Acute Coronary Syndromes (ACS), Cardiac Intensive Care Unit, Delirium, Delirium Confusional State, Delirium in Old Age, Delirium in the Intensive Care Unit, Frailty in Older Adults
Conditions
Keywords
Delirium, cardiac intensive care unit, CICU, Acute coronary syndrome, Acute heart failure, Older adults, Frailty, Clinical Frailty Scale, Geriatric cardiology, Non-pharmacologic intervention, Delirium prevention, Early mobilization, CAM-ICU, MACE
Brief summary
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.
Interventions
OTHERMulticomponent Delirium Prevention Bundle
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.
OTHERControl 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. 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.
Sponsors
Tel Aviv Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study uses a parallel-group randomized controlled design with two arms: an intervention arm and a usual-care control arm. Participants aged 70 years and older admitted to the cardiac intensive care unit (CICU) are randomized 1:1 to receive either a structured delirium prevention protocol plus standard care or standard care alone. In the intervention arm, participants receive a multicomponent non-pharmacologic bundle that includes daily pain assessment with age-appropriate analgesia, avoidance of benzodiazepines when feasible, daily CAM-ICU screening, sleep and sensory optimization (earplugs, eye masks, support for glasses and hearing aids, family presence when possible), and early mobilization including in-bed cycling. All geriatric, frailty, functional and cognitive assessments, as well as outcome evaluations, are performed by an independent geriatrician who is external to the CICU team.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥70 years * Expected CICU length of stay \>24 hours * Willing to participate in the study
Exclusion criteria
* Age \<70 years * Delirium diagnosed prior to admission to the Cardiac Intensive Care Unit (CICU). * Diagnosis of delirium tremens * Diagnosis of advanced dementia * Terminal condition, with an anticipated life expectancy of less than 48 hours * Receiving invasive mechanical ventilation * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Delirium During Cardiac Intensive Care Unit Stay | From admission to the cardiac intensive care unit through discharge from the cardiac intensive care unit | 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. |
| MACE | From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months). | major adverse cardiac event: nonfatal stroke, nonfatal MI, cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up | Baseline and 6 months after hospital discharge | 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. |
| Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up | Baseline and 6 months after hospital discharge | 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. |
| Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up | Baseline and 6 months after hospital discharge | 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. |
| Number of Participants With Adverse Events Related to Antipsychotic Medication Use | From first administration of antipsychotic medication through discharge from the cardiac intensive care unit | 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. |
| Change in Barthel Index Score From Baseline to Post-Hospital Follow-up | Baseline and 6 months after hospital discharge | 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. |
Countries
Israel
Contacts
PRINCIPAL_INVESTIGATORKeren Lee Rozenfeld, MD
Department of Cardiology, Tel Aviv Sourasky Medical Center
PRINCIPAL_INVESTIGATORYishay Szekely, MD
Department of Cardiology, Tel Aviv Sourasky Medical Center
Outcome results
None listed