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临床试验/NCT07750600
NCT07750600尚未招募不适用

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

Hospital District of Helsinki and Uusimaa1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Number of patient contacts handled per nurse per working day/hour.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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).

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

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).

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Self-reported work-time savings.(Week 8 (end of study).)
  • Nurse-reported experience and satisfaction.(Baseline (week 0) and week 8 (end of study).)

研究者

发起方
Hospital District of Helsinki and Uusimaa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ville Vartiainen

Docent, MD, PhD, MSc, Researcher

Hospital District of Helsinki and Uusimaa

研究点 (1)

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