Modifying the Inpatient Environment to Reduce Delirium in Older Adults

December 11, 2024 updated by: Farhaan S. Vahidy

Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).

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%.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10890

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Houston Methodist Baytown Hospital
        • Contact:
        • Contact:
          • Farhaan Vahidy, PhD
        • Contact:
          • George Taffet, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Contact:
          • Farhaan Vahidy, PhD
        • Contact:
          • George Taffet, MD
      • Houston, Texas, United States, 77094
        • Recruiting
        • Houston Methodist West Hospital
        • Contact:
        • Contact:
          • Farhaan Vahidy, PhD
        • Contact:
          • George Taffet, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Contact:
        • Contact:
          • Farhaan Vahidy, PhD
        • Contact:
          • George Taffet, MD
      • Sugarland, Texas, United States, 77479
        • Recruiting
        • Houston Methodist Sugarland Hospital
        • Contact:
        • Contact:
          • Farhaan Vahidy, PhD
        • Contact:
          • George Taffet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
No Intervention: Standard of Care
This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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]
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
Reported as frequency and proportion of patients among whom full implementation was possible. Frequency and proportion of adherence with individual bundle components.
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
Qualitative / thematic analysis of semi-structured focus groups with unit staff and PFAC stakeholders
From the date of randomization assessments made up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Patient level indicator for the proportion of positive 4AT screen to the total number of 4AT screens for both D-POA and HAD patients
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
Median (interquartile range) for number of days of hospitalization, compared between intervention and SOC patients
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
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).
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
Proportion of patients experiencing in hospital mortality for intervention vs the SOC groups
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
Favorable discharge disposition (home or rehab) vs. unfavorable disposition (SNF, LTAC, Nursing Home)
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
Pre-defined set of in-hospital complications (pneumonia, sepsis, UTI, DVT) will be tracked.
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
Need for higher acuity care
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
Analysis of actigraphy data. Non - Z time sleep duration
Baseline to Year 5
Patient Experience
Time Frame: 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?"
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
Mobility Dashboard data of Percentage of Patient Days per unit with Any Activity Documented in patients aged 70 or greater on the intervention unit
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
Daily sleep quality survey and post-discharge sleep quality survey
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
Time Frame: 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)
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)
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
Number of new cases of delirium (among those who were non-D-POA) per person-time.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of nighttime (10:00 pm to 5:00 am - 'Z-time') sleep time
Time Frame: Baseline to Year 5
Analysis of actigraphy data.
Baseline to Year 5
Frequency of nocturnal (10:00 pm to 5:00 am - 'Z-time') awakenings
Time Frame: Baseline to Year 5
Analysis of actigraphy data.
Baseline to Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farhaan S. Vahidy

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Farhaan Vahidy, PhD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 1, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00037893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share IPD is undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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