An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergency Department Visit; Odontalgia
• Intervention / Treatment: Behavioral: Clinical decision support tool

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Part-time ED providers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: Clinical decision support tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescribing behavior	For each participant, we will collect baseline antibiotic and opioid prescribing rates (per ED visit) for NTDC 6 months prior to the intervention from the EHR using the UPMC data analytics tool. All ED prescriptions in our system are created electronically, allowing precise capture of actual provider behavior. We will compare opioid and antibiotic prescribing for NTDC by providers before and after the intervention. To control for secular changes in prescribing, we will compare prescribing by participants during the same 6 months to prescribing by UPMC peers who did not receive the intervention.	at baseline, and up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot trial outcomes	We will develop good clinical practices to enhance the rigor and reproducibility of the research. This includes development of documentation, informed consent procedures, data collection tools, regulatory reporting, and monitoring procedures. In this pilot, we will evaluate possible outcome measures to quantify changes in ED provider NTDC management behavior. Qualitative and quantitative data generated will inform any necessary refinements to the intervention. This will provide a platform for larger evaluation to assess the effectiveness of our intervention for improving NTDC management in the ED.	up to 6 months post intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: opioid; antibiotic; emergency department; non-traumatic dental conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Emergencies; Toothache
• Other Study ID Numbers: IRB202301471; K99DE031723 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No