Clinical trial NCT06850857: Multi-Institutional IMPACT Validation
Official title: Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Facial Injuries
Mandible Fracture
Le Fort
Zygomaticomaxillary Complex Fracture
Nasal Fracture
Orbital Fractures
Zygoma Fracture
Orbital Floor Fracture
Facial Laceration
Keywords: Facial Trauma
Maxillofacial Trauma
Patient-Reported Outcomes
Quality of Life
IMPACT
Mandible Fracture
Midface Fracture
Orbital Fracture
Nasal Fracture
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California, Davis
name: University of Maryland
name: Vanderbilt University
First posted: 2025-02-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified from the population of patients presenting to clinics where facial trauma is managed, including otolaryngology, oral and maxillofacial surgery, plastic surgery, and/or ophthalmology clinic(s).

Brief summary: The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The primary question is:

Are the IMPACT modules valid and reliable measures to study quality-of-life (QOL) in patients with maxillofacial trauma?

Patients presenting for routine clinic follow-up for maxillofacial trauma will be invited to complete the IMPACT in addition to the 15 Dimension (15D) QOL survey as a control.

Detailed description: Background: Maxillofacial trauma literature is dominated by objective and physician-rated outcomes, leaving a paucity of patient-reported outcome (PRO) research. In fact, no PRO measure (PROM) has ever been validated in this population, posing a tremendous barrier to our understanding of the patient experience. This project will overcome this barrier by validating a novel PROM designed by our research group: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The IMPACT is the first PROM designed for maxillofacial trauma, providing novel insight into the patient experience. In its current form, it is a 4-module survey instrument: one general module for all patients (IMPACT-G) and 3 modules specific to fractures of the nasal (IMPACT-N), orbital (IMPACT-O), and/or jaw (IMPACT-J) regions. Each module takes 2-5 minutes to complete for a total of 2-20 minutes, depending on the injury.

Objectives: This study will be a multi-institutional field test to determine the validity and reliability of using the IMPACT for measuring QOL in patients suffering maxillofacial trauma. The hypothesis is that each IMPACT module and subscale will significantly and at least moderately correlate with the 15D, an established general QOL survey instrument.

Methods: Patients with maxillofacial trauma presenting for routine follow-up within one year from their injury will be invited to complete the IMPACT and the 15D survey. Patients who completed an initial survey and return within one month will be invited to complete a second follow-up survey. The scores be tested for validity and reliability using multivariable linear regression, Pearson's r, Cronbach alpha, and test-retest reliability. The sensitivity to change and minimally clinically important difference (MCID) will also be calculated.

Impact: Validation of the first PROM for maxillofacial trauma is anticipated to have a significant and lasting impact in the field of maxillofacial trauma. This will allow researchers and clinicians to better understand the patient experience and make management recommendations accordingly. Integrating the IMPACT into future studies may revolutionize the field by providing novel evidence for controversial topics such as maxillomandibular fixation techniques, surgical approaches, adjunctive therapies, and more.

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)

Primary outcomes:
measure: Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey
timeFrame: When the initial survey is completed (within 12 months of the injury).
Secondary outcomes:
measure: Reliability: Covariance of each item in the IMPACT modules and subscales
timeFrame: When the initial survey is completed (within 12 months of the injury).
measure: Sensitivity to Change: Change in IMPACT scores over the treatment course.
timeFrame: At the completion of the second survey.
measure: Sensitivity to Change: Change in IMPACT scores over the treatment course.
timeFrame: Baseline (at recruitement, Day 0) and at 4 weeks.
measure: Minimally Clinically Important Difference (MCID)
timeFrame: When the initial survey is completed (within 12 months of the injury).
Other outcomes:
measure: Independent predictors of IMPACT scores
timeFrame: When the initial survey is completed (within 12 months of the injury).
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
citation: Terwee CB, Prinsen CAC, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, Bouter LM, de Vet HCW, Mokkink LB. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. 2018 May;27(5):1159-1170. doi: 10.1007/s11136-018-1829-0. Epub 2018 Mar 17.
citation: Ologunde R, McLeod NMH. Use of patient-reported outcome measures in oral and maxillofacial trauma surgery: a review. Br J Oral Maxillofac Surg. 2018 Jun;56(5):371-379. doi: 10.1016/j.bjoms.2018.03.010. Epub 2018 Apr 9.