An interventional study of Multicomponent Delirium Prevention Bundle and Control Group in Delirium in Old Age, Delirium in the Intensive Care Unit and Delirium Confusional State, sponsored by Tel Aviv Medical Center. Active, not recruiting at 1 site in Israel. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Tel Aviv Medical Center · Not applicable, Interventional, and Prevention
The goal of this randomized controlled clinical trial is to learn whether a structured delirium prevention protocol can reduce the occurrence of delirium in older adults admitted to the cardiac intensive care unit (CICU). The study will include participants aged 70 years and older who are hospitalized in the CICU with acute cardiac conditions. The main questions it aims to answer are:
Does a structured non-pharmacologic delirium prevention protocol lower the incidence of delirium compared with usual care in older CICU patients? Does this protocol improve short- and long-term clinical outcomes, such as major adverse cardiac events (MACE), functional decline, and cognitive impairment? Researchers will compare participants randomly assigned to receive the delirium prevention protocol (intervention group) with participants receiving usual CICU care (control group) to see if the protocol leads to fewer episodes of delirium and better clinical and functional outcomes.
Participants will:
Be randomly assigned to the intervention group or the control group. Undergo daily delirium screening using the CAM-ICU tool. Be evaluated by an independent geriatrician who is not the principal investigator, and who will perform all clinical and geriatric assessments external to the treating CICU team.
In the intervention group, receive a structured prevention protocol that includes: daily pain assessment using the VAS scale and age-appropriate analgesia as needed, avoiding benzodiazepines when possible, use of earplugs and eye masks at night, early mobilization including bedside cycling exercises, and support for vision and hearing (use of glasses and hearing aids) and family presence overnight.
In the control group, receive usual CICU care, including delirium screening with CAM-ICU according to unit practice.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 200 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Tel Aviv Medical Center is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Compared within Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Confusion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the intervention arm, patients will receive the full delirium-prevention bundle.
Other: Multicomponent Delirium Prevention Bundle
This group will receive the current standard of care provided in the CICU. Current delirium management in the CICU is limited, and there is no standardized protocol for delirium management.
Other: Control Group
Patients will undergo daily assessment with CAM-ICU by a geriatrician participating in the study, who is not part of the CICU treating team or the principal investigator group. Patients will undergo daily pain assessment using the Visual Analog Scale (VAS). Analgesia will be administered as needed according to the CICU established delirium protocol. Hypnotic medications will be administered only to patients with an established home regimen of such medications; in patients without a pre-existing home regimen, benzodiazepine administration will be avoided. Use of earplugs to minimize background noise; Eye masks during nighttime hours; Encouraging family presence overnight; Ensuring the use of sensory aids (glasses and hearing aids). Implementation of an early mobilization. Reorientation will be provided by the nursing staff every eight hours. Follow-up at the cardio-geriatric clinic within 6 months, including a comprehensive cardiac evaluation and provide recommendations for management.
Patients will undergo daily assessment with CAM-ICU by a geriatrician participating in the study, who is not part of the CICU treating team or the principal investigator group. During the study, there will be no restriction on any components considered standard of care. Follow-up at the cardio-geriatric clinic within 6 months, including a comprehensive cardiac evaluation and provide recommendations for management.
Number of Participants Who Develop Delirium During Cardiac Intensive Care Unit Stay
Delirium will be assessed once daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), from admission to the cardiac intensive care unit through discharge from the unit. Delirium will be defined as at least one positive CAM-ICU assessment during the cardiac intensive care unit stay.
Time frame: From admission to the cardiac intensive care unit through discharge from the cardiac intensive care unit
MACE
major adverse cardiac event: nonfatal stroke, nonfatal MI, cardiovascular death
Time frame: From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months).
Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up
Functional status will be assessed using the Katz Index of Independence in Activities of Daily Living. The total score ranges from 0 to 6, with higher scores indicating greater independence in activities of daily living. Functional decline will be defined as a decrease of at least 1 point from the baseline score to the post-hospital follow-up assessment.
Time frame: Baseline and 6 months after hospital discharge
Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Cognitive performance will be compared between the baseline assessment and the post-hospital follow-up assessment.
Time frame: Baseline and 6 months after hospital discharge
Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up
Frailty will be assessed using the Clinical Frailty Scale. The Clinical Frailty Scale ranges from 1 to 9, with higher scores indicating greater frailty. Change in Clinical Frailty Scale score will be assessed by comparing the baseline assessment with the post-hospital follow-up assessment.
Time frame: Baseline and 6 months after hospital discharge
Number of Participants With Adverse Events Related to Antipsychotic Medication Use
Adverse events occurring after administration of antipsychotic medication will be assessed through clinical evaluation, electrocardiographic monitoring, laboratory results, and review of medical records. Events considered related to antipsychotic medication by the study investigator will be recorded. A participant will be counted once if one or more adverse events related to antipsychotic medication occur during the assessment period.
Time frame: From first administration of antipsychotic medication through discharge from the cardiac intensive care unit
Change in Barthel Index Score From Baseline to Post-Hospital Follow-up
Functional status will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living. Functional decline will be defined as a decrease of at least 10 points from the baseline score to the post-hospital follow-up assessment.
Time frame: Baseline and 6 months after hospital discharge
Plan to share: No — Individual participant data will not be made available to other researchers because of privacy and confidentiality considerations and the absence of a formal data-sharing agreement.
Started Jun 2026 (actual). Primary completion is estimated for Sep 2027, 15 months after the start.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 15 months is below that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Tel Aviv Medical Center