Modifying the Inpatient Environment to Reduce Delirium in Older Adults

Part of paid clinical trials in Baytown, Texas.

Sponsor
Farhaan S. Vahidy
Study ID
NCT06736951
Status
Recruiting

Conditions

  • Delirium
  • Sleep Hygiene

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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%.

Key Dates

Start date
Jun 1, 2024
Status verified
Dec 2024
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
10,890 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.
  • No Intervention: Standard of Care
    This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment

Primary Outcome Measure

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Houston Methodist Baytown HospitalBaytownTexas77521
Rejani Nair, BSN
346-356-1496
Farhaan Vahidy, PhD
George Taffet, MD
Houston Methodist HospitalHoustonTexas77030
Rejani Nair, BSN
346-356-1496
Farhaan Vahidy, PhD
George Taffet, MD
Houston Methodist Research InstituteHoustonTexas77030
Rejani Nair, BSN
346-356-1496
Farhaan Vahidy, PhD
George Taffet, MD
Houston Methodist West HospitalHoustonTexas77094
Rejani Nair, BSN
346-356-1496
Farhaan Vahidy, PhD
George Taffet, MD
Houston Methodist Sugarland HospitalSugarlandTexas77479
Rejani Nair, BSN
346-356-1496
Farhaan Vahidy, PhD
George Taffet, MD

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