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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01419080
Other study ID # 11-533
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2013
Est. completion date December 2024

Study information

Verified date June 2023
Source Saint Luke's Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 797
Est. completion date December 2024
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Bridgeport Hospital Bridgeport Connecticut
United States Cleveland Clinic Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Truman Medical Center Kansas City Missouri
United States Yale University New Haven Connecticut
United States Ochsner Health System New Orleans Louisiana
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Saint Luke's Health System Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Rother J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206. doi: 10.1001/jama.297.11.1197. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. One Year
Secondary All-cause Mortality all-cause mortality One Year
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