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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Saint Luke's Health System
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
Kim Smolderen, Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT01419080
First received: August 16, 2011
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

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.


Condition
Peripheral Arterial Disease
Quality of Life
Quality of Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • Peripheral Artery Disease (PAD) - Specific health status [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular events [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Peripheral Arterial Disease (PAD) patients
Patients with new onset or exacerbation of peripheral artery (PA) symptoms.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419080

Contacts
Contact: Kim Smolderen, PhD 816-932-2507 k.g.e.smolderen@gmail.com
Contact: Kate Scott, BA 816-932-6090 kscott2@saint-lukes.org

Locations
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Jessica LeBlanc       Jessica.Leblanc@bpthosp.org   
Principal Investigator: Ed Tuohy, MD         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jackie Gamberdella       jacqueline.gamberdella@yale.edu   
Principal Investigator: Carlos Mena, MD         
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jessica Henry       jgelpi@ochsner.org   
Principal Investigator: Christopher White, MD         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Felicia Formosa    734-715-5396      
Contact: Janet Obear    (734) 712-5193      
Principal Investigator: Herbert Aronow, MD         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Kim Smolderen, PhD    816-932-5708    k.g.e.smolderen@gmail.com   
Contact: Kate Scott, BA    816-932-6090    kscott2@saint-lukes.org   
Principal Investigator: Kim Smolderen, PhD         
Principal Investigator: John A Spertus, MD, MPH         
Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Contact: Kim Dyer       kim.dyer@tmcmed.org   
Principal Investigator: Mark Friedell, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Hillary Hood       hillary.hood@duke.edu   
Contact: Latasha Oxendine       Latasha.oxendine@duke.edu   
Principal Investigator: Manesh Patel, M.D.         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jackie McCluskey       mcclusj@ccf.org   
Principal Investigator: Mehdi Shishehbor, DO         
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02904
Contact: Jassira Gomes       jgomes8@lifespan.org   
Principal Investigator: Peter Soukas, MD         
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kelley Franchetti       kfranchetti@lifespan.org   
Principal Investigator: Dawn Abbott, MD         
Sponsors and Collaborators
Saint Luke's Health System
Patient Centered Outcome Research Institute
Investigators
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
  More Information

Publications:
Responsible Party: Kim Smolderen, Research Scientist, Outcomes Research, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT01419080     History of Changes
Other Study ID Numbers: 11-533
Study First Received: August 16, 2011
Last Updated: April 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:
Peripheral Arterial Disease
Quality of Life
Quality of Care

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2015