跳至主要内容
临床试验/NCT06638021
NCT06638021招募中不适用

Targeted EHR-based Communication of Diagnostic Uncertainty (TECU) in the ED: An Effectiveness Implementation Trial

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Uncertainty Scale (U-Scale)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Uncertainty Scale (U-Scale)

时间窗: 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.

次要结局

  • The Care Transition Measure (CTM)-3(2 days post enrollment)
  • Transitions During Uncertainty (TDU) questionnaire(2 days post enrollment)
  • Normalisation MeAsure Development questionnaire (NoMAD)(At clinician enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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