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 — OTHERFocus 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) BundleWe 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 CareThis 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
- Rejani Nair, BSN346-356-1496
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Houston Methodist Baytown Hospital | Baytown | Texas | 77521 | Farhaan Vahidy, PhD George Taffet, MD |
| Houston Methodist Hospital | Houston | Texas | 77030 | Farhaan Vahidy, PhD George Taffet, MD |
| Houston Methodist Research Institute | Houston | Texas | 77030 | Farhaan Vahidy, PhD George Taffet, MD |
| Houston Methodist West Hospital | Houston | Texas | 77094 | Farhaan Vahidy, PhD George Taffet, MD |
| Houston Methodist Sugarland Hospital | Sugarland | Texas | 77479 | Farhaan Vahidy, PhD George Taffet, MD |
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