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Clinical Trials/NCT06638021
NCT06638021RecruitingNot Applicable

Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial

Thomas Jefferson University1 site in 1 country300 target enrollmentStarted: November 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Uncertainty Scale (U-Scale)

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

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)

Arms & Interventions

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.

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

Outcomes

Primary Outcomes

Uncertainty Scale (U-Scale)

Time Frame: 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 range of 30-150. Higher scores indicate greater uncertainty.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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