Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments
研究概览
简要总结
The goal of this observational study is to learn whether family members can help identify signs of delirium in adult patients who are staying in the intensive care unit. Delirium is a sudden change in attention, thinking, or awareness that can happen during serious illness.
The main question it aims to answer is:
Can family members notice possible signs of delirium that may not be found during routine ICU delirium screening? Participants will receive their usual medical care. Family members who know the patient well will complete a short delirium assessment called the FAM-CAM after visiting the patient. Nurses will continue to perform routine ICU delirium screening using the ICDSC as part of usual care. The study team will compare the family member's assessment with the nurse's routine assessment to see whether family observations provide additional helpful information.
Family members may complete the assessment for up to 3 days while the patient is in the ICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 18 years or older.
- •Admitted to the ICU for at least 24 hours.
- •Richmond Agitation-Sedation Scale (RASS) score ≥ -3 at the time of enrollment.
- •Provided written informed consent to participate. When patients were unable to provide consent, consent was obtained from their legal surrogates.
- •Family Members:
- •Aged 18 years or older.
- •Identified as the patient's primary family caregiver.
- •Had visited the patient in the ICU at least once.
- •Were able to understand and communicate in Mandarin.
- •Provided written informed consent and voluntarily agreed to participate.
排除标准
- •Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -
- •A previously confirmed diagnosis of dementia, a severe psychiatric disorder, or an organic neurological disease.
- •Severe hearing impairment that prevented effective communication or study participation.
- •Family Members:
- •Significant visual, hearing, or cognitive problems that prevented them from understanding the study procedures or completing the study assessments.
研究组 & 干预措施
Delirium Assessment Using FAM-CAM, ICDSC, and CAM-ICU
In this observational study, participants will not receive any study treatment or experimental intervention. The study procedures include daily delirium assessments and routine clinical data collection.
Family members will complete one FAM-CAM assessment each day as soon as possible after the ICU visiting period ends.
The bedside nurse will independently complete one ICDSC assessment during the same assessment period and record both the assessment result and the time of completion.
A trained member of the research team will conduct one CAM-ICU assessment as the reference assessment, as close as practically possible to the FAM-CAM and ICDSC assessments.
All three assessments will be completed within a 1-hour period, and the exact completion time of each assessment will be recorded. All three assessments will be conducted independently, and assessors will remain blinded to the results of the other assessments to minimize mutual influence and assessment bias.
结局指标
主要结局
Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments
时间窗: once daily between 3:30 PM and 4:00 PM
This outcome will measure the level of agreement among the three assessment methods in the same patient and within the same general time frame.During the ICU phase, paired assessment data will be created according to the pairing rules described for the primary outcome. The results of FAM-CAM, ICDSC, and CAM-ICU will be classified as either "positive" or "negative."Agreement will be evaluated using Cohen's kappa coefficient as the main measure. The overall agreement rate, positive agreement rate, and negative agreement rate will also be reported as additional measures, together with 95% confidence intervals.
Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments
时间窗: once daily between 3:30 PM and 4:30 PM
This outcome will measure the level of agreement among the three assessment methods in the same patient and within the same general time frame.During the ICU phase, paired assessment data will be created according to the pairing rules described for the primary outcome. The results of FAM-CAM, ICDSC, and CAM-ICU will be classified as either "positive" or "negative."Agreement will be evaluated using Cohen's kappa coefficient as the main measure. The overall agreement rate, positive agreement rate, and negative agreement rate will also be reported as additional measures, together with 95% confidence intervals.
次要结局
- Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement(once daily between 3:30 PM and 4:00 PM)
- Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement(once daily between 3:30 PM and 4:30 PM)
研究者
Shining Cai
ICU Head Nurse
Shanghai Zhongshan Hospital