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Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial

Improving Quality of ICD-10 (International Statistical Classification of Diseases, Tenth Revision) Coding Using AI: Protocol for a Crossover Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06286865
Acronym
ClinCode
Enrollment
15
Registered
2024-02-29
Start date
2023-10-20
Completion date
2024-05-31
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases

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.

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.

Interventions

OTHEREasy-ICD

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.

Sponsors

University Hospital of North Norway
Lead SponsorOTHER
The Research Council of Norway
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* participants outside Norway and Sweden

Design outcomes

Primary

MeasureTime frameDescription
Time1 hourTime in seconds taken to assign ICD-10 codes to each of the 20 clinical notes.
Accuracy1 hourAccuracy is calculated by dividing the number of correct ICD-10 codes by the total number of codes assigned.

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORHercules Dalianis, PhD

Norwegian Centre for E-health Research

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026