Modifying the Inpatient Environment to Reduce Delirium in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MMSH (Multi-Modal Sleep Hygiene) Bundle.
- Who it may be relevant to
- Registry conditions: Delirium, Sleep Hygiene. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
Overview
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%.
Detailed description
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.
Interventions
- Other MMSH (Multi-Modal Sleep Hygiene) Bundle
Focus on Noise Reduce Noise Perception, Reduce Hallway Noise, Reduce Noise in Rooms Focus on Light Reduce Lights at Night, Increase Light in Day, Reduce Light Perception Focus on Staff-Patient Interactions Delirium Screening, Avoid Care Procedures at Night, Z-time Plan \& Prep Focus on Daytime Activity Increased Mobility, Increase Patient Engagement Focus on Medications Pain Management, Medication Monitoring, Continue pharmacy protocols, Timing of Medications/Monitoring Labs
Primary outcome measures
- Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA) [Time frame: 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 Burden Index (DBI) among patients with either delirium present on admission or those who develop HAD [Time frame: 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]
- Adherence to MMSH bundle components: Nighttime and Daytime [Time frame: 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]
- Factors facilitating or impeding implementation of MMSH bundle [Time frame: From the date of randomization assessments made up to 5 years]
Secondary outcome measures (12)
- Resolution of delirium present on admission (D-POA) [Time frame: 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 [Time frame: 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) [Time frame: From the date of admission to the date of discharge or death, whichever comes first, up to 5 years]
- Delirium free days [Time frame: 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 [Time frame: Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years]
- Hospital discharge disposition [Time frame: Date of admission to the date of discharge (for patients discharged alive), up to 5 years]
- In Hospital complications [Time frame: Date of admission to the date of discharge or death, whichever comes first, up to 5 years]
- Need for higher level of care [Time frame: Date of admission to the date of discharge or death, which ever comes first, up to 5 years]
- Duration of daytime sleeping via actigraphy (non Z-time sleeping) [Time frame: Baseline to Year 5]
- Patient Experience [Time frame: Baseline to Year 5]
- Mobilization/Daytime Activity [Time frame: Date of admission to the date of discharge or death (which ever comes first), up to 5 years]
- Sleep Quality for Actigraphy Patients [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 5 centers
- Houston Methodist Baytown Hospital — Baytown
- Houston Methodist Hospital — Houston
- Houston Methodist Research Institute — Houston
- Houston Methodist West Hospital — Houston
- Houston Methodist Sugarland Hospital — Sugarland
Publications
- Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638. PMID 24813132
Identifiers
NCT: NCT06736951 · PRO00037893