Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) (PORTRAIT)
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|ClinicalTrials.gov Identifier: NCT01419080|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2011
Results First Posted : July 17, 2019
Last Update Posted : May 4, 2022
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|Condition or disease|
|Peripheral Arterial Disease Quality of Life Quality of Care|
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.
|Study Type :||Observational|
|Actual Enrollment :||797 participants|
|Official Title:||Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2023|
Peripheral Arterial Disease (PAD) patients
Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
- Peripheral Artery Disease (PAD) - Specific Health Status [ Time Frame: One Year ]Scores on a scale of 0-100 with higher scores representing better health status (0= worst health imaginable, 100= best health imaginable). Subscales are weighed in a standardized scoring algorithm (proprietary). Measures symptoms, symptom stability, and quality of life.
- All-cause Mortality [ Time Frame: One Year ]all-cause mortality
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Patients presenting to a PAD specialty clinic with new-onset exertional leg symptoms, or recent exacerbations of symptoms, will be screened for enrollment at 10 specialty PAD clinics. Trained study coordinators will have access to the outpatient clinic's schedule and be able to identify potentially eligible patients a priori so as to review medical records and identify potential patients. The diagnostic enrollment criterion includes a Doppler resting ankle-brachial index (ABI) ≤0.9026 or a significant drop in post-exercise ankle pressure of ≥20 mmHg. Patients will be asked to participate upon first visiting the PAD clinic, before treatment is started.
Study coordinators at each center will obtain informed consent and perform the baseline interview at the outpatient clinic.
- 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
- 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
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): NCT01419080
|United States, Connecticut|
|Bridgeport, Connecticut, United States, 06610|
|New Haven, Connecticut, United States, 06520|
|United States, Louisiana|
|Ochsner Health System|
|New Orleans, Louisiana, United States, 70121|
|United States, Michigan|
|Saint Joseph Mercy Hospital|
|Ann Arbor, Michigan, United States, 48106|
|United States, Missouri|
|Truman Medical Center|
|Kansas City, Missouri, United States, 64108|
|Saint Luke's Hospital of Kansas City|
|Kansas City, Missouri, United States, 64111|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Providence, Rhode Island, United States, 02904|
|Principal Investigator:||Kim Smolderen, PhD||Saint Luke's Hospital of Kansas City|
|Principal Investigator:||John A Spertus, MD, MPH||Saint Luke's Hospital of Kansas City|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Saint Luke's Health System|
|Other Study ID Numbers:||
|First Posted:||August 17, 2011 Key Record Dates|
|Results First Posted:||July 17, 2019|
|Last Update Posted:||May 4, 2022|
|Last Verified:||April 2022|
Peripheral Arterial Disease
Quality of Life
Quality of Care
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases