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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help patients feel more informed and less uncertain when leaving the emergency room. It aims to improve communication about unclear diagnoses using a tool called Targeted EHR-based Communication of Diagnostic Uncertainty (TECU), which alerts doctors to discuss any uncertainty with patients. The trial includes two groups: one receiving standard care and another where doctors use the new communication strategy. It seeks participants who have received a symptom-based diagnosis and are leaving the emergency department. This unphased trial offers a unique opportunity to contribute to enhancing patient-doctor communication in emergency settings.

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 prior data suggests that the TECU strategy is safe for improving care transitions?

Research has shown that the Targeted EHR-based Communication about Uncertainty (TECU) strategy is designed to assist patients when they leave the emergency department (ED) with some uncertainty about their diagnosis. This tool facilitates clear communication between doctors and patients regarding this uncertainty.

Specific safety data is not available because TECU is neither a medication nor a medical device. Instead, it utilizes electronic health records to enhance communication. The goal is to ensure patients have a better understanding of their situation upon discharge. Since it does not involve medication or procedures, it lacks the risks, such as side effects, typically associated with medical treatments. Instead, it focuses on improving conversations between patients and doctors, which does not pose a direct safety risk to patients.

Overall, TECU aims to ensure patients feel more informed and less uncertain when leaving the ED, without introducing any new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TECU (Targeted EHR-based Communication of Diagnostic Uncertainty) trial because it aims to enhance communication between emergency department clinicians and patients regarding uncertain diagnoses. Unlike standard care, which often lacks structured communication processes for diagnostic uncertainty, TECU uses an innovative electronic health record (EHR) system. This system notifies clinicians to discuss uncertainty with patients and automatically provides helpful tools, like patient handouts and clinician-facing checklists, to guide these conversations. The hope is that this approach will improve patient understanding and satisfaction, leading to better health outcomes.

What evidence suggests that the TECU strategy is effective for improving care transitions from the ED to home?

Research has shown that the Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) assists patients who leave the emergency department (ED) without a clear diagnosis. Studies have found that about 37% of ED patients are discharged without knowing exactly what is wrong, which can be confusing and worrying. In this trial, participants in the Post-TECU Implementation arm will experience the TECU system, which uses electronic health records to help doctors explain this uncertainty better to patients. Early results suggest that TECU can reduce patients' confusion and lower the number of times they need to return to the ED. This method includes a checklist for doctors to ensure they discuss important information when a patient is discharged. The goal is to make going home from the ED safer and less stressful for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Kristin L Rising, MD, MS

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40204252/

Targeted EHR-based communication of diagnostic ... Background: At least 37 % emergency department (ED) patients are discharged without a definitive diagnosis, resulting in diagnostic uncertainty.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001041

Targeted EHR-based communication of diagnostic ... This study aims to enhance transitions for patients leaving the ED with diagnostic uncertainty through an electronic health record (EHR)-based strategy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06638021

Targeted EHR-based Communication of Diagnostic ... The aims of this study are to test the preliminary effectiveness of TECU compared to standard of care in reducing patient uncertainty and return ED visits, and ...

4. reporter.nih.gov reporter.nih.gov/project-details/10932370

RePORT RePORTER - National Institutes of Health (NIH) | Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial ... Data on efficacy and implementation ...

5. profiles.wustl.edu profiles.wustl.edu/en/publications/targeted-ehr-based-communication-of-diagnostic-uncertainty-tecu-i

Targeted EHR-based communication of diagnostic ... The pre-post trial seeks to test the intervention's effectiveness in reducing patient uncertainty and return ED visits compared to standard of care with 300 ...