Diagnostic UncertaintyTECUNCT06638021
Targeted EHR-based Communication of Diagnostic Uncertainty in the ED
A study testing Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in people with Diagnostic Uncertainty, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Uncertainty
- What is being tested?
- Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Amanda MB Doty, MS, 2155034619, amanda.doty@jefferson.edu
Philip Watts, 215-520-7595, Phillip.Watts@jefferson.edu
About this study
Official title: Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial
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.
Read the 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.
- Conditions
- Diagnostic Uncertainty
- Being tested
- Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)
- Keywords
- Patient uncertainty, Symptom-based diagnosis, ED Discharge Communication, Diagnostic Uncertainty, Best practice advisory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: enrollment
Secondary outcomes (3)
The Care Transition Measure (CTM)-3
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 care transition, with lower scored indicating a poorer quality transition, and higher scores indicating a better transition.
Measured: 2 days post enrollment
Transitions During Uncertainty (TDU) questionnaire
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.
Measured: 2 days post enrollment
Normalisation MeAsure Development questionnaire (NoMAD)
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.
Measured: At clinician enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic UncertaintyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- pre-post hybrid type 1 effectiveness implementation design
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin L Rising, MD, MS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638021
- Sponsor's protocol ID
- 1R18HS029791-01
- Acronym
- TECU
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40204252