Clinical trial NCT06638021: Targeted EHR-based Communication of Diagnostic Uncertainty in the ED
Official title: Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diagnostic Uncertainty
Keywords: Patient uncertainty
Symptom-based diagnosis
ED Discharge Communication
Diagnostic Uncertainty
Best practice advisory
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Washington University School of Medicine
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: pre-post hybrid type 1 effectiveness implementation design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Uncertainty Scale (U-Scale)
timeFrame: enrollment
Secondary outcomes:
measure: The Care Transition Measure (CTM)-3
timeFrame: 2 days post enrollment
measure: Transitions During Uncertainty (TDU) questionnaire
timeFrame: 2 days post enrollment
measure: Normalisation MeAsure Development questionnaire (NoMAD)
timeFrame: At clinician enrollment
Other outcomes:
measure: Return emergency department (ED) visits
timeFrame: 9 days post enrollment
measure: Return emergency department (ED) visits
timeFrame: 30 days post enrollment
measure: Composite healthcare utilization
timeFrame: 30 days post enrollment
measure: Spielberger State-Trait Anxiety Inventory (STAI-AD)
timeFrame: enrollment
measure: Spielberger State-Trait Anxiety Inventory (STAI-AD)
timeFrame: 2 days post enrollment
measure: Spielberger State-Trait Anxiety Inventory (STAI-AD)
timeFrame: 30 days post enrollment
measure: Care Transition Measure
timeFrame: 30 days post enrollment
measure: Uncertainty Scale (U-Scale)
timeFrame: 30 days post enrollment
measure: Uncertainty Scale (U-Scale)
timeFrame: 2 days post enrollment
measure: Uncertainty Scale (U-Scale) Treatment Quality subdomain
timeFrame: 2 days post enrollment
measure: Uncertainty Scale (U-Scale) Treatment Quality subdomain
timeFrame: 30 days post enrollment
measure: User feedback
timeFrame: 30 days (patients), enrollment (clinicians)
measure: Clinical Sustainability Assessment Tool (CSAT)
timeFrame: At clinician enrollment
measure: Uncertainty Scale (U-Scale) Treatment Quality subdomain
timeFrame: enrollment
measure: Transitions During Uncertainty (TDU) questionnaire
timeFrame: enrollment
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Kristin L Rising, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: