Modifying the Inpatient Environment to Reduce Delirium in Older Adults

Farhaan S. Vahidy

Status: Enrolling

Conditions: Delirium; Sleep Hygiene

Treatments: Other: MMSH (Multi-Modal Sleep Hygiene) Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT06736951

PRO00037893

Details and patient eligibility

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. 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%.

Full description

The Investigators will implement the MMSH in a randomized step-wedge cluster design across 11 independent nursing units of 4 Methodist hospitals. While primarily focusing on the MMSH effectiveness, the investigators will conduct process evaluation to identify barriers and facilitators for MMSH implementation.

Specific Aim 1: Establish the comparative effectiveness of an in-hospital, MMSH towards reducing the rate of incident (hospital acquired) delirium (HAD) among older adults (age ≥ 70). The investigators will compare the rate of incident delirium between patients receiving the MMSH bundle in addition to the Standard of Care delirium screening and prevention protocol (SOC-DSPP), and those who are managed only under the SOC-DSPP. The SOC-DSPP through out all HM units includes twice daily deliruim screening with the 4AI. Outcome: The primary outcome is incident delirium (or HAD), determined by a positive 4AT, among patients who did not have delirium present on admission. The investigators hypothesize a 33% reduction in incident delirium among patients receiving the MMSH bundle.

Specific Aim 2: Establish the comparative effectiveness of an in-hospital, MMSH towards reducing delirium burden, as measured by DBI, among older adults (age ≥ 70), either with HAD or with D-POA. The investigators will compare the DBI between patients receiving the MMSH bundle in addition to the SOC-DSPP with that of those who were managed only under the SOC-DSPP. Outcome: The primary outcome is patient-level DBI [(number of positive 4AT screens)2/total number of 4AT screens)]. The DBI will be a non-zero positive fraction which is scale free because it accounts for the duration of observation by taking into consideration the total number of delirium assessments. Investigators hypothesize a 25% reduction in DBI among patients receiving the MMSH bundle.

Specific Aim 3: Evaluate the barriers and facilitators of implementing a MMSH bundle across community and academic hospitals and assess compliance with various MMSH bundle components. Outcomes: The outcomes are the reasons and factors that either promote or hinder implementation of the MMSH bundle. The investigators will also measure proportional compliance with each MMSH bundle component across the entire period implementation for all clusters (units).

Exploratory Aim: Compare sleep quality, as monitored by actigraphy, between patients receiving the MMSH bundle in addition to the SOC-DSPP with that of those who were managed under the SOC-DSPP only. Outcome: The outcomes are sleep duration, and frequency of awakenings during the hours of 10:00 pm and 5:00 am (i.e., Z-time) ,day to day variability and circadian rest-activity rhythm.

Enrollment: 10,890 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10,890 participants in 2 patient groups

MMSH (Multi-Modal Sleep Hygiene) Bundle

Experimental group

Description:

We will implement an MMSH bundle, enhancing a previously reported sleep focused intervention, in order to increase quality/quantity of sleep during Z-time (i.e., 10pm to 5am) in our intervention units, subsequently mitigating the burden of delirium in hospitalized older adults. Our proposed intervention domains perfectly align with the expressed patient suggestions to improve patient experience. Sleep disruption issues were raised at similar rates across the age span suggesting our MMSH will positively impact patients of all ages, including those with lower risk of delirium. The intervention components are outlined below and a comparison to the current standard of care and the components that are relevant to the fidelity aspects of the study are highlighted in the table. The main focus of the sleep interventions will focus on Noise, Light, Staff-Patient Interactions, Daytime Activity and Medications.

Treatment:

Other: MMSH (Multi-Modal Sleep Hygiene) Bundle

Standard of Care

No Intervention group

Description:

This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment