AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts
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).
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ville Vartiainen, MD, PhD, MSc
- Numéro de téléphone: +358 50 430 6414
- E-mail: ville.vartiainen@hus.fi
Lieux d'étude
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Hämeenlinna, Finlande
- Wellbeing Services County of Kanta-Häme (OmaHäme)
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Contact:
- Suvi Hämäläinen, MD, PhD
- Numéro de téléphone: +35850 5917 162
- E-mail: suvi.hamalainen@omahame.fi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Nurses at OmaHäme (Wellbeing Services County of Kanta-Häme) handling telephone or chat patient contacts
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Sequence ABAB
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).
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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.
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Expérimental: Sequence BABA.
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).
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of patient contacts handled per nurse per working day/hour.
Délai: Daily/hourly, over four 2-week periods (8 weeks).
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Count of telehealth (telephone/chat) contacts handled per nurse per working day/hour during time of excess demand extracted from routine service data.
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Daily/hourly, over four 2-week periods (8 weeks).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-reported work-time savings.
Délai: Week 8 (end of study).
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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).
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Week 8 (end of study).
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Nurse-reported experience and satisfaction.
Délai: Baseline (week 0) and week 8 (end of study).
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Perceived workflow, efficiency, workload, and job satisfaction, assessed with study-specific baseline and end-of-study questionnaires (5-point Likert scales).
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Baseline (week 0) and week 8 (end of study).
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- OMAHAME-AISCRIBE-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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