Clinical trial NCT06736951: Modifying the Inpatient Environment to Reduce Delirium in Older Adults
Official title: Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Sleep Hygiene
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-17
Enrollment: 10890
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a step-wedge cluster randomized controlled trials in which hospital units will cross over from control to intervention phase in a randomly assigned sequence.
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)
timeFrame: 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
measure: Delirium Burden Index (DBI) among patients with either delirium present on admission or those who develop HAD
timeFrame: 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
measure: Adherence to MMSH bundle components: Nighttime and Daytime
timeFrame: 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
measure: Factors facilitating or impeding implementation of MMSH bundle
timeFrame: From the date of randomization assessments made up to 5 years
Secondary outcomes:
measure: Resolution of delirium present on admission (D-POA)
timeFrame: 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
measure: Delirium Assessment Positivity Rate
timeFrame: 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
measure: Length of Hospital Stay (days)
timeFrame: From the date of admission to the date of discharge or death, whichever comes first, up to 5 years
measure: Delirium free days
timeFrame: 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
measure: In hospital mortality
timeFrame: Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years
measure: Hospital discharge disposition
timeFrame: Date of admission to the date of discharge (for patients discharged alive), up to 5 years
measure: In Hospital complications
timeFrame: Date of admission to the date of discharge or death, whichever comes first, up to 5 years
measure: Need for higher level of care
timeFrame: Date of admission to the date of discharge or death, which ever comes first, up to 5 years
measure: Duration of daytime sleeping via actigraphy (non Z-time sleeping)
timeFrame: Baseline to Year 5
measure: Patient Experience
timeFrame: Baseline to Year 5
measure: Mobilization/Daytime Activity
timeFrame: Date of admission to the date of discharge or death (which ever comes first), up to 5 years
measure: Sleep Quality for Actigraphy Patients
timeFrame: 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
measure: Sleep quality for all enrolled patients
timeFrame: Date of admission to the date of discharge, or death, whichever comes first, assessed every other day, up to 5 years.
measure: Incidence rate of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (DPOA)
timeFrame: 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
Other outcomes:
measure: Duration of nighttime (10:00 pm to 5:00 am - 'Z-time') sleep time
timeFrame: Baseline to Year 5
measure: Frequency of nocturnal (10:00 pm to 5:00 am - 'Z-time') awakenings
timeFrame: Baseline to Year 5
Locations:
city: Baytown
country: United States
facility: Houston Methodist Baytown Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Houston
country: United States
facility: Houston Methodist West Hospital
state: Texas
city: Sugarland
country: United States
facility: Houston Methodist Sugarland Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Farhaan Vahidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.