DeliriumNCT06736951
Modifying the Inpatient Environment to Reduce Delirium in Older Adults
A study testing MMSH (Multi-Modal Sleep Hygiene) Bundle in people with Delirium and Sleep Hygiene, run by Farhaan S. Vahidy at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium, Sleep Hygiene
- What is being tested?
- MMSH (Multi-Modal Sleep Hygiene) Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,890 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Houston Methodist Baytown Hospital
Baytown, Texas, 77521
Rejani Nair, BSN, 346-356-1496, rrnair@houstonmethodist.org
Farhaan Vahidy, PhD
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Rejani Nair, BSN, 346-356-1496, rrnair@houstonmethodist.org
Farhaan Vahidy, PhD
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Rejani Nair, BSN, 346-356-1496, rrnair@houstonmethodist.org
Farhaan Vahidy, PhD
- Recruiting
Houston Methodist West Hospital
Houston, Texas, 77094
Rejani Nair, BSN, 346-356-1496, rrnair@houstonmethodist.org
Farhaan Vahidy, PhD
- Recruiting
Houston Methodist Sugarland Hospital
Sugarland, Texas, 77479
Rejani Nair, BSN, 346-356-1496, rrnair@houstonmethodist.org
Farhaan Vahidy, PhD
About this study
Official title: Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
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%.
Read the detailed 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.
- Conditions
- Delirium, Sleep Hygiene
- Being tested
- MMSH (Multi-Modal Sleep Hygiene) Bundle
- Medical subject headings
- Delirium, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSH (Multi-Modal Sleep Hygiene) BundleOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Measured: 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.
Measured: 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
Measured: From the date of randomization assessments made up to 5 years
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Proportion of patients experiencing in hospital mortality for intervention vs the SOC groups
Measured: Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years
Hospital discharge disposition
Favorable discharge disposition (home or rehab) vs. unfavorable disposition (SNF, LTAC, Nursing Home)
Measured: Date of admission to the date of discharge (for patients discharged alive), up to 5 years
In Hospital complications
Pre-defined set of in-hospital complications (pneumonia, sepsis, UTI, DVT) will be tracked.
Measured: Date of admission to the date of discharge or death, whichever comes first, up to 5 years
Need for higher level of care
Need for higher acuity care
Measured: Date of admission to the date of discharge or death, which ever comes first, up to 5 years
Duration of daytime sleeping via actigraphy (non Z-time sleeping)
Analysis of actigraphy data. Non - Z time sleep duration
Measured: Baseline to Year 5
Patient Experience
HCAHPS scores in patients aged 65 and older by unit preintervention versus post intervention. The question used will be: "During this hospital stay, how often was the area around your room quiet at night?"
Measured: Baseline to Year 5
Mobilization/Daytime Activity
Mobility Dashboard data of Percentage of Patient Days per unit with Any Activity Documented in patients aged 70 or greater on the intervention unit
Measured: Date of admission to the date of discharge or death (which ever comes first), up to 5 years
Sleep Quality for Actigraphy Patients
Daily sleep quality survey and post-discharge sleep quality survey
Measured: From the date of enrollment to the date of discharge or death, which ever comes first, assessed daily (for the daily survey), and assessed once post-discharge (for the post-discharge survey), up to 5 years
Sleep quality for all enrolled patients
Alternate day sleep quality survey for all enrolled patients (excluding actigraphy patients)
Measured: Date of admission to the date of discharge, or death, whichever comes first, assessed every other day, up to 5 years.
Incidence rate of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (DPOA)
Number of new cases of delirium (among those who were non-D-POA) per person-time.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10,890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farhaan S. Vahidy
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Farhaan S. Vahidy, The Methodist Hospital Research Institute
- Investigators
- Farhaan Vahidy, PhD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736951
- Sponsor's protocol ID
- PRO00037893
- Status last verified
- Dec 2024
- First submitted
- 1 Sep 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD is undecided.
Publications
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.
PubMed 24813132
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying the Inpatient Environment to Reduce the Incidence and Burden of Delirium Among Hospitalized Older Adults (≥70 Years).
- ClinicalTrials.gov ID
- NCT06736951
- Acronym / sponsor ID
- PRO00037893
- Conditions
- Delirium, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,890 participants (estimated)
- Lead sponsor
- Farhaan S. VahidyUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MMSH (Multi-Modal Sleep Hygiene) Bundle | Experimental | Other: MMSH (Multi-Modal Sleep Hygiene) BundleWe 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. |
| Standard of Care | No intervention | –This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSH (Multi-Modal Sleep Hygiene) BundleFocus 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 | Other | MMSH (Multi-Modal Sleep Hygiene) Bundle |
Primary outcome
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
14 secondary outcomes
Resolution of 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
Delirium Assessment Positivity Rate
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)
Time frame: From the date of admission to the date of discharge or death, whichever comes first, up to 5 years
Delirium free days
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
In hospital mortality
Time frame: Date of admission to the date of discharge or the date of death, which ever comes first, up to 5 years
Hospital discharge disposition
Time frame: Date of admission to the date of discharge (for patients discharged alive), up to 5 years
In Hospital complications
Time frame: Date of admission to the date of discharge or death, whichever comes first, up to 5 years
Need for higher level of care
Time frame: Date of admission to the date of discharge or death, which ever comes first, up to 5 years
Duration of daytime sleeping via actigraphy (non Z-time sleeping)
Time frame: Baseline to Year 5
Patient Experience
Time frame: Baseline to Year 5
Mobilization/Daytime Activity
Time frame: Date of admission to the date of discharge or death (which ever comes first), up to 5 years
Sleep Quality for Actigraphy Patients
Time frame: From the date of enrollment to the date of discharge or death, which ever comes first, assessed daily (for the daily survey), and assessed once post-discharge (for the post-discharge survey), up to 5 years
Sleep quality for all enrolled patients
Time frame: Date of admission to the date of discharge, or death, whichever comes first, assessed every other day, up to 5 years.
Incidence rate of hospital acquired delirium (HAD) among patients who did not have delirium present on admission (DPOA)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 24813132Patel 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.
- PCORI Webpage for StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan to share IPD is undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farhaan Vahidy, PhD principal investigator
The Methodist Hospital Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMSH (Multi-Modal Sleep Hygiene) Bundle in people with Delirium and Sleep Hygiene, run by Farhaan S. Vahidy at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rejani Nair, BSN (346-356-1496, rrnair@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.