Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT06638021

Conditions

Diagnostic Uncertainty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)

Study Details

Brief summary:

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.

Conditions

Diagnostic Uncertainty

Study ID

NCT06638021

Start date

Nov 5, 2024

Status verified date

Apr, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patient Inclusion Criteria:

  • age 18 years or older
  • English language speaking
  • assigned a symptom-based diagnosis in the EHR clinical impression
  • planned for discharge from the ED during the enrollment visit
  • able to complete follow up assessments in 2 and 30 days
  • TECU best practice advisory (BPA) electronic health record alert activates during their discharge process

Patient Exclusion Criteria:

  • under the age of 18 years
  • non-English speaking
  • clinically unstable, psychologically impaired or intoxicated, or otherwise unable to provide informed consent as judged by research staff member
  • admitted to hospital
  • unable to complete follow up in 2 and 30 days
  • previously enrolled in this study (during a prior ED visit)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Pre-TECU Implementation

No intervention administered.

experimental: Post-TECU Implementation

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.

Interventions

Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)

The Targeted EHR-based Communication about Uncertainty (TECU) strategy will be activated in the electronic health record (Epic) every time an ED clinician enters an uncertain diagnosis for a patient being discharged, and 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.

Primary outcome measure

  • Uncertainty Scale (U-Scale) [ Time Frame: enrollment ]

Central Contacts and Locations

Central contacts

Kristin L Rising, MD, MS

2673031359kristin.rising@jefferson.edu

Amanda MB Doty, MS

2155034619amanda.doty@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Amanda MB Doty, MS

2155034619amanda.doty@jefferson.edu

Philip Watts

215-520-7595Phillip.Watts@jefferson.edu

Principal Investigator:

Kristin L Rising, MD, MS

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Keywords

  • Patient uncertainty
  • Symptom-based diagnosis
  • ED Discharge Communication
  • Diagnostic Uncertainty
  • Best practice advisory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-04-16.