Targeted EHR-based Communication of Diagnostic Uncertainty in the ED

Not Applicable

Not yet recruiting

• Conditions: Diagnostic Uncertainty

• Registration Number: NCT06638021
• Lead Sponsor: Thomas Jefferson University

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 effectivene...

Detailed Description

At least 37% of patients treated in the emergency department (ED) are discharged without a definitive diagnosis, thus leaving the encounter with diagnostic uncertainty. Transitions of care are high-risk periods for patient safety, especially when patients are discharged with diagnostic uncertainty, and thus are still within the diagnostic process. Effective ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16
• Study Start: 2024-11-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Uncertainty Scale (U-Scale)	enrollment	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 ra...

Secondary Outcome Measures

Name	Time	Method
The Care Transition Measure (CTM)-3	2 days post enrollment	The Care Transition Measure (CTM)-3 , an abbreviated form of the Care Transition Measure, will be used to assess the quality of the care transition. The CTM-3 has been highlighted as a useful measure to capture the quality of ED-to-home care transitions to aid quality improvement. Scores can range from 0-100; the score reflects the overall quality of the car...
Transitions During Uncertainty (TDU) questionnaire	2 days post enrollment	The TDU will be used to assess the quality of the care transition. The TDU was designed to assess care transitions upon ED discharge, to measure both the quality of existing care transition practices and the impact of care transition interventions.
Normalisation MeAsure Development questionnaire (NoMAD)	At clinician enrollment	The NoMAD assesses staff perceptions of factors relevant to embedding the TECU intervention that change their work practices. The investigators will explore early implementation outcomes using the NoMAD with clinicians exposed to the TECU intervention.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States