adherence of the PHCC to standard diagnostic guidelines for these conditions will be assessed (and serve as one of the criteria for reaccreditation).
3. Vulnerable populations
Pregnant women are eligible for enrollment. Patients using investigational drugs are also eligible for enrollment. Patients who are visually impaired or otherwise physically impaired (e.g., limited dexterity) may be enrolled if clinic staff members are able to read the questions aloud and enter patient responses. Patients who are decisionally impaired (e.g. patients with Down syndrome, etc.) may be enrolled if approved by the site’s IRB and if parent/guardian/caregiver consent is obtained.