TECU for Diagnostic Uncertainty

(TECU Trial)

Overseen By Amanda MB Doty, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Under 18, Non-English, Unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the clinical trial is to evaluate the preliminary effectiveness and the implementation feasibility of the Targeted EHR-based Communication about Uncertainty (TECU) strategy in improving the quality of care transitions from the emergency department (ED) to home. The overall specific aims related to the trial are to test the preliminary effectiveness of TECU compared to standard of care in reducing patient uncertainty and return ED visits and evaluate the adoption of TECU, exploring patient and clinician barriers and facilitators to TECU implementation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)?

The research highlights that communication of diagnostic uncertainty is often not effectively conveyed to patients, and improvements in electronic health records (EHRs) could help. While specific data on TECU's effectiveness is not provided, studies suggest that better EHR design and clinician training can improve communication, which may support TECU's goals. ^{1 2 3 4 5}

How is the TECU treatment different from other treatments for diagnostic uncertainty?

TECU is unique because it focuses on improving communication about diagnostic uncertainty through targeted electronic health record (EHR) interventions, which is not a standard approach in current medical practice. Unlike traditional treatments that may focus on diagnosis or symptom management, TECU aims to enhance shared decision-making by addressing the communication gap between healthcare providers and patients regarding uncertainty in diagnoses. ^{1 6 7 8 9}

Research Team

Kristin L Rising, MD, MS

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for patients experiencing unclear diagnoses in the emergency department (ED). It aims to see if a new communication method, using electronic health records (EHR), helps with their care after they leave the ED. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

I can attend follow-up checks 2 and 30 days after treatment.

English language speaking

Planned for discharge from the ED during the enrollment visit

Exclusion Criteria

I am currently admitted to a hospital.

I am under 18 years old.

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-TECU Implementation

No intervention administered; baseline data collection for comparison

4 weeks

Post-TECU Implementation

Implementation of TECU strategy with clinician notifications and patient handouts

4 weeks

Follow-up

Participants are monitored for healthcare utilization and quality of care transitions

30 days

Treatment Details

Interventions

• Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)

Trial Overview The study tests a strategy called TECU that uses EHRs to communicate uncertainties about patient diagnoses from the ED. Its effectiveness will be compared against standard practices, focusing on reducing patient uncertainty and preventing return visits to the ED.

Participant Groups

Group I: Post-TECU Implementation Experimental Treatment 1 Intervention

When an ED clinician enters an uncertain diagnosis for a patient being discharged, the TECU BPA will notify the clinician to counsel the patient about uncertainty while additionally triggering automated 1) insertion and printing of the patient handout and 2) provision of a hyperlink for the clinician-facing checklist to guide the discharge conversation.

Group II: Pre-TECU Implementation Active Control 1 Intervention

No intervention administered.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Electronic health record reviews to measure diagnostic uncertainty in primary care. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Accuracy and Completeness of Clinical Coding Using ICD-10 for Ambulatory Visits. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Communicating diagnostic uncertainty in the acute and emergency medical setting: A systematic review and ethical analysis of the empirical literature. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Brief report: Improving communication of diagnostic uncertainty to families of hospitalized children. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Electronic health records, communication, and data sharing: challenges and opportunities for improving the diagnostic process. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Communicating Uncertainty: a Narrative Review and Framework for Future Research. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

I Don't Have a Diagnosis for You: Preparing Medical Students to Communicate Diagnostic Uncertainty in the Emergency Department. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Communicating Diagnostic Uncertainty at Emergency Department Discharge: A Simulation-Based Mastery Learning Randomized Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Simulation-based mastery learning compared to standard education for discussing diagnostic uncertainty with patients in the emergency department: a randomized controlled trial. [2020]