Modifying the Inpatient Environment to Reduce Delirium in Older Adults

Not Applicable

Recruiting

• Conditions: Delirium; Sleep Hygiene

• Registration Number: NCT06736951
• Lead Sponsor: Farhaan S. Vahidy

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.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-09-01
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10890

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have 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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
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	Proportion of D-POA patients who resolve delirium. Defined as no positive 4AT screens following 48-hours of hospitalization among those who were positive during first 48 hours
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	Patient level indicator for the proportion of positive 4AT screen to the total number of 4AT screens for both D-POA and HAD patients
Length of Hospital Stay (days)	From the date of admission to the date of discharge or death, whichever comes first, up to 5 years	Median (interquartile range) for number of days of hospitalization, compared between intervention and SOC patients
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	Among patients with either incident delirium or delirium present on admission, the number of days (24 hours periods) which were free of delirium (all negative 4AT screens).
In hospital mortality	Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years	Proportion of patients experiencing in hospital mortality for intervention vs the SOC groups
Hospital discharge disposition	Date of admission to the date of discharge (for patients discharged alive), up to 5 years	Favorable discharge disposition (home or rehab) vs. unfavorable disposition (SNF, LTAC, Nursing Home)
In Hospital complications	Date of admission to the date of discharge or death, whichever comes first, up to 5 years	Pre-defined set of in-hospital complications (pneumonia, sepsis, UTI, DVT) will be tracked.
Need for higher level of care	Date of admission to the date of discharge or death, which ever comes first, up to 5 years	Need for higher acuity care
Duration of daytime sleeping via actigraphy (non Z-time sleeping)	Baseline to Year 5	Analysis of actigraphy data. Non - Z time sleep duration
Patient Experience	Baseline to Year 5	HCAHPS scores in patients aged 65 and older by unit preintervention versus post intervention. The question used will be: "During this hospital stay, how often was the area around your room quiet at night?"
Mobilization/Daytime Activity	Date of admission to the date of discharge or death (which ever comes first), up to 5 years	Mobility Dashboard data of Percentage of Patient Days per unit with Any Activity Documented in patients aged 70 or greater on the intervention unit
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	Daily sleep quality survey and post-discharge sleep quality survey
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.	Alternate day sleep quality survey for all enrolled patients (excluding actigraphy patients)
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	Number of new cases of delirium (among those who were non-D-POA) per person-time.

Trial Locations

Locations (5)

Houston Methodist Baytown Hospital; 🇺🇸 Baytown, Texas, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

Houston Methodist West Hospital; 🇺🇸 Houston, Texas, United States

Houston Methodist Sugarland Hospital; 🇺🇸 Sugarland, Texas, United States