Modifying the Inpatient Environment to Reduce Delirium in Older Adults

NCT06736951 | Recruiting DMC

• 1 other identifier: PRO00037893
• Study Type: interventional
• Target: 10,890
• Locations: 1 country
• Sites: 5

Brief Summary

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%.

Conditions

Delirium; Sleep Hygiene

Outcome Measures

Primary Outcomes (4)

• 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.

  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. \[(#4AT+)2 / #Total 4AT\]

  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.

  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

  From the date of randomization assessments made up to 5 years

Secondary Outcomes (14)

• Resolution of 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

• Delirium Assessment Positivity Rate

  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)

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

• Delirium free days

  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

• In hospital mortality

  Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years

Other Outcomes (2)

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

  Baseline to Year 5

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

  Baseline to Year 5

Study Arms (2)

MMSH (Multi-Modal Sleep Hygiene) Bundle

EXPERIMENTAL

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.

Other: MMSH (Multi-Modal Sleep Hygiene) Bundle

Standard of Care

NO INTERVENTION

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

Interventions

MMSH (Multi-Modal Sleep Hygiene) Bundle OTHER

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

MMSH (Multi-Modal Sleep Hygiene) Bundle

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farhaan S. Vahidy: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Houston Methodist Baytown Hospital

Baytown, Texas, 77521, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist West Hospital

Houston, Texas, 77094, United States

RECRUITING

Houston Methodist Sugarland Hospital

Sugarland, Texas, 77479, United States

RECRUITING

Related Publications (1)

• Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638.

  PMID: 24813132 BACKGROUND

Related Links

• PCORI Webpage for Study

MeSH Terms

Conditions

Delirium; Sleep Hygiene

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Farhaan Vahidy, PhD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rejani Nair, BSN

CONTACT

346-356-1496; rrnair@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Professor of Neurosurgery

Model Details: This is a step-wedge cluster randomized controlled trials in which hospital units will cross over from control to intervention phase in a randomly assigned sequence.

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: December 17, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (5)