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Not yet recruiting NCT07750600

AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts

No phase Interventional AI-assisted Documentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-assisted clinical documentation (ambient AI scribe, Tandem Health).
Who it may be relevant to
Registry conditions: AI-assisted Documentation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

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.

Primary outcome measures

  • Number of patient contacts handled per nurse per working day/hour. [Time frame: Daily/hourly, over four 2-week periods (8 weeks).]
Secondary outcome measures (2)
  • 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).]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

Finland · 1 center
  • Wellbeing Services County of Kanta-Häme (OmaHäme) — Hämeenlinna

Identifiers

NCT: NCT07750600 · OMAHAME-AISCRIBE-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