Effect of AI-Assisted Clinical Documentation on Nurse Productivity, Professional Experience, and Documentation Quality: A Randomized Repeated Crossover Trial in Primary Care Telehealth
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
- 是
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
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.
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
Ville Vartiainen
Docent, MD, PhD, MSc, Researcher
Hospital District of Helsinki and Uusimaa
