Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
Study NCT ID:
NCT05657002
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to the Impact of Accuracy Problem Lists in Electronic Health Records on Correctness and Speed of Clinical Decision-making Performed by Dutch Healthcare Providers
Sponsor:
Eva Klappe
Organization:
Study Overview
Official Title:
a Randomized Controlled Trial Study to Determine the Impact of Accuracy of Problem Lists in Electronic Health Records on Clinical Decision-making
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAM's APPLE
Brief Summary:
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-AMC-JK-7 | OTHER_GRANT | Amsterdam UMC | View |