AI-assisted DocumentationNCT07750600
AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts
A study testing AI-assisted clinical documentation (ambient AI scribe, Tandem Health) in people with AI-assisted Documentation, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
Trial summary
Background: No randomized controlled trial evidence currently exists on the effectiveness of ambient artificial intelligence (AI)-assisted clinical documentation. Objective: To evaluate the effect of AI-assisted documentation on nurse productivity, professional experience, and documentation quality in nurse-led… 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 clinical documentation (ambient AI scribe, Tandem Health)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2026to Dec 2026
- 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
- Nurses at OmaHäme (Wellbeing Services County of Kanta-Häme) handling telephone or chat patient contacts
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Wellbeing Services County of Kanta-Häme (OmaHäme)
Hämeenlinna
Suvi Hämäläinen, MD, PhD, +35850 5917 162, suvi.hamalainen@omahame.fi
About this study
Official title: Effect of AI-Assisted Clinical Documentation on Nurse Productivity, Professional Experience, and Documentation Quality: A Randomized Repeated Crossover Trial in Primary Care Telehealth
Background: No randomized controlled trial evidence currently exists on the effectiveness of ambient artificial intelligence (AI)-assisted clinical documentation.
Objective: To evaluate the effect of AI-assisted documentation on nurse productivity, professional experience, and documentation quality in nurse-led telehealth (telephone and chat) contacts in Finnish primary care (Wellbeing Services County of Kanta-Häme, OmaHäme).
Read more
Methods: In this randomized, open-label, repeated crossover trial, approximately 64 nurses are allocated 1:1 to an ABAB or BABA sequence of four two-week periods (A = AI-assisted documentation, B = standard manual documentation) over eight weeks. The primary outcome is the number of patient contacts handled per nurse, analyzed with a generalized linear mixed-effects model for count data with nurse as a random effect; the treatment effect is expressed as an incidence rate ratio (IRR). A Monte Carlo simulation-based power analysis indicated 85% power to detect an IRR of 1.15 at a two-sided alpha of 0.05. Secondary outcomes include self-reported work-time savings, nurse experience and satisfaction, and patient satisfaction. Discrepancies between AI-generated draft notes, and final signed notes are analyzed to characterize the frequency, type, and clinical criticality of AI errors and omissions.
The trial is investigator-initiated (OmaHäme, HUS Helsinki University Hospital, University of Helsinki) and funded by the Strategic Research Council (GAINS project). The technology provider (Tandem Health) supplies the technical solution and participates in study design and manuscript preparation; responsibility for the study design, data analysis, and conclusions rests with the academic study group.
- Conditions
- AI-assisted Documentation
- Being tested
- AI-assisted clinical documentation (ambient AI scribe, Tandem Health)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted clinical documentation (ambient AI scribe, Tandem Health)Other
During AI-assisted periods, nurses use an ambient AI scribe that transcribes the patient contact and generates a draft clinical note, which the nurse reviews, edits, and approves. During control periods, nurses document contacts manually according to standard practice. All other aspects of care follow normal clinical routines.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABAB | Experimental | Nurses randomized to begin with AI-assisted documentation (A), alternating with standard manual documentation (B) in four consecutive two-week periods (A-B-A-B). Receives: Other: AI-assisted clinical documentation (ambient AI scribe, Tandem Health) |
| Sequence BABA. | Experimental | Nurses randomized to begin with standard manual documentation (B), alternating with AI-assisted documentation (A) in four consecutive two-week periods (B-A-B-A). Receives: Other: AI-assisted clinical documentation (ambient AI scribe, Tandem Health) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient contacts handled per nurse per working day/hour.
Count of telehealth (telephone/chat) contacts handled per nurse per working day/hour during time of excess demand extracted from routine service data.
Measured: Daily/hourly, over four 2-week periods (8 weeks).
Secondary outcomes (2)
Self-reported work-time savings.
Nurses' estimate of the effect of AI-assisted documentation on time spent on documentation, assessed with a study-specific end-of-study questionnaire (5-point Likert scale).
Measured: Week 8 (end of study).
Nurse-reported experience and satisfaction.
Perceived workflow, efficiency, workload, and job satisfaction, assessed with study-specific baseline and end-of-study questionnaires (5-point Likert scales).
