Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: an International Trajectory (PORTRAIT Registry)

This study is currently recruiting participants.
Verified June 2013 by Saint Luke's Health System
Sponsor:
Collaborators:
W. L. Gore and Associates
Nationaal Instituut voor Wetenschappelijk Onderzoek Nederland - VENI grant
Information provided by (Responsible Party):
Kim Smolderen, Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT01419080
First received: August 16, 2011
Last updated: June 25, 2013
Last verified: June 2013
  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 and their families. 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 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 will systematically document the treatments and outcomes of 240 patients from 2 centers to address these gaps in knowledge. It will illuminate whether disparities in treatment or outcomes exist, as a function of patients' gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field and identify critical gaps in the way PAD is currently managed to 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: an International Trajectory (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: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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 associated with a disproportionately poor prognosis, as compared with other atherosclerotic diseases. While poor risk factor treatment may partially explain PAD patients' poor clinical outcomes, cardiac events are only one manifestation of the disease. For PAD patients, their health status (symptoms, function, and quality of life) are critical outcomes of the disease. To date, however, there have been no systematic evaluations of disease-specific health status outcomes in PAD and how these vary by patient or treatment characteristics. These gaps in knowledge exist despite guidelines stating that the primary goals of PAD treatment should be symptom relief and quality of life improvement. Explicit hypotheses underlying PORTRAIT are that: PAD care is organized in a fragmented way (multiple specialists performing a myriad of treatments), is associated with a wide variation in initial treatment strategies. These variations will be reflected in different degrees to which providers adhere to guideline-recommended cardiovascular risk management strategies. It is also expected that racial, gender, and age disparities in treat-ment patterns and outcomes (patient-centered outcomes and prognosis) exist.

A total of 2 PAD specialty clinics (vascular surgery and interventional cardiology) will consecutively enroll 240 patients with new or recently exacerbated PAD symptoms. Treatment and disease-specific health status information at baseline and at 3, 6, and 12 months will be collected; and 1-year adjudicated follow-up on cardiovascular events will be organized to address the following specific aims:

Aim 1: Examine patient characteristics and variations in treatment strategies for PAD patients initially present-ing to a PAD clinic for care with new or an exacerbation of PAD symptoms Aim 2: Compare real world use of PAD care delivery strategies with current PAD performance measures Aim 3: Quantify the variability in patients' 1-year PAD-specific health status outcomes overall and as a func-tion of treatment and patient characteristics Aim 4: Evaluate 1-year rates of cardiovascular events; overall and by treatment and patient characteristics Virtually all of the aims are innovative, as prior research has been limited to procedural registries, smaller, generic health status studies, and heterogeneous cohorts, which partly explain why patients' health status have not yet become important standards in guiding PAD treatment. Accomplishing the proposed aims will be crucial to achieving our overarching goal of creating a multi-modal PAD management program; one that uses novel personalized and system-oriented approaches to increase the use of evidence-based guidelines and to optimize patients' outcomes. PORTRAIT is the first step towards achieving this goal and will enrich the evidence-base with real-world data so that concrete targets for future innovations in PAD care can be developed.

  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 11 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.5 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
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
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kristi Bova       kbova@ymail.com   
Principal Investigator: Carlos Mena, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02199
Contact: Beau Hawkins, MD       BHAWKINS@PARTNERS.org   
Principal Investigator: Kenneth Rosenfield, M.D.         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Felicia Formosa    734-715-5396      
Contact: Susan Winter    (734) 715-5396      
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         
Sponsors and Collaborators
Saint Luke's Health System
W. L. Gore and Associates
Nationaal Instituut voor Wetenschappelijk Onderzoek Nederland - VENI grant
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: June 25, 2013
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
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014