AI-Assisted Clinical Documentation in Nurse-Led Telehealth Contacts

NCT07750600 | Not Yet Recruiting

• 1 other identifier: OMAHAME-AISCRIBE-2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily/hourly, over four 2-week periods (8 weeks).

Secondary Outcomes (2)

• Self-reported work-time savings.

  Week 8 (end of study).

• Nurse-reported experience and satisfaction.

  Baseline (week 0) and week 8 (end of study).

Study Arms (2)

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).

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).

Other: AI-assisted clinical documentation (ambient AI scribe, Tandem Health)

Interventions

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.

Sequence ABAB; Sequence BABA.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital District of Helsinki and Uusimaa: lead
• Tandem Health AB (technology provider): collaborator
• University of Helsinki: collaborator
• Wellbeing Services County of Kanta-Häme (OmaHäme): collaborator

Study Sites (1)

Wellbeing Services County of Kanta-Häme (OmaHäme)

Hämeenlinna, Finland

Location

Central Study Contacts

Ville Vartiainen, MD, PhD, MSc

CONTACT

+358 50 430 6414; ville.vartiainen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent, MD, PhD, MSc, Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)