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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

DeliriumSleep Hygiene

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Dec 17, 2024 · Source of record for eligibility and locations

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1 of 10890 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Baytown

Texas

Location available
RECRUITING

Houston

Texas

Location available
RECRUITING

Houston

Texas

Location available
RECRUITING

Houston

Texas

Location available
RECRUITING

Sugarland

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Looking for Delirium Treatment in Baytown?

Join others in Texas exploring innovative treatment options through clinical research

Delirium Treatment Options in Baytown, Texas

If you're searching for Delirium treatment in Baytown, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Baytown, Houston, Sugarland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Delirium. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Texas
Now Enrolling
Up to 10890 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Delirium?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Delirium

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Delirium Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06736951. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.