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AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts

NCT07750600 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • AI-assisted Documentation

Interventions

OTHER

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.

Sponsors & Collaborators

  • Tandem Health AB (technology provider)

    collaborator UNKNOWN

  • University of Helsinki

    collaborator OTHER

  • Wellbeing Services County of Kanta-Häme (OmaHäme)

    collaborator UNKNOWN

  • Hospital District of Helsinki and Uusimaa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750600 on ClinicalTrials.gov