Multi-Institutional IMPACT Validation

Launched by UNIVERSITY OF TENNESSEE · Feb 24, 2025

Keywords

ClinConnect Summary

This is an observational study to see if a new patient-reported outcome tool called IMPACT can reliably measure how facial injuries affect a person’s everyday life. Researchers will compare IMPACT scores with a well-established quality-of-life survey (the 15D) to see if IMPACT is valid and consistent for different facial injuries (like nose, orbital area, or jaw fractures). It’s not testing a treatment; rather, it’s testing a questionnaire to better understand patients’ experiences after facial trauma.

Who can join? Adults 18 and older who have had facial trauma (fractures of facial bones or soft tissue injuries) within the past year and are being seen in clinics such as ear, nose, and throat; oral and maxillofacial surgery; plastic surgery; or eye clinics. People with only skull or teeth fractures, those who cannot read/write/speak English, or those who cannot give informed consent are not eligible. If invited to participate, you would complete IMPACT surveys (general module plus any injury-specific module) and the 15D quality-of-life survey. You would do these at baseline and at follow-up visits (often within a month and then within a year). The study is currently enrolling by invitation and aims to include up to about 500 participants across several sites; results are not available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of maxillofacial trauma (fracture of any facial bone\[s\] and/or soft tissue injury) within 12 months of recruitment date.
• Exclusion Criteria:
• • 1. Patients presenting to clinic for reasons not related to maxillofacial trauma.
• • 2. Patients with isolated fractures of the cranium or teeth.
• • 3. Patients who cannot read, write, and/or speak English.
• • 4. Patients who are unable to provide informed consent for themselves (including those who are under 18 years old, incapacitated, intoxicated, or cognitively impaired with a legal guardian)