NCT06736951 · Farhaan S. Vahidy
Modifying the Inpatient Environment to Reduce Delirium in Older Adults
What this study is about
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.
View original scientific description
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%.
Interventions
OTHER
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 measures
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
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 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
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 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
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 bundle
Time frame: From the date of randomization assessments made up to 5 years
Qualitative / thematic analysis of semi-structured focus groups with unit staff and PFAC stakeholders
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Non-critically ill patients (≥70 years)
- 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
- Baytown, Texas
- Houston, Texas
- Sugarland, Texas
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Dec 17, 2024 · Source of record for eligibility and locations