Effects of AINurse Orientation Program on Psychological Outcomes and Length of Hospital Stay: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Delirium-free days
研究概览
简要总结
Artificial intelligence (AI), now an integral part of healthcare services and presents numerous opportunities. Customized treatment plans, clinical decision support systems, predictive analysis for disease prevention, patient engagement and education, quality improvement, and error reduction are some of these opportunities. In the context of delirium prevention, risk assessment, and treatment planning, the AI-supported system AI-AntiDelirium is designed to standardize the approach to delirium management in alignment with the PADIS guidelines. A randomized controlled trial evaluating the effectiveness of this system found that the workload of nurses decreased, facilitated early diagnosis and prevention of delirium, and recommended evidence-based and individualized delirium interventions. A systematic review concluded that AI applications did not significantly impact the length of hospital stay and emphasized the need for further research. Also, AI platforms contributed to positive results in reducing anxiety and depression in patients. Furthermore, systematic reviews have demonstrated that AI-based chatbots are effective in alleviating symptoms of depression and anxiety. However, the literature includes a limited number of patient education programs specifically designed to prevent or manage delirium through AI-based approaches. Notably, there is a lack of studies comparing the effectiveness of AI-supported educational interventions with those delivered directly by nurses.
The goal of this clinical trial is to develop a structured AINurse and Human Nurse orientation training program for intensive care unit (ICU) patients and compare the effects of these training programs on ICU patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. Hypotheses of the study:
H1: Patients who receive the structured AINurse patient orientation training program will have longer delirium-free days than patients who receive Human Nurse orientation training.
H2: Patients who receive the structured AINurse patient orientation training program will have lower levels of anxiety and depression than patients who receive the Human Nurse orientation training.
H3: Patients who receive the structured AINurse patient orientation training program will have shorter lengths of stay in the intensive care unit than patients who receive the Human Nurse orientation training.
Researchers will compare the AINurse patient orientation training program and the orientation training program provided by human nurses in terms of patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU.
- Those in the intervention group will receive the AINurse orientation training program twice daily for 3 days.
- Participants in the control group will receive face-to-face structured orientation training from researchers twice daily for 3 days.
- Delirium-free day assessment, anxiety and depression will be evaluated for patients in both groups over 3 days.
- The length of stay in the intensive care unit will be monitored for patients in both groups.
详细描述
The study is planned to be conducted in the adult intensive care unit of University Hospital, a tertiary care hospital in Türkiye. The general intensive care unit (GICU) of University Hospital has 16 beds and the cardiovascular surgery intensive care unit (CVSICU) has eight beds. The hospital where the study will be conducted has a total of 1950 patient admissions annually, 1500 in the GICU, and 450 adult patients in the CVSICU.
This study is designed as a single-center, randomized controlled experimental study. Although there are no similar studies available for calculating the sample size for this study, a pilot study with 10 patients will be conducted. Following the pilot study, the sample size will be calculated using G-Power analysis.
Recruitment, randomisation and blinding:
A computer-assisted simple randomization method will be used to assign eligible participants to study groups. The randomization process will be performed by a statistician independent of the researcher and communicated to the researcher. The website "https://www.random.org/integer-sets" will be used for this purpose.
Study Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intensive care unit confusion assessment scale (CAM-ICU scale) score of 0-2
- •Age 18 years or older
- •Hospitalized in the intensive care unit for at least 24 hours
- •Glasgow coma scale score of 13-14-15 points
- •Richmond Agitation Sedation Scale (RASS) score between -1 and +1
- •No hearing problems
排除标准
- •Intensive care unit confusion assessment scale (CAM-ICU scale) score of 6-7
- •Any psychiatric illness or impaired brain function
- •Defined hearing loss
- •Advanced dementia
- •Younger than 18 years of age
- •Richmond Agitation Sedation Scale (RASS) score outside the range of -1 to +1
- •Who use sedative medication
- •History of surgery or disease around the ear
结局指标
主要结局
Delirium-free days
时间窗: Before randomization, patients will be screened for delirium before being selected for the study.Patients scoring between 0 and 2 points will be included in the study. Subsequently, patients will be monitored for 3 days, with delirium assessed twice day.
The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale will be used to assess delirium-free days. CAM-ICU is utilized to assess the presence of delirium in critically ill patients. The CAM-ICU evaluates four key features in critically ill patients: (1) acute onset or fluctuating course of mental status, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking. A positive diagnosis of delirium is made when the first two criteria are present, along with either the third or fourth. The scale yields a total score ranging from 0 to 7, with interpretive cut-off points as follows: 0-2 indicating no delirium, 3-5 suggesting mild to moderate delirium, and 6-7 indicating severe delirium.
次要结局
- Level of anxiety and depression(It will be evaluated before and after the training for three days.)
- Length of stay in the intensive care unit(From the date of first randomization until discharge from the ICU , assessed up to 60 days or date of death from any cause (whichever came first))
研究者
Pelin Karacay
Associate Professor
Koç University