Improving hospital environments to reduce delirium in older adults
Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
NA · The Methodist Hospital Research Institute · NCT06736951
This study is testing if improving the hospital environment to help older adults sleep better can reduce the chances of them developing delirium while they're hospitalized.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10890 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Locations | 5 sites (Baytown, Texas and 4 other locations) |
| Trial ID | NCT06736951 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce the incidence of delirium in hospitalized older adults (aged 70 and above) by modifying the inpatient environment to enhance sleep hygiene. The investigators will implement a multi-modal sleep hygiene (MMSH) bundle across 11 nursing units in four Methodist hospitals, comparing its effectiveness against standard delirium prevention protocols. The study will utilize a randomized step-wedge cluster design and will also evaluate the implementation process to identify barriers and facilitators. The primary outcomes include the rate of incident delirium and the delirium burden index among participants.
Who should consider this trial
Good fit: Ideal candidates for this study are non-critically ill patients aged 70 years and older who are admitted to the participating clinical units.
Not a fit: Patients with active alcohol or substance withdrawal, acute psychiatric illness, or those initially admitted to intensive care units will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of delirium in older hospitalized patients, improving their overall health outcomes and quality of care.
How similar studies have performed: Previous studies have shown success with similar sleep-focused interventions, indicating potential for this approach to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baytown, Texas and 4 other locations
- Houston Methodist Baytown Hospital — Baytown, Texas, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- Houston Methodist Research Institute — Houston, Texas, United States (RECRUITING)
- Houston Methodist West Hospital — Houston, Texas, United States (RECRUITING)
- Houston Methodist Sugarland Hospital — Sugarland, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Farhaan Vahidy, PhD — The Methodist Hospital Research Institute
- Study coordinator: Rejani Nair, BSN
- Email: rrnair@houstonmethodist.org
- Phone: 346-356-1496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delirium, Sleep Hygiene