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NCT Number: NCT06736951

Modifying the Inpatient Environment to Reduce Delirium in Older Adults

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%.

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Key information

Conditions

Delirium Behavior Confusion Health Behavior Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Hygiene

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Baytown Hospital, Baytown, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMSH (Multi-Modal Sleep Hygiene) Bundle

Other

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 outcomes

  1. 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.

  2. 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]

  3. 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.

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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).

  5. 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

  6. 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)

  7. 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.

  8. 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

  9. 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

  10. 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?"

  11. 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

  12. 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

  13. 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)

  14. 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.

Other outcomes

  1. Duration of nighttime (10:00 pm to 5:00 am - 'Z-time') sleep time

    Time frame: Baseline to Year 5

    Analysis of actigraphy data.

  2. Frequency of nocturnal (10:00 pm to 5:00 am - 'Z-time') awakenings

    Time frame: Baseline to Year 5

    Analysis of actigraphy data.

Study contacts

Contact information is provided by the study sponsor or research team.

Rejani Nair, BSN

CONTACT

[email protected]

346-356-1496

Sponsors and collaborators

Lead sponsor

Farhaan S. Vahidy

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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