跳至主要内容
临床试验/NCT05657002
NCT05657002已完成不适用

a Randomized Controlled Trial Study to Determine the Impact of Accuracy of Problem Lists in Electronic Health Records on Clinical Decision-making

Eva Klappe2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
the correctness of the answer of medication B including the right motivation

研究概览

简要总结

The primary objective of this study is to determine whether patient records with complete, structured and up-to-date problem lists ('accurate problem lists'), result in better clinical decision-making, compared to patient records that convey the same information in a less structured way where the problem list has missing and/or duplicate diagnoses ('inaccurate problem lists'). The secondary objective is to determine whether the time required to make a correct decision is less for patient records with accurate problem lists compared to patient records with inaccurate problem lists.

详细描述

A problem list in Electronic Health Records (EHRs) is considered an essential feature in the collection of structured data. The problem list provides a centralized summary of each patient's medical problems and these problems or diagnoses are selected from the terminology underlying the problem list, such as SNOMED CT. If well maintained and structured, the problem list is a valuable tool for reviewing records of (unfamiliar) patients as it quickly shows the required information when needed. While studies have shown that the use of structured formats can serve as prompt for extra details, greater consistency of information and clinical decision-making there is little evidence whether a patient record with complete and structured problem lists results in more accurate and faster clinical decision making.

In the study (ADAM's APPLE: Adequate Data registration And Monitoring, subproject: Accurate Presentation of Problem List Elements), the investigators will perform a crossover randomized controlled trial in which a laboratory experiment will be performed among individual healthcare professionals to assess the impact of patient records with accurate and inaccurate problem lists on clinical decision-making. The participants will be presented with two records of two different patients in a training environment of the software system EPIC, one of them with an accurate problem list and the other that conveys the complete information in the patient record (in free text notes) but with an inaccurate problem list with missing diagnoses and duplicate information. The participants do not know which of the two records includes the accurate problem list and which record includes the inaccurate problem list. Participants are asked to decide whether or not to prescribe two medications for those two patients. One medication is not allowed per patient because the patient is allergic to that medication, which is documented on the allergy list. For the first patient record, the other medication is not allowed, because of a contraindicated diagnosis and for the second patient record the other medication is not allowed, because of a side effect that has occurred using that medication in the medical history. Based on the correctness of the motivation for correct answers and the time to the right answers, the research question if accurate problem lists in patient records lead to better and faster decision-making is answered.

Prior to this study, two healthcare professionals in the research team determined suitable use cases and questions for this study. These use cases were based on real-world unstructured versions of patient records. Two optimized accurate problem lists were also created for both patient records, which was defined according to the problem list policy at our institution (i.e. all current active problems and relevant medical history should be documented on the problem list).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

Participant will be blinded, they do not know in what group they belong (thus which record they receive with the accurate or inaccurate problem list) and the participants are not informed that impact of problem list accuracy is investigated.

An independent researcher produced a randomization schema where per block of 10 participants a balanced random order of "patient A with accurate problem list + patient B with inaccurate problem list" or "patient A with inaccurate problem list + patient B with accurate problem list" is produced. The investigator (ESK) follows this list for the consecutive participants and gives access to the appropriate patient records as defined by the randomisation schema. The independent researcher checks afterwards whether the right order is followed based on time stamps and randomisation schema.

We performed a power analysis before conducting any experiment, which resulted in a required number of 157 participants.

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthcare professionals who are allowed to prescribe medication, thus hold a position as: medical specialist, medical resident, nurse specialist or physician assistant, research-specialists
  • Healthcare professionals must have followed at least the 'basic EHR Epic course'. This electronic health record course lasts for three days and includes how to send letters, register diagnoses in a record, request testing, all in the software system EPIC, which concludes with an exam on the theory.

排除标准

  • Non-Dutch speaking employees as the patient cases and the exercises are described in Dutch

结局指标

主要结局

the correctness of the answer of medication B including the right motivation

时间窗: during the experiment/questionnaire

Measured using a questionnaire showing the two question(s) per patient record on a separate tablet during the experiment. Two Yes/No questions per patient record (so a total of four questions per participant) are answered. Answers are stored using an automatically assigned unique anonymized identifier. The question for both patient records is: "can the patient be prescribed medication A and/or B?". Medications A and B can both not be prescribed, but medication B is related to the problem list diagnoses and medication A is related to the allergy list which is the same for both versions of the patient records. A motivation is required per Yes/No answer to determine the correctness of the answer and prevent from a chance of gambling. An independent researcher from the research team who did not perform the experiments will categorize the motivation of the answers for medication B.

次要结局

  • the total time to answer the two questions correctly, where the answer of medication B also includes the right motivation(during the experiment/questionnaire)
  • the total time to answer the two questions correctly including the right motivations for medication A and B(during the experiment/questionnaire)
  • the correctness of both the answer for medication A and B including the right motivations for A and B(during the experiment/questionnaire)
  • the correctness of the answer for medication A including the right explanation(during the experiment/questionnaire)

研究者

发起方
Eva Klappe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eva Klappe

PhD Candidate

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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