NCT06836258

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).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

January 22, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 22, 2025

Last Update Submit

August 10, 2025

Conditions

Keywords

AIdocumentationEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Time saved using AI-assisted documentation

    The documentation platform will measure time used for documentation of the appointment for both AI-assisted and regular documentation. For each appointment separately, from the moment the patient leaves the appointment until the documentation is finished and saved to the patient records.

    From enrollment until the of study (approx two months).

Secondary Outcomes (7)

  • Subjective time saving in documentation due to AI-assisted documentation

    Assessed once a day after the days appointments and records have been completed through study completion, expected 2 months..

  • Clinician satisfaction questionnaire

    At the end of the study (expected two months)

  • Clinician satisfaction by Net Promotor Score (NPS)

    At the end of the study (expected two months)

  • Clinician satisfaction by willingness to continue with the tool

    At the end of the study (expected two months)

  • Patient satisfaction by Net Promotor Score (NPS)

    Immediately after the randomized appointment

  • +2 more secondary outcomes

Study Arms (1)

AI-assisted documentation vs regular documentation

OTHER

All subjects (clinicians) will be in a single arm. However, appointmets of each clinican will be randomized into AI-assisted and traditional documentation groups in 1:1.

Other: AI assisted documentation

Interventions

This study will use Gosta Aide AI-assisted documentation platform

AI-assisted documentation vs regular documentation

Eligibility Criteria

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

You may qualify if:

  • Clinician practices at a site in Western Uusimaa wellbeing services county where AI-assisted documentation tool is available

You may not qualify if:

  • none
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Uusimaa Welbeing services county

Espoo, Nummela, Kirkkonummi, Finland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Single-arm repeated crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MSc

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 20, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

August 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data contains sensitive information and cannot be shared due to Finnish research legislation

Locations