Modifying the Inpatient Environment to Reduce Delirium in Older Adults
This study is looking at ways to reduce delirium (a sudden state of confusion) in older adults (age 70 and above) who are in the hospital. Researchers are testing a "Multi-Modal Sleep Hygiene (MMSH) Bundle." This bundle includes changes to the hospital environment like reducing noise and light at night, increasing light during the day, and adjusting staff interactions to improve sleep. The goal is to see if these changes can lower the number of people who get delirium while in the hospital, or reduce how severe it is for those who already have it. You might be able to join if you are 70 or older, not critically ill, and admitted to certain hospital units. The study is currently unclear on its recruitment status, but plans to enroll 10,890 participants.
- Study design
- This is an interventional study with a planned enrollment of 10,890 participants. It uses a randomized step-wedge cluster design across 11 nursing units.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your delirium status and burden will be assessed every 12 hours from admission until discharge or death, for up to 5 years. Adherence to the MMSH bundle will be assessed twice weekly for each unit, for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Modifying the Inpatient Environment to Reduce Delirium in Older Adults
At a glance
Conditions
Where it's being run
5 sites across 1 statesStudy leadership
- Farhaan Vahidy, PhD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence (cumulative or proportion) of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (D-POA)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
Proportion of patients who develop HAD among those who did not have D-POA. D-POA is defined as 4AT positivity (at least one) during the first 48 hours of hospital admission. HAD is defined as 4AT positivity (at least one) after 48 hours of 4AT negatives.
- Delirium Burden Index (DBI) among patients with either delirium present on admission or those who develop HADFrom 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
Proportion of positive 4AT assessments (squared) among all 4AT assessments. Patient level metric of delirium burden. Scale free, non-zero number. \[(#4AT+)2 / #Total 4AT\]
- Adherence to MMSH bundle components: Nighttime and DaytimeStarting 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
Reported as frequency and proportion of patients among whom full implementation was possible. Frequency and proportion of adherence with individual bundle components.
- Factors facilitating or impeding implementation of MMSH bundleFrom the date of randomization assessments made up to 5 years
Qualitative / thematic analysis of semi-structured focus groups with unit staff and PFAC stakeholders