Modifying the Inpatient Environment to Reduce Delirium in Older Adults

ConditionsDelirium Sleep Hygiene

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age70+

SponsorFarhaan S. Vahidy

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

MMSH (Multi-Modal Sleep Hygiene) Bundle
Other intervention
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

Treatment groups

10,890 Participants

are divided into 2 treatment groups

Group A: MMSH (Multi-Modal Sleep Hygiene) BundleExperimental treatment 1 intervention

Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

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.

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

Delirium Burden Index (DBI) among patients with either delirium present on admission or those who develop HAD

Proportion of positive 4AT assessments (squared) among all 4AT assessments. Patient level metric of delirium burden. Scale free, non-zero number. \[(#4AT+)2 / #Total 4AT\]

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

Adherence to MMSH bundle components: Nighttime and Daytime

Reported as frequency and proportion of patients among whom full implementation was possible. Frequency and proportion of adherence with individual bundle components.

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

Factors facilitating or impeding implementation of MMSH bundle

Qualitative / thematic analysis of semi-structured focus groups with unit staff and PFAC stakeholders

Time frame

From the date of randomization assessments made up to 5 years

Secondary outcomes

Resolution of delirium present on admission (D-POA)

Proportion of D-POA patients who resolve delirium. Defined as no positive 4AT screens following 48-hours of hospitalization among those who were positive during first 48 hours

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

Delirium Assessment Positivity Rate

Patient level indicator for the proportion of positive 4AT screen to the total number of 4AT screens for both D-POA and HAD patients

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

Length of Hospital Stay (days)

Median (interquartile range) for number of days of hospitalization, compared between intervention and SOC patients

Time frame

From the date of admission to the date of discharge or death, whichever comes first, up to 5 years

Delirium free days

Among patients with either incident delirium or delirium present on admission, the number of days (24 hours periods) which were free of delirium (all negative 4AT screens).

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

Other outcomes

Duration of nighttime (10:00 pm to 5:00 am - 'Z-time') sleep time

Analysis of actigraphy data.

Time frame

Baseline to Year 5

Frequency of nocturnal (10:00 pm to 5:00 am - 'Z-time') awakenings

Analysis of actigraphy data.

Time frame

Baseline to Year 5

Sponsors and contacts

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Farhaan S. Vahidy

Lead sponsor

The Methodist Hospital Research Institute

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

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