Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,890
- 试验地点
- 5
- 主要终点
- Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)
研究概览
简要总结
The overall goal is to reduce the incidence and burden of delirium, as measured by the delirium burden index (DBI) among hospitalized older adults (≥70 years), by modifying the inpatient environment to decrease its sleep antagonism. The investigators propose to implement a multi-modal sleep hygiene (MMSH) bundle, an enhancement of a previously reported sleep-focused intervention which had 88 - 100% compliance for intervention components, and reduced ICU delirium by 50%.
详细描述
The Investigators will implement the MMSH in a randomized step-wedge cluster design across 11 independent nursing units of 4 Methodist hospitals. While primarily focusing on the MMSH effectiveness, the investigators will conduct process evaluation to identify barriers and facilitators for MMSH implementation.
Specific Aim 1: Establish the comparative effectiveness of an in-hospital, MMSH towards reducing the rate of incident (hospital acquired) delirium (HAD) among older adults (age ≥ 70). The investigators will compare the rate of incident delirium between patients receiving the MMSH bundle in addition to the Standard of Care delirium screening and prevention protocol (SOC-DSPP), and those who are managed only under the SOC-DSPP. The SOC-DSPP through out all HM units includes twice daily deliruim screening with the 4AI. Outcome: The primary outcome is incident delirium (or HAD), determined by a positive 4AT, among patients who did not have delirium present on admission. The investigators hypothesize a 33% reduction in incident delirium among patients receiving the MMSH bundle.
Specific Aim 2: Establish the comparative effectiveness of an in-hospital, MMSH towards reducing delirium burden, as measured by DBI, among older adults (age ≥ 70), either with HAD or with D-POA. The investigators will compare the DBI between patients receiving the MMSH bundle in addition to the SOC-DSPP with that of those who were managed only under the SOC-DSPP. Outcome: The primary outcome is patient-level DBI [(number of positive 4AT screens)2/total number of 4AT screens)]. The DBI will be a non-zero positive fraction which is scale free because it accounts for the duration of observation by taking into consideration the total number of delirium assessments. Investigators hypothesize a 25% reduction in DBI among patients receiving the MMSH bundle.
Specific Aim 3: Evaluate the barriers and facilitators of implementing a MMSH bundle across community and academic hospitals and assess compliance with various MMSH bundle components. Outcomes: The outcomes are the reasons and factors that either promote or hinder implementation of the MMSH bundle. The investigators will also measure proportional compliance with each MMSH bundle component across the entire period implementation for all clusters (units).
Exploratory Aim: Compare sleep quality, as monitored by actigraphy, between patients receiving the MMSH bundle in addition to the SOC-DSPP with that of those who were managed under the SOC-DSPP only. Outcome: The outcomes are sleep duration, and frequency of awakenings during the hours of 10:00 pm and 5:00 am (i.e., Z-time) ,day to day variability and circadian rest-activity rhythm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-critically ill patients (≥70 years)
- •All sexes
- •All races and ethnicities
- •Admitted to the pre-specified clinical units which are part of the study
排除标准
- •(applied during analysis):
- •Patients with active alcohol or substance withdrawal.
- •Patients with acute psychiatric illness
- •Patients with initial admission to intensive care unit including requirement for mechanical ventilation.
- •Patients present on a unit at the time of unit randomization
研究组 & 干预措施
MMSH (Multi-Modal Sleep Hygiene) Bundle
We will implement an MMSH bundle, enhancing a previously reported sleep focused intervention, in order to increase quality/quantity of sleep during Z-time (i.e., 10pm to 5am) in our intervention units, subsequently mitigating the burden of delirium in hospitalized older adults. Our proposed intervention domains perfectly align with the expressed patient suggestions to improve patient experience. Sleep disruption issues were raised at similar rates across the age span suggesting our MMSH will positively impact patients of all ages, including those with lower risk of delirium. The intervention components are outlined below and a comparison to the current standard of care and the components that are relevant to the fidelity aspects of the study are highlighted in the table. The main focus of the sleep interventions will focus on Noise, Light, Staff-Patient Interactions, Daytime Activity and Medications.
干预措施: MMSH (Multi-Modal Sleep Hygiene) Bundle (Other)
Standard of Care
This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment
结局指标
主要结局
Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)
时间窗: From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years
Proportion of patients who develop HAD among those who did not have D-POA. D-POA is defined as 4AT positivity (at least one) during the first 48 hours of hospital admission. HAD is defined as 4AT positivity (at least one) after 48 hours of 4AT negatives.
Delirium Burden Index (DBI) among patients with either delirium present on admission or those who develop HAD
时间窗: From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years
Proportion of positive 4AT assessments (squared) among all 4AT assessments. Patient level metric of delirium burden. Scale free, non-zero number. \[(#4AT+)2 / #Total 4AT\]
Adherence to MMSH bundle components: Nighttime and Daytime
时间窗: Starting from the date of randomization till the date of termination of the study assessments will be made twice weekly for each unit, up to 5 years
Reported as frequency and proportion of patients among whom full implementation was possible. Frequency and proportion of adherence with individual bundle components.
Factors facilitating or impeding implementation of MMSH bundle
时间窗: From the date of randomization assessments made up to 5 years
Qualitative / thematic analysis of semi-structured focus groups with unit staff and PFAC stakeholders
次要结局
- Need for higher level of care(Date of admission to the date of discharge or death, which ever comes first, up to 5 years)
- Resolution of delirium present on admission (D-POA)(From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years)
- Delirium Assessment Positivity Rate(From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years)
- Length of Hospital Stay (days)(From the date of admission to the date of discharge or death, whichever comes first, up to 5 years)
- Delirium free days(From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years)
- In hospital mortality(Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years)
- Hospital discharge disposition(Date of admission to the date of discharge (for patients discharged alive), up to 5 years)
- In Hospital complications(Date of admission to the date of discharge or death, whichever comes first, up to 5 years)
- Duration of daytime sleeping via actigraphy (non Z-time sleeping)(Baseline to Year 5)
- Patient Experience(Baseline to Year 5)
- Mobilization/Daytime Activity(Date of admission to the date of discharge or death (which ever comes first), up to 5 years)
- Sleep Quality for Actigraphy Patients(From the date of enrollment to the date of discharge or death, which ever comes first, assessed daily (for the daily survey), and assessed once post-discharge (for the post-discharge survey), up to 5 years)
- Sleep quality for all enrolled patients(Date of admission to the date of discharge, or death, whichever comes first, assessed every other day, up to 5 years.)
- Incidence rate of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (DPOA)(From the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years)
研究者
Farhaan S. Vahidy
Adjunct Professor of Neurosurgery
The Methodist Hospital Research Institute