AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts

NCT07750600 — Not applicable, Not yet recruiting, 64 participants, Hospital District of Helsinki and Uusimaa

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Effect of AI-Assisted Clinical Documentation on Nurse Productivity, Professional Experience, and Documentation Quality: A Randomized Repeated Crossover Trial in Primary Care Telehealth

Registry	NCT07750600
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, health services research
Enrollment	64 (Estimated)
Sponsor	Hospital District of Helsinki and Uusimaa (Other); collaborators: Tandem Health AB (technology provider), University of Helsinki, Wellbeing Services County of Kanta-Häme (OmaHäme)
Conditions	AI-assisted Documentation
Interventions	AI-assisted clinical documentation (ambient AI scribe, Tandem Health) (Other)
Dates	start 2026-09-01 (estimated), primary completion 2026-10-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-08-06, last updated 2026-08-06
Locations	1 site in Finland

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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).

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.

+Outcome measures

Primary outcomes

Number of patient contacts handled per nurse per working day/hour. [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.

Secondary outcomes

Self-reported work-time savings. [Week 8 (end of study).]: 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).
Nurse-reported experience and satisfaction. [Baseline (week 0) and week 8 (end of study).]: Perceived workflow, efficiency, workload, and job satisfaction, assessed with study-specific baseline and end-of-study questionnaires (5-point Likert scales).

+Eligibility

Sex: All, accepts healthy volunteers

Inclusion Criteria:

* Nurses at OmaHäme (Wellbeing Services County of Kanta-Häme) handling telephone or chat patient contacts

Exclusion Criteria:

* None

+Locations (1)

Facility	City	Country	Status
Wellbeing Services County of Kanta-Häme (OmaHäme)	Hämeenlinna	Finland