Multi-Institutional IMPACT Validation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMPACT-G Module, IMPACT-N Module, IMPACT-O Module, IMPACT-J Module.
- Who it may be relevant to
- Registry conditions: Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)
Overview
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.
Interventions
- Other IMPACT-G Module
Administration of the general IMPACT survey module. - Other IMPACT-N Module
Administration of the IMPACT-N survey module. - Other IMPACT-O Module
Administration of the IMPACT-O survey module. - Other IMPACT-J Module
Administration of the IMPACT-J survey module. - Other 15D Control Survey
Administration of the 15D QOL control survey.
Primary outcome measures
- Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey [Time frame: When the initial survey is completed (within 12 months of the injury).]
Secondary outcome measures (4)
- Reliability: Covariance of each item in the IMPACT modules and subscales [Time frame: When the initial survey is completed (within 12 months of the injury).]
- Sensitivity to Change: Change in IMPACT scores over the treatment course. [Time frame: At the completion of the second survey.]
- Sensitivity to Change: Change in IMPACT scores over the treatment course. [Time frame: Baseline (at recruitement, Day 0) and at 4 weeks.]
- Minimally Clinically Important Difference (MCID) [Time frame: When the initial survey is completed (within 12 months of the injury).]
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
- Patients presenting to clinic for reasons not related to maxillofacial trauma.
- Patients with isolated fractures of the cranium or teeth.
- Patients who cannot read, write, and/or speak English.
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- University of California, Davis — Sacramento
- University of California, San Francisco — San Francisco
- University of Tennessee Health Science Center — Memphis
Publications
- 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. PMID 29550964
- 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. PMID 29650475
Identifiers
NCT: NCT06850857 · 24-09945-XP