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

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.

Pilot survey of prescription opioid use patterns and engagement with harm-reduction strategies in emergency department patients.

Background: The United States is experiencing an opioid epidemic. The aim of this pilot study was to describe patterns of prescription opioid medication (POM) use, examine factors associated with opioid misuse and overdose, and assess knowledge of take-home naloxone, and other harm-reduction strategies as well as participation in medications for opioid use disorder (MOUD) among emergency department (ED) patients that have been prescribed opioid medications. Methods: This was a pilot survey of a convenience sample of adult ED patients with a past opioid prescription at one urban tertiary care hospital. The survey asked participants about patterns of opioid consumption, risk factors associated with opioid misuse, and knowledge of harm-reduction strategies. The survey tool consisted of mixed open- and closed-ended questions. Reported daily POM consumption was converted to milligram morphine equivalents (MME). Responses to survey questions were compared with daily MME in order to generate hypotheses for future research. Results: 50 individuals completed a survey. Of these, 56% reported taking opioids daily, and 24% reported greater than 100 MME daily opioid consumption. Many subjects reported history of psychiatric illness (34%) and previous substance abuse treatment (24%). The majority of patients (66%) were not aware of take-home naloxone programs to treat opioid overdose. Conclusions: In this pilot survey of ED patients with a pain-related chief complaint, many respondents reported risk factors for opioid misuse, and the majority of participants were unaware of the existence of important harm-reduction strategies, such as take-home naloxone programs, even among those with the highest daily POM use.