Targeted EHR-based Communication of Diagnostic Uncertainty in the ED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted EHR-based Communication of Diagnostic Uncertainty (TECU).
- Who it may be relevant to
- Registry conditions: Diagnostic Uncertainty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial
Overview
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.
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 communication between clinicians and patients is essential to improve the quality of these care transitions. In prior AHRQ-funded research, the investigators developed several tools to support high quality discharge in the setting of diagnostic uncertainty, including a communication checklist, a training program for physicians in uncertainty communication, and a patient-facing 1-page information sheet about being discharged with uncertainty.
The investigators now propose to leverage the electronic health record (EHR) to implement a multifaceted strategy to facilitate higher quality discharge transitions for patients discharged from the ED with diagnostic uncertainty. Our Targeted EHR-based Communication about Uncertainty (TECU) strategy will be activated 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) an EHR-embedded link to the clinician-facing checklist to guide the discharge conversation.
The investigators will conduct a pre-post trial with a hybrid type 1 effectiveness implementation design with the goals of: 1) Testing the preliminary effectiveness of TECU compared to standard of care in reducing patient uncertainty and return ED visits and 2) Evaluating the adoption of TECU and exploring patient and clinician barriers and facilitators to TECU implementation. This project has potential to significantly impact the quality and safety of care transitions for the one-third of patients leaving the emergency department with diagnostic uncertainty.
The TJU informatics team has built a strategy within Epic to leverage the electronic health record (EHR) to implement a multifaceted strategy to facilitate safer and higher quality discharge transitions for patients discharged from the ED with diagnostic uncertainty. This strategy - the Targeted EHR-based Communication about Uncertainty (TECU) - integrates use of an Uncertainty Communication Checklist (UCC) and an Uncertainty Discharge Document (UDD) into routine Emergency Department discharge workflows. The UCC is a checklist that guides a conversational approach, to aid clinicians in addressing topics of chief concern for patients discharged with diagnostic uncertainty. The UDD is a 1-page patient-centered, health literacy appropriate discharge document that explains the concept of diagnostic uncertainty to patients. Implementing the TECU within the EHR will alert clinicians in real-time to discuss uncertainty and to standardize the routine delivery of information about uncertainty, thereby minimizing variation and reducing bias. The investigators will conduct a hybrid type 1 design with a pre-post trial of the TECU at an urban academic ED to assess preliminary efficacy of the TECU in improving patient transitions of care home from the ED and implementation of the TECU including clinician uptake as well as barriers and facilitators to implementation.
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 evaluate the adoption of TECU and explore patient and clinician barriers and facilitators to TECU implementation.
Interventions
- Behavioral 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 measures
- Uncertainty Scale (U-Scale) [Time frame: enrollment]
Secondary outcome measures (3)
- The Care Transition Measure (CTM)-3 [Time frame: 2 days post enrollment]
- Transitions During Uncertainty (TDU) questionnaire [Time frame: 2 days post enrollment]
- Normalisation MeAsure Development questionnaire (NoMAD) [Time frame: At clinician enrollment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Thomas Jefferson University — Philadelphia
Publications
- 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
Identifiers
NCT: NCT06638021 · 1R18HS029791-01