Measured: Baseline (week 0) and week 8 (end of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (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.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated (ABAB/BABA) crossover design. Participating nurses are randomized 1:1 to one of two sequences: ABAB or BABA, where A denotes AI-assisted documentation and B standard manual documentation. Each sequence consists of four consecutive two-week periods (10 working days per period) over eight weeks, without washout periods. Each nurse serves as their own control.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tandem Health AB (technology provider), University of Helsinki, Wellbeing Services County of Kanta-Häme (OmaHäme)
- Responsible party
- Principal investigator, Ville Vartiainen, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750600
- Sponsor's protocol ID
- OMAHAME-AISCRIBE-2026
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level data contain sensitive personal and patient data processed under the GDPR and the Finnish Act on the Secondary Use of Health and Social Data; data are stored in the HUS Acamedic secure environment and cannot be shared as individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AI-Assisted Clinical Documentation on Nurse Productivity, Professional Experience, and Documentation Quality: A Randomized Repeated Crossover Trial in Primary Care Telehealth
- ClinicalTrials.gov ID
- NCT07750600
- Acronym / sponsor ID
- OMAHAME-AISCRIBE-2026
- Conditions
- AI-assisted Documentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Collaborators
- Tandem Health AB (technology provider), University of Helsinki, Wellbeing Services County of Kanta-Häme (OmaHäme)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (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: No randomized controlled trial evidence currently exists on the effectiveness of ambient artificial intelligence (AI)-assisted clinical documentation.
Objective: To evaluate the effect of AI-assisted documentation on nurse productivity, professional experience, and documentation quality in nurse-led telehealth (telephone and chat) contacts in Finnish primary care (Wellbeing Services County of Kanta-Häme, OmaHäme).
Methods: In this randomized, open-label, repeated crossover trial, approximately 64 nurses are allocated 1:1 to an ABAB or BABA sequence of four two-week periods (A = AI-assisted documentation, B = standard manual documentation) over eight weeks. The primary outcome is the number of patient contacts handled per nurse, analyzed with a generalized linear mixed-effects model for count data with nurse as a random effect; the treatment effect is expressed as an incidence rate ratio (IRR). A Monte Carlo simulation-based power analysis indicated 85% power to detect an IRR of 1.15 at a two-sided alpha of 0.05. Secondary outcomes include self-reported work-time savings, nurse experience and satisfaction, and patient satisfaction. Discrepancies between AI-generated draft notes, and final signed notes are analyzed to characterize the frequency, type, and clinical criticality of AI errors and omissions.
The trial is investigator-initiated (OmaHäme, HUS Helsinki University Hospital, University of Helsinki) and funded by the Strategic Research Council (GAINS project). The technology provider (Tandem Health) supplies the technical solution and participates in study design and manuscript preparation; responsibility for the study design, data analysis, and conclusions rests with the academic study group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeated (ABAB/BABA) crossover design. Participating nurses are randomized 1:1 to one of two sequences: ABAB or BABA, where A denotes AI-assisted documentation and B standard manual documentation. Each sequence consists of four consecutive two-week periods (10 working days per period) over eight weeks, without washout periods. Each nurse serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Sequence ABAB | Experimental | Other: AI-assisted clinical documentation (ambient AI scribe, Tandem Health)Nurses randomized to begin with AI-assisted documentation (A), alternating with standard manual documentation (B) in four consecutive two-week periods (A-B-A-B). |
| Sequence BABA. | Experimental | Other: AI-assisted clinical documentation (ambient AI scribe, Tandem Health)Nurses randomized to begin with standard manual documentation (B), alternating with AI-assisted documentation (A) in four consecutive two-week periods (B-A-B-A). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses at OmaHäme (Wellbeing Services County of Kanta-Häme) handling telephone or chat patient contacts
Key exclusion criteria (1 listed)
- None
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 clinical documentation (ambient AI scribe, Tandem Health)During AI-assisted periods, nurses use an ambient AI scribe that transcribes the patient contact and generates a draft clinical note, which the nurse reviews, edits, and approves. During control periods, nurses document contacts manually according to standard practice. All other aspects of care follow normal clinical routines. | Other | Sequence ABAB, Sequence BABA. |
Primary outcome
Number of patient contacts handled per nurse per working day/hour.
Time frame: Daily/hourly, over four 2-week periods (8 weeks).
Count of telehealth (telephone/chat) contacts handled per nurse per working day/hour during time of excess demand extracted from routine service data.
2 secondary outcomes
Self-reported work-time savings.
Time frame: Week 8 (end of study).
Nurse-reported experience and satisfaction.
Time frame: Baseline (week 0) and week 8 (end of study).
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 6 Aug 2026.
- Individual participant dataSharing planned: No. Individual-level data contain sensitive personal and patient data processed under the GDPR and the Finnish Act on the Secondary Use of Health and Social Data; data are stored in the HUS Acamedic secure environment and cannot be shared as individual participant data.
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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.
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 clinical documentation (ambient AI scribe, Tandem Health) in people with AI-assisted Documentation, run by Hospital District of Helsinki and Uusimaa 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 1 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: opening soon, as of the sponsor's last update on 6 Aug 2026. 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?
Contact Ville Vartiainen, MD, PhD, MSc (+358 50 430 6414, ville.vartiainen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient contacts handled per nurse per working day/hour. (time frame: Daily/hourly, over four 2-week periods (8 weeks).). 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 6 Aug 2026.