Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286865
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-16
Brief Title:
Improving Quality of ICD-10 Coding Using AI Protocol for a Crossover Randomized Controlled Trial
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Improving Quality of ICD-10 International Statistical Classification of Diseases Tenth Revision Coding Using AI Protocol for a Crossover Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
ClinCode
Brief Summary:
The goal of this randomised trial is to learn about the role of AI in clinical coding practice The main question it aims to answer is
Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding Participants will be asked to code clinical texts both while they use our CAC system and while they do not
Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding Participants will be asked to code clinical texts both while they use our CAC system and while they do not
Detailed Description:
Once participants are recruited they are randomly allocated to 2 groups without allocation concealment Allocation concealment will not be relevant for clinical coders since it is known whether a participant is assisted or not and we will not develop a placebo coding assistant We will however conceal the allocation of subjects for the analyses
In total participants will code 20 clinical notes where each note belongs to a single patient The participants are asked to complete the experiment in 1 sitting without interruptions and they cannot revisit or go back to previous notes In the event that participants are interrupted they are asked to exit the experiment and any incomplete records are discarded as invalid
The user study process can be summarized in the following steps
1 Study participants are randomly allocated to group 1 and group 2
2 To prepare participants for the experiment a short video tutorial is played after the consent form is signed and right before the clinical coding task commences
3 In period 1 with 10 clinical notes group 1 uses the control interface while group 2 uses the intervention interface
4 Data are logged in the background using button presses eg time assigned codes and comments
5 Then there is an immediate crossover to period 2 for the last 10 clinical notes
6 Data continue to be logged in the background using button presses
7 At the end participants in both groups will complete the system usability scale
In total participants will code 20 clinical notes where each note belongs to a single patient The participants are asked to complete the experiment in 1 sitting without interruptions and they cannot revisit or go back to previous notes In the event that participants are interrupted they are asked to exit the experiment and any incomplete records are discarded as invalid
The user study process can be summarized in the following steps
1 Study participants are randomly allocated to group 1 and group 2
2 To prepare participants for the experiment a short video tutorial is played after the consent form is signed and right before the clinical coding task commences
3 In period 1 with 10 clinical notes group 1 uses the control interface while group 2 uses the intervention interface
4 Data are logged in the background using button presses eg time assigned codes and comments
5 Then there is an immediate crossover to period 2 for the last 10 clinical notes
6 Data continue to be logged in the background using button presses
7 At the end participants in both groups will complete the system usability scale
Study Oversight
Has Oversight DMC:
None
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?:
None