AI-assisted DocumentationNCT06836258
Effect of AI Assisted Documentation in Primary Health Care on Time Saving, Patient Satisfaction and Health Care Provider Satisfaction
A study testing AI assisted documentation in people with AI-assisted Documentation, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- AI-assisted Documentation
- What is being tested?
- AI assisted documentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinician practices at a site in Western Uusimaa wellbeing services county where AI-assisted documentation tool is available
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Western Uusimaa Welbeing services county
Espoo, Nummela, Kirkkonummi
About this study
Official title: A Randomized Clinical Trial on the Effectiveness of AI-Assisted Documentation
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).
Read the 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.
- Conditions
- AI-assisted Documentation
- Being tested
- AI assisted documentation
- Keywords
- AI, documentation, Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted documentationOther
This study will use Gosta Aide AI-assisted documentation platform
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AI assisted documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until the of study (approx two months).
Secondary outcomes (7)
Subjective time saving in documentation due to AI-assisted documentation
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).
Measured: Assessed once a day after the days appointments and records have been completed through study completion, expected 2 months..
Clinician satisfaction questionnaire
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)
Measured: At the end of the study (expected two months)
Clinician satisfaction by Net Promotor Score (NPS)
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.
Measured: At the end of the study (expected two months)
Clinician satisfaction by willingness to continue with the tool
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)
Measured: At the end of the study (expected two months)
Patient satisfaction by Net Promotor Score (NPS)
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.
Measured: Immediately after the randomized appointment
Patient satisfaction by Patient Enablement Instrument (PEI)
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.
Measured: Immediately after the randomized appointment
Patient satisfaction by The Patient Satisfaction Questionnaire Short Form (PSQ-18)
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.
Measured: Immediately after the randomized appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-assisted DocumentationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- Single-arm repeated crossover design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Western Uusimaa Welbeing Services county
- Responsible party
- Principal investigator, Ville Vartiainen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836258
- Sponsor's protocol ID
- GA-RCT-1
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contains sensitive information and cannot be shared due to Finnish research legislation
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Effectiveness of AI-Assisted Documentation
- ClinicalTrials.gov ID
- NCT06836258
- Acronym / sponsor ID
- GA-RCT-1
- Conditions
- AI-assisted Documentation
- Keywords
- AI, documentation, Effectiveness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Western Uusimaa Welbeing Services county
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm repeated crossover design
| Arm | Type | Receives |
|---|---|---|
| AI-assisted documentation vs regular documentation | Other | Other: AI assisted documentationAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinician practices at a site in Western Uusimaa wellbeing services county where AI-assisted documentation tool is available
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI assisted documentationThis study will use Gosta Aide AI-assisted documentation platform | Other | AI-assisted documentation vs regular documentation |
Primary outcome
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.
7 secondary outcomes
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..
Clinician satisfaction questionnaire
Time frame: At the end of the study (expected two months)
Clinician satisfaction by Net Promotor Score (NPS)
Time frame: At the end of the study (expected two months)
Clinician satisfaction by willingness to continue with the tool
Time frame: At the end of the study (expected two months)
Patient satisfaction by Net Promotor Score (NPS)
Time frame: Immediately after the randomized appointment
Patient satisfaction by Patient Enablement Instrument (PEI)
Time frame: Immediately after the randomized appointment
Patient satisfaction by The Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time frame: Immediately after the randomized appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Data contains sensitive information and cannot be shared due to Finnish research legislation
Related trials for AI-assisted Documentation
Not yet recruiting
A Pragmatic Trial of AI-Assisted Discharge Summary Generation
Inpatient Internal Medicine Patients, Patient Discharge
Not yet recruiting
AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts
AI-assisted Documentation
Not yet recruiting
Effectiveness of AI-Assisted Clinical Documentation
Effectiveness of AI-assisted Clinical Documentation Tool, Healthy
Not yet recruiting
The Accuracy and Efficacy of Large Language Model Written Hospital Course Summaries
Hospitalizations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI assisted documentation in people with AI-assisted Documentation, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time saved using AI-assisted documentation (time frame: From enrollment until the of study (approx two months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.