Clinical trial NCT06836258: Effect of AI Assisted Documentation in Primary Health Care on Time Saving, Patient Satisfaction and Health Care Provider Satisfaction
Official title: A Randomized Clinical Trial on the Effectiveness of AI-Assisted Documentation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AI-assisted Documentation
Keywords: AI
documentation
Effectiveness
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Western Uusimaa Welbeing Services county
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Single-arm repeated crossover design
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time saved using AI-assisted documentation
timeFrame: From enrollment until the of study (approx two months).
Secondary outcomes:
measure: Subjective time saving in documentation due to AI-assisted documentation
timeFrame: Assessed once a day after the days appointments and records have been completed through study completion, expected 2 months..
measure: Clinician satisfaction questionnaire
timeFrame: At the end of the study (expected two months)
measure: Clinician satisfaction by Net Promotor Score (NPS)
timeFrame: At the end of the study (expected two months)
measure: Clinician satisfaction by willingness to continue with the tool
timeFrame: At the end of the study (expected two months)
measure: Patient satisfaction by Net Promotor Score (NPS)
timeFrame: Immediately after the randomized appointment
measure: Patient satisfaction by Patient Enablement Instrument (PEI)
timeFrame: Immediately after the randomized appointment
measure: Patient satisfaction by The Patient Satisfaction Questionnaire Short Form (PSQ-18)
timeFrame: Immediately after the randomized appointment
Other outcomes:
Locations:
city: Espoo, Nummela, Kirkkonummi
country: Finland
facility: Western Uusimaa Welbeing services county
Study officials:
References: