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NCT Number: NCT06836258

Effect of AI Assisted Documentation in Primary Health Care on Time Saving, Patient Satisfaction and Health Care Provider Satisfaction

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Uusimaa Welbeing services county

Espoo, Nummela, Kirkkonummi, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI assisted documentation

Other

This study will use Gosta Aide AI-assisted documentation platform

Primary outcomes

  1. Time saved using AI-assisted documentation

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

    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.

Secondary outcomes

  1. Subjective time saving in documentation due to AI-assisted documentation

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

    Each clinician will give their subjective assessment the time saved or wasted due to AI tool per appointment (in minutes) after each day through study completion (approximately two months).

  2. Clinician satisfaction questionnaire

    Time frame: At the end of the study (expected two months)

    Clinicans will report their satisfaction by assessing the effect of AI tool to quality of documentation. The questionnaire includes three questions answered in 1-5 likert scale where 1 worst and 5 best outcome. The questions are "How has AI affected time used in documentation?" (1 = IIncreased the time spent on documentation significantly, 5 = Decreased the time spent on documentation significantly) "How has AI affected the quality of documentation?" (1 = Decreased the quality of documentation significantly, 5 = Increased the quality of documentation significantly) "How has AI affected patient safety?" (1 = Significantly compromised patient safety, 5 = Significantly improved patient safety)

  3. Clinician satisfaction by Net Promotor Score (NPS)

    Time frame: At the end of the study (expected two months)

    Clinicans will report their satisfaction (regarding AI tool) by NPS. The question is stated "Would you recommend AI assisted documentation to your colleague?" and is assessed in scale 0-10 where 0 means would not recommend and 10 is would recommend extremely highly.

  4. Clinician satisfaction by willingness to continue with the tool

    Time frame: At the end of the study (expected two months)

    Clinicans will report their satisfaction by assessing whether they would like to continue with the AI-tool or using regular method. The question is stated "In future, would you prefer to do clinical documentation with the now used AI-based tool or as you were doing previously without the AI-based tool?" (With AI-tool/Without AI-tool)

  5. Patient satisfaction by Net Promotor Score (NPS)

    Time frame: Immediately after the randomized appointment

    Patient satisfaction will be assessed after each appointemnt using NPS. The patients who visit a participating clinician will receive a questionnaire including NPS once after each of their appointment. The scale is 0-10 where 0 is would not recommend the appointment at all and 10 would highly recommend the appointment.

  6. Patient satisfaction by Patient Enablement Instrument (PEI)

    Time frame: Immediately after the randomized appointment

    Patient satisfaction will be assessed after each appointemnt using PEI questionnaire. The patients who visit a participating clinician will receive a questionnaire including PEI once after each of their appointment. Score ranges between 0-12 and higher score indicates better outcome for the patient.

  7. Patient satisfaction by The Patient Satisfaction Questionnaire Short Form (PSQ-18)

    Time frame: Immediately after the randomized appointment

    Patient satisfaction will be assessed after each appointment using PSQ18 questionnaire. The patients who visit a participating clinician will receive a questionnaire including PSQ18 once after each of their appointment. Score ranges from 18 to 90 and higher score indicates worse patient experience.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki
  • Western Uusimaa Welbeing Services county

Registry information

Official study title

A Randomized Clinical Trial on the Effectiveness of AI-Assisted Documentation

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.