Recruiting

Multi-Modal Sleep Hygiene

Sponsor:

Farhaan S. Vahidy

Code:

NCT06736951

Conditions

Delirium

Sleep Hygiene

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

MMSH (Multi-Modal Sleep Hygiene) Bundle

Study Details

Brief summary:

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%.

Conditions

Delirium

Sleep Hygiene

Study ID

NCT06736951

Start date

Jun 1, 2024

Status verified date

Dec, 2024

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10890 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

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

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 ]
  • 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 ]
  • 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 ]
  • Factors facilitating or impeding implementation of MMSH bundle [ Time Frame: From the date of randomization assessments made up to 5 years ]

Central Contacts and Locations

Central contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

Locations

Houston Methodist Baytown Hospital

Recruiting

Baytown, Texas, United States, 77521

Contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

Houston Methodist West Hospital

Recruiting

Houston, Texas, United States, 77094

Contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

Houston Methodist Sugarland Hospital

Recruiting

Sugarland, Texas, United States, 77479

Contacts

Rejani Nair, BSN

346-356-1496rrnair@houstonmethodist.org

More Information

Sponsor

Farhaan S. Vahidy

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Farhaan S. Vahidy on 2024-12-17.