NCT06330207

Brief Summary

The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Aug 2027

First Submitted

Initial submission to the registry

February 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 19, 2026

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

February 15, 2024

Last Update Submit

March 16, 2026

Conditions

Keywords

non-traumatic dental conditionsemergency departmentopioidantibiotic

Outcome Measures

Primary Outcomes (1)

  • Acceptability and feasibility

    Using qualitative methods, we will evaluate acceptability using the Theoretical Framework for Acceptability (TFA). Participants will complete a structured interview about acceptability at baseline and after 6 months of use, which should be sufficient time for providers to treat 5-10 patients for whom the tool is applicable. We pre-specify the criteria to define feasibility using criteria adapted from the NIH. Monthly during the trial, providers will answer feasibility surveys, using a web-based tool (i.e, RedCap) distributed via email. We will follow up with non-responders via text message, phone, or in-person. Providers will be offered a $5 gift card per survey as an incentive. To fully assess the impact of our intervention, we pre-specified a high retention rate as key to inform feasibility and effectiveness of future large-scale trials. We will consider successful implementation if \>50% of providers intend to continue using the NTDC CDST postpilot.

    at baseline, and up to 6 months

Secondary Outcomes (1)

  • Prescribing behavior

    at baseline, and up to 6 months

Other Outcomes (1)

  • Pilot trial outcomes

    up to 6 months post intervention

Study Arms (1)

Intervention

EXPERIMENTAL

ED providers who will test the clinical decision support tool when prescribing for patients with non traumatic dental conditions

Behavioral: Clinical decision support tool

Interventions

The intervention involves two strategies. The first strategy is education where at baseline participants will complete the one-hour online Smiles for Life oral health educational module on acute dental problems, which includes NTDC management. This module can be completed in multiple sessions. Providers will be asked to share the certificate of completion that is provided to them via the website by passing a post knowledge test. The second strategy is CDST. Providers who completed NTDC module certificate will pilot test the CDST which is an algorithm that walks the ED provider thru patient's signs and symptoms and identifies guideline-recommended treatments available in the ED.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED providers (physicians, nurse practitioners, physician assistants)
  • Working full-time in the ED

You may not qualify if:

  • Part-time ED providers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

ToothacheEmergencies

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Central Study Contacts

Tumader Khouja, BDS MPH PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 26, 2024

Study Start

January 15, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 19, 2026

Record last verified: 2025-04

Locations