Targeted EHR-based Communication of Diagnostic Uncertainty in the ED
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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)
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 range of 30-150. Higher scores indicate greater uncertainty.
- 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 care transition, with lower scored indicating a poorer quality transition, and higher scores indicating a better transition.
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