NCT06286865

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 16, 2024

Last Update Submit

February 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time

    Time in seconds taken to assign ICD-10 codes to each of the 20 clinical notes.

    1 hour

  • Accuracy

    Accuracy is calculated by dividing the number of correct ICD-10 codes by the total number of codes assigned.

    1 hour

Study Arms (2)

Easy-ICD interface

ACTIVE COMPARATOR

This arm uses our AI-based computer-assisted clinical coding (CAC) system, Easy-ICD

Other: Easy-ICD

Control interface

NO INTERVENTION

This control arm uses an interface similar to Easy-ICD, but without the AI functionality

Interventions

Easy-ICD is an AI-based computer-assisted clinical coding (CAC) system that helps clinical coder assign ICD-10 codes to clinical notes such as discharge summaries.

Easy-ICD interface

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • participant has coded clinical texts before, preferably ICD-10 coding
  • is a healthcare professional, eg. clinician, nurse, professional coders
  • can understand Swedish

You may not qualify if:

  • participants outside Norway and Sweden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Centre for E-health Research

Tromsø, Troms, 9019, Norway

RECRUITING

Related Publications (1)

  • Chomutare T, Lamproudis A, Budrionis A, Svenning TO, Hind LI, Ngo PD, Mikalsen KO, Dalianis H. Improving Quality of ICD-10 (International Statistical Classification of Diseases, Tenth Revision) Coding Using AI: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 12;13:e54593. doi: 10.2196/54593.

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Hercules Dalianis, PhD

    Norwegian Centre for E-health Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 29, 2024

Study Start

October 20, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

The data we collect in the study are all anonymous and will be shared publicly after the user study is published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
At the publishing of the user study.
Access Criteria
The anonymous data will be publicly available.

Locations