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.

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NCT06736951

Modifying the Inpatient Environment to Reduce Delirium in Older Adults

Recruiting
NAAges 70+InterventionalPrevention
Farhaan S. Vahidy
~10,890 participants
Updated 2024-12-17 on ClinicalTrials.gov
What's tested:MMSH (Multi-Modal Sleep Hygiene) Bundle

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
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)
Measured over 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
+3 more outcomes measured
Delirium
Sleep Hygiene
5 sites across 1 states
Texas5
  • Farhaan Vahidy, PhD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

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Eligibility criteria

Inclusion

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

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
  • 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