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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01419080
Acronym
PORTRAIT
Enrollment
797
Registered
2011-08-17
Start date
2013-10-31
Completion date
2016-12-31
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Quality of Care, Quality of Life

Keywords

Peripheral Arterial Disease, Quality of Life, Quality of Care

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Saint Luke's Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peripheral Artery Disease (PAD) - Specific Health StatusOne YearScores 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.

Secondary

MeasureTime frameDescription
All-cause MortalityOne Yearall-cause mortality

Countries

United States

Participant flow

Participants by arm

ArmCount
Peripheral Arterial Disease (PAD) Patients
Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
797
Total797

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath30
Overall StudyLost to Follow-up23
Overall StudyToo Ill3
Overall StudyWithdrawal by Subject75

Baseline characteristics

CharacteristicPeripheral Arterial Disease (PAD) Patients
Age, Continuous68.6 years
STANDARD_DEVIATION 9.7
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
782 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Peripheral Artery Questionnaire Summary Score Baseline46.8 units on a scale (0-100)
STANDARD_DEVIATION 22
Race/Ethnicity, Customized
Race
Black
183 Participants
Race/Ethnicity, Customized
Race
Other
37 Participants
Race/Ethnicity, Customized
Race
White
577 Participants
Region of Enrollment
United States
797 participants
Sex: Female, Male
Female
334 Participants
Sex: Female, Male
Male
463 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 797
serious
Total, serious adverse events
30 / 797

Outcome results

Primary

Peripheral Artery Disease (PAD) - Specific Health Status

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.

Time frame: One Year

ArmMeasureValue (MEAN)Dispersion
Received Invasive TreatmentPeripheral Artery Disease (PAD) - Specific Health Status70.7 units on a scale of 0-100Standard Deviation 25.4
Did Not Receive Invasive TreatmentPeripheral Artery Disease (PAD) - Specific Health Status66.9 units on a scale of 0-100Standard Deviation 25.1
Secondary

All-cause Mortality

all-cause mortality

Time frame: One Year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Received Invasive TreatmentAll-cause Mortality30 Participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026