Targeted EHR-based Communication of Diagnostic Uncertainty in the ED

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Targeted EHR-based Communication of Diagnostic Uncertainty (TECU)

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Pre-TECU ImplementationNo intervention 0 interventions
Group B: Post-TECU ImplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
enrollment

Secondary outcomes

1

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.

Time frame
2 days post enrollment
2

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.

Time frame
2 days post enrollment
3

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.

Time frame
At clinician enrollment

Other outcomes

1

Return emergency department (ED) visits

As the TECU is designed to improve quality of the ED discharge for patients with diagnostic uncertainty, the investigators hypothesize that ED recidivism will decrease for patients receiving the TECU-guided discharge. The investigators will evaluate rates of ED return at 9 days and 30 days. Rates of ED return and subsequent outpatient care encounters will be assessed through patient self-report at T2 (30 days) and EHR review.

Time frame
9 days post enrollment
2

Return emergency department (ED) visits

As the TECU is designed to improve quality of the ED discharge for patients with diagnostic uncertainty, the investigators hypothesize that ED recidivism will decrease for patients receiving the TECU-guided discharge. The investigators will evaluate rates of ED return at 9 days and 30 days. Rates of ED return and subsequent outpatient care encounters will be assessed through patient self-report at T2 (30 days) and EHR review.

Time frame
30 days post enrollment
3

Composite healthcare utilization

The investigators acknowledge that it is possible that, when better informed about their lack of a diagnosis, total healthcare utilization may increase as patients continue to pursue a diagnosis through outpatient visits with their primary physician or specialists. The investigators will assess 30-day composite counts of all healthcare interactions including: ED and clinic visits, admissions, testing appointments, telephone or EHR-message interactions. Data will be obtained through patient self report as well as EHR queries.

Time frame
30 days post enrollment
4

Spielberger State-Trait Anxiety Inventory (STAI-AD)

The 6-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI-AD) scale of this gold-standard measure provides a reliable and sensitive measure of anxiety in relation to an event. The 6-item STAI-ID is scored using a 4-point Likert scale (1: Not at all, 2: Somewhat, 3: Moderately so, 4: Very much so), with higher scores indicating more anxiety. Scores can range from 6-24; Scores above 15 indicate the presence of anxiety symptoms.

Time frame
enrollment

Sponsors and contacts

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Thomas Jefferson University

Lead sponsor

Northwestern University

Collaborator

Washington University School of Medicine

Collaborator