Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)

Status:	Active, not recruiting
Conditions:	Peripheral Vascular Disease
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - Any
Updated:	10/14/2017
Start Date:	October 2013
End Date:	December 2016

Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)

An estimated 8 million individuals in America are affected by peripheral arterial disease
(PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD
can have a tremendous impact on patients' quality of life. It is also associated with high
rates of heart attacks and premature death. While there are a number of treatments, there
have been few previous studies that have prospectively examined treatment patterns for PAD or
sought to systematically identify opportunities to improve care. Most importantly, there have
been no rigorous studies examining the impact of the disease from patients' perspectives -
their symptoms, function and quality of life - as a function of different patient
characteristics and treatments. The PORTRAIT study (Phase II) will systematically document
the treatments and health status (symptom, function and quality of life) outcomes of 840 US
patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10
centers to address these gaps in knowledge. It will illuminate whether disparities in
treatment or health status outcomes exist as a function of patients' age, gender, race,
socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field
and identify critical gaps in the way PAD is currently managed, including potential
disparities in care, so that the quality of care can be improved.

Peripheral arterial disease (PAD) is a highly prevalent, but undertreated atherosclerotic
disease with a disproportionately poor cardiovascular prognosis, as compared with other
cardiovascular diseases. Cardiac events are, however, only one manifestation of PAD.
Patients' health status (symptoms, function, and quality of life) are critical outcomes from
patients' perspectives. To date, there have been no systematic prospective evaluations of
disease-specific health status outcomes in PAD and how these vary by treatment and patient
characteristics. The long-term goal of our work is to create an evidence-based multi-modal
PAD management program that can be individualized to each patient. Following our preparatory
work in Pilot PCORI grant 1 IP2 PI000753-01, the current proposal will develop a multi-center
observational registry called PORTRAIT (Patient-centered Outcomes Related to Treatment
Practices in peripheral Arterial disease: Investigating Trajectories). PORTRAIT will
prospectively define and relate patients' care to their health status outcomes as a function
of their treatment received at specialty clinics for new-onset, or exacerbations, of their
PAD. We hypothesize that there will be substantial variability in treatment patterns across
providers and by patient characteristics and that these will explain much of the variation in
patients' health status outcomes. Four hypothesis-driven specific aims will be tested; the
5th aim will result in a direct deliverable from this study:

Aim 1: We hypothesize strong associations between the severity of patients' health status and
the use of revascularization and that these will vary by age, gender, race, and
socio-economic status. This aim will examine variations in treatment by patient
characteristics as a foundation for identifying disparities in care.

Aim 2: We hypothesize that revascularization will be associated with more rapid, and larger,
improvements in health status as compared with non-invasive options, and that these benefits
will vary by age, gender, baseline health status, smoking cessation, minority race, and
depressive symptoms. The primary objective of PORTRAIT is to quantify patients' PAD-specific
health status outcomes overall, and as a function of treatment and patient characteristics.

Aim 3: We hypothesize that variations in performance measure adherence exist across
providers, with greater adherence to pharmacologic therapies for prevention, than exercise
treatments to improve function. We will compare real world PAD care against 4 PAD performance
measures to provide insights into the quality of PAD care.

Aim 4: We hypothesize that variations in pharmacologic and supervised exercise will be
associated with differences in health status outcomes and provide the evidence to suggest
that failure to prescribe these evidence-based treatments will result in lower health status
scores.

Aim 5: Use the new information to create educational tools to assist patients in selecting
treatments.

Inclusion Criteria:

- Age ≥ 21 years

- New or recent exacerbation of exertional leg symptoms

- Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure
≥20 mmHg

Exclusion Criteria:

- Non-compressible ankle-brachial index (≥1.30)

- Critical limb ischemia

- Lower-limb endovascular or surgical vascular procedure in past year

- Not speaking either English or Spanish

- Hearing impaired

- Unable to provide written informed consent

- Currently a prisoner

We found this trial at

sites

Rhode Island Hospital

593 Eddy Street
Providence, Rhode Island 02903

401-444-4000