RecruitingNot Applicable

Modifying the Inpatient Environment to Reduce Delirium in Older Adults

United States10,890 participantsStarted 2024-06-01

Plain-language 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%.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: From the date of randomization assessments made up to 5 years

Trial details

NCT IDNCT06736951

SponsorFarhaan S. Vahidy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

Rejani Nair, BSN

346-356-1496 rrnair@houstonmethodist.org

View on ClinicalTrials.gov More Delirium trials

Plain-language summary

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: From the date of randomization assessments made up to 5 years