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Published on: September 22, 2020
The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry
Lindsey E Scierka1, Carlos Mena-Hurtado1, Mehdi H Shishehbor2
1Yale University, Department of Internal Medicine, Vascular Medicine Outcomes Program (VAMOS), New Haven, CT, United States.
Insights
The SCOPE-CLI study co-designs care for critical limb ischemia (CLI) patients, capturing their experiences and preferences to improve outcomes. This research aims to address gaps in CLI care quality.
Area of Science:
- Vascular Medicine
- Patient-Centered Outcomes Research
- Peripheral Artery Disease
Background:
- Critical limb ischemia (CLI) is a severe form of peripheral artery disease with high amputation and mortality rates.
- Patient perspectives on care processes, preferences, and outcomes in CLI are poorly understood.
- The SCOPE-CLI study was co-designed with patients to address these knowledge gaps.
Purpose of the Study:
- To holistically document patient characteristics, treatment preferences, and patterns of care for individuals with CLI.
- To capture patient-centered outcomes from the perspective of those affected by CLI.
- To identify and address disparities in the quality of care and outcomes for CLI patients.
Main Methods:
- An 11-center prospective observational registry enrolling 816 patients with CLI in the US and Australia.
- Patients are interviewed and followed for 12 months, with vital status tracked for 5 years.
- Data collection includes psychosocial factors, health status, hospitalizations, interventions, and patient-reported outcomes.
Main Results:
- Pilot data from 3 centers enrolled 70 patients.
- The initial cohort had a mean age of 68.4 years, with 31.4% females and 20.0% African Americans.
- Enrollment and data collection are ongoing.
Conclusions:
- The SCOPE-CLI study, co-designed with patients, offers a unique approach to understanding the CLI population.
- Findings will provide crucial insights into care experiences, treatment preferences, and health status outcomes.
- This research is vital for improving the quality of care and outcomes for this vulnerable patient group.
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.
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