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

Odontalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330207
• Other study ID #: IRB202301471
• Secondary ID: K99DE031723
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2025
• Est. completion date: August 1, 2027

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ED providers (physicians, nurse practitioners, physician assistants)

• Working full-time in the ED

Exclusion Criteria:

• Part-time ED providers

Related Conditions & MeSH terms

• Emergencies
• Emergency Department Visit
• Odontalgia
• Toothache

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Dental and Craniofacial Research (NIDCR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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