Modifying the Inpatient Environment to Reduce Delirium in Older Adults
NCT ID: NCT06736951
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10890 participants
INTERVENTIONAL
2024-06-01
2029-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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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.
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
Standard of Care
This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* All sexes
* All races and ethnicities
* Admitted to the pre-specified clinical units which are part of the study
Exclusion Criteria
* 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
70 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Farhaan S. Vahidy
OTHER
Responsible Party
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Farhaan S. Vahidy
Adjunct Professor of Neurosurgery
Principal Investigators
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Farhaan Vahidy, PhD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Rejani Nair, BSN
Role: primary
Farhaan Vahidy, PhD
Role: backup
George Taffet, MD
Role: backup
Rejani Nair, BSN
Role: primary
Farhaan Vahidy, PhD
Role: backup
George Taffet, MD
Role: backup
Rejani Nair, BSN
Role: primary
Farhaan Vahidy, PhD
Role: backup
George Taffet, MD
Role: backup
Rejani Nair, BSN
Role: primary
Farhaan Vahidy, PhD
Role: backup
George Taffet, MD
Role: backup
Rejani Nair, BSN
Role: primary
Farhaan Vahidy, PhD
Role: backup
George Taffet, MD
Role: backup
References
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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.
Related Links
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Other Identifiers
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PRO00037893
Identifier Type: -
Identifier Source: org_study_id