Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-07
Brief Title:
Targeted EHR-based Communication of Diagnostic Uncertainty in the ED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeted EHR-based Communication of Diagnostic Uncertainty TECU in the ED an Effectiveness Implementation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TECU
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 pilot 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
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 pilot 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None