NCT Number: NCT06638021
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
Amanda MB Doty, MS
CONTACT
Benjamin Leiby, PhD
SUB_INVESTIGATOR
Danielle McCarthy, MD, MS
PRINCIPAL_INVESTIGATOR
Dimitrios Papanagnou, MD PhD
SUB_INVESTIGATOR
Kristin L Rising, MD, MS
PRINCIPAL_INVESTIGATOR
Philip Watts
CONTACT
Rahul Yadav, MD
SUB_INVESTIGATOR
Sara Malone, LCSW, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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.
Other names: TECU
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 days post enrollment
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
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
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: enrollment
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: 2 days post enrollment
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: 30 days post enrollment
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: 30 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.
Time frame: 30 days post 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.
Time frame: 2 days post 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.
Time frame: 2 days post enrollment
The Uncertainty Scale (U-Scale) assesses patient-level uncertainty related to acute symptoms - while the U-Scale in its entirety is being assessed, the investigators also will assess for differences specifically in the uncertainty related to treatment quality subdomain, as this has been associated with return ED visits and contains the questions most immediately linked to the care and communication received during the ED visit.
Time frame: 30 days post enrollment
The Uncertainty Scale (U-Scale) assesses patient-level uncertainty related to acute symptoms - while the U-Scale in its entirety is being assessed, the investigators also will assess for differences specifically in the uncertainty related to treatment quality subdomain, as this has been associated with return ED visits and contains the questions most immediately linked to the care and communication received during the ED visit.
Time frame: 30 days (patients), enrollment (clinicians)
Patient and clinician experience data obtained via interviews and focus groups
Time frame: At clinician enrollment
The Clinical Sustainability Assessment Tool (CSAT) assesses organizational capacity for sustainability. The investigators will use the CSAT to conduct summative implementation assessment with clinicians exposed to the TECU intervention. The CSAT total score ranges from 1 to 7, with higher scores indicating a greater capacity for clinical sustainability.
Time frame: enrollment
The Uncertainty Scale (U-Scale) assesses patient-level uncertainty related to acute symptoms - while the U-Scale in its entirety is being assessed, the investigators also will assess for differences specifically in the uncertainty related to treatment quality subdomain, as this has been associated with return ED visits and contains the questions most immediately linked to the care and communication received during the ED visit.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Amanda MB Doty, MS
CONTACT
Kristin L Rising, MD, MS
CONTACT
Thomas Jefferson University
Other
Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial
Acronym: TECU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01752673
Cardiovascular Diseases, Clinical Reasoning
Calgary, Alberta, Canada
View Trial Details