Multi-Institutional IMPACT Validation

June 13, 2025 updated by: University of Tennessee

Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nasal Fractures (IMPACT-N)
This group includes patients with fracture patterns that involve the nasal bones, nasal cavity, and/or sinuses, including: isolated nasal bone fractures, nasoorbitoethmoidal fractures, maxillary sinus fractures, Le Fort I-III fractures, and frontal sinus fractures.
Other: 15D Control Survey
Administration of the 15D QOL control survey.
Other: IMPACT-G Module
Administration of the general IMPACT survey module.
Other: IMPACT-N Module
Administration of the IMPACT-N survey module.
Orbital Fractures (IMPACT-O)
This group includes patients with fracture patterns that involve the orbital walls or rim, including: isolated orbital fractures, zygomaticomaxillary complex fractures, nasoorbitoethmoidal fractures, and Le Fort II-III fractures.
Other: 15D Control Survey
Administration of the 15D QOL control survey.
Other: IMPACT-G Module
Administration of the general IMPACT survey module.
Other: IMPACT-O Module
Administration of the IMPACT-O survey module.
Jaw Fractures (IMPACT-J)
This group includes patients with fracture patterns that involve the upper or lower jaw, including: mandible fractures, dentoalveolar fractures, and Le Fort I-III fractures. Zygomatic arch fractures will also be included given potential impairment of the jaw.
Other: 15D Control Survey
Administration of the 15D QOL control survey.
Other: IMPACT-G Module
Administration of the general IMPACT survey module.
Other: IMPACT-J Module
Administration of the IMPACT-J survey module.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Criterion validity will primarily be determined by calculating the correlation between each of the IMPACT module total scores and the 15D QOL control survey via Pearson's r, controlling for independent variables that influence survey scores.
When the initial survey is completed (within 12 months of the injury).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
The reliability of each module and subscale will be measured via Cronbach alpha's measurement of internal consistency,
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.
The sensitivity to change will be evaluated by comparing consecutive IMPACT module and subscale scores for patients who completed the survey two times.
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.
Follow-up IMPACT scores will be collected 4 weeks from the baseline recruitment and analyzed for improvement from the baseline scores.
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).
The MCID will be calculated for each IMPACT module and subscale via an anchor-based approach, using a single global question designed to comprehensively assess how the patient feels regarding their facial injury.
When the initial survey is completed (within 12 months of the injury).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent predictors of IMPACT scores
Time Frame: When the initial survey is completed (within 12 months of the injury).
Independent variables that influence IMPACT scores for each module and subscale will be evaluated, including: demographics (age, sex, race, ethnicity), socioeconomic factors (social-vulnerability index, type of insurance), severity of trauma (Comprehensive facial injury [CFI] and Facial Injury Severity Score [score]), primary management (observation, closed treatment, and/or maxillomandibular fixation), multisystem trauma, and level of care (discharged from ED, admitted to floor / stepdown, or admitted to ICU).
When the initial survey is completed (within 12 months of the injury).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

University of Maryland
University of California, Davis
University of California, San Francisco
Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-09945-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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