Targeted EHR-based Communication of Diagnostic Uncertainty in the ED

NCT06638021 | Recruiting

• 1 other identifier: 1R18HS029791-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Uncertainty Scale (U-Scale)

  The Uncertainty Scale (U-Scale) is a 30-item scale designed to measure patient-level uncertainty related to acute symptoms independent of underlying disease. The scale uses a 5-point Likert-style response format, asking respondents to indicate agreement with each statement from "strongly disagree" (1) to "strongly agree" (5) and leading to a nominal score range of 30-150. Higher scores indicate greater uncertainty.

  enrollment

Secondary Outcomes (3)

• The Care Transition Measure (CTM)-3

  2 days post enrollment

• Transitions During Uncertainty (TDU) questionnaire

  2 days post enrollment

• Normalisation MeAsure Development questionnaire (NoMAD)

  At clinician enrollment

Other Outcomes (15)

• Return emergency department (ED) visits

  9 days post enrollment

• Return emergency department (ED) visits

  30 days post enrollment

• Composite healthcare utilization

  30 days post enrollment

Study Arms (2)

Pre-TECU Implementation

NO INTERVENTION

No intervention administered.

Post-TECU Implementation

EXPERIMENTAL

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.

Behavioral: Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)

Interventions

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

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.

Also known as: TECU

Post-TECU Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Northwestern University: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

• McCarthy DM, Malone S, Papanagnou D, Leiby BE, Doty AMB, Watts P, Yadav R, Pugliese JK, Woodworth J, Camacho TE, Kean E, Rising KL. Targeted EHR-based communication of diagnostic uncertainty (TECU) in the emergency department: Protocol for an effectiveness implementation trial. Contemp Clin Trials. 2025 Jun;153:107910. doi: 10.1016/j.cct.2025.107910. Epub 2025 Apr 7.

  PMID: 40204252 DERIVED

Study Officials

• Kristin L Rising, MD, MS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin L Rising, MD, MS

CONTACT

2673031359; kristin.rising@jefferson.edu

Amanda MB Doty, MS

CONTACT

2155034619; amanda.doty@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre-post hybrid type 1 effectiveness implementation design

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: October 15, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)