Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-10 @ 9:51 PM
Study NCT ID:
NCT06836258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of AI Assisted Documentation in Primary Health Care on Time Saving, Patient Satisfaction and Health Care Provider Satisfaction
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial on the Effectiveness of AI-Assisted Documentation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
None
Brief Summary:
Background There is currently no research evidence from randomized trial settings on the effectiveness of AI-assisted documentation. The aim of this study is to provide evidence regarding cost-effectiveness, professional experience, and patient experience.
Design Physician consultations participating in the study are randomized into AI-assisted and traditional documentation groups in a 1:1 repeated crossover design. The goal is to include approximately 1,000 consultations per group.
Methods Professionals will be asked to provide their own assessment of potential time savings, and the time spent on documentation will be measured using technical data from the documentation tools (cost-effectiveness). Additionally, professionals will complete baseline and follow-up surveys (professional experience), and patients will be sent a survey following the consultation (patient experience).
Design Physician consultations participating in the study are randomized into AI-assisted and traditional documentation groups in a 1:1 repeated crossover design. The goal is to include approximately 1,000 consultations per group.
Methods Professionals will be asked to provide their own assessment of potential time savings, and the time spent on documentation will be measured using technical data from the documentation tools (cost-effectiveness). Additionally, professionals will complete baseline and follow-up surveys (professional experience), and patients will be sent a survey following the consultation (patient experience).
Detailed Description:
The study will include all acute and non-acute visits for the enrolled clinician. The study excludes sector-specific work and specialized consultations, such as maternity clinics, memory clinics, intellectual disability consultations, as well as non-Finnish-language consultations and interpreter-assisted consultations. The system has been primarily designed to monitor discussions between two individuals, and therefore, consultations where a guardian or companion accompanies the patient are also excluded from the study.
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?: