The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale - PubMed (original) (raw)

doi: 10.1016/j.ijcha.2022.100971. eCollection 2022 Apr.

Carlos Mena-Hurtado 1, Mehdi H Shishehbor 2, John A Spertus 3, Sameer Nagpal 1, Trissa Babrowski 4, Matthew C Bunte 3, Amani Politano 5, Misty Humphries 6, Jayer Chung 7, Lee Kirksey 8, Olamide Alabi 9, Peter Soukas 10, Sahil Parikh 11, Rumi Faizer 12, Robert Fitridge 13, Jeremy Provance 1, Gaëlle Romain 1, Neil McMillan 13, Nancy Stone 3, Kate Scott 3, Christine Fuss 3, Christina M Pacheco 3, Kensey Gosch 3, Avis Harper-Brooks 1, Kim G Smolderen 1 14; SCOPE-CLI Academic Research Consortium

Affiliations

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale

Lindsey E Scierka et al. Int J Cardiol Heart Vasc. 2022.

Abstract

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI.

Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers.

Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American.

Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Keywords: Critical Limb Ischemia; Health Disparities; Patient-Reported Outcomes; Peripheral Artery Disease; Registries; Study Design.

© 2022 Published by Elsevier B.V.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1

Fig. 1

CLI Clinical Pathways for Identifying Eligible Patients for Enrollment in SCOPE-CLI. The clinical pathway for patients who will be enrolled in SCOPE-CLI is shown in Fig. 1. Patients presenting with symptoms of Rutherford Class 4–6 critical limb ischemia (CLI) will be enrolled in the outpatient setting including primary care, vascular surgery, podiatry, and interventional cardiology clinical as well as the inpatient setting either during a CLI-related or non-CLI related admission. Patients will undergo diagnostics and clinical evaluation per the standard of care. Based on the standard of care of the treating team, patients either will or will not undergo intervention. Intervention status does not determine eligibility into the study.

Fig. 2

Fig. 2

Map of Sites Participating in SCOPE-CLI in the United States and Australia. The eleven sites enrolling patients in SCOPE-CLI are shown on the map in Fig. 2. These include various academic institutions across the United States and one site in Australia.

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