Using SMART HOME Strategy to Reduce the Incidence of Delirium in the Intensive Care Unit

NCT06030453 | Unknown

• 1 other identifier: 202307034RIND
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Delirium not only has a high incidence rate among hospitalized patients but also increases mortality rates, causes distress to patients and their families, and adds to healthcare costs. Studies have shown that non-pharmacological preventive measures can effectively prevent delirium. However, critically ill patients with multiple tubes and devices cannot receive home care due to their unstable condition. Therefore, this study aims to design multiple measures resembling a home environment in the hospital ICU to reduce the incidence of delirium. Objectives: Primary outcomes:the incidence and duration of delirium.Secondary outcomes :hospital stay, mortality rates, and patient or family satisfaction. Methods and Procedures: A prospective randomized double-blind study design. The study is planned to be conduct from January 1,2024 to December 30,2024。 Prior to enrollment, informed consent forms will be obtained and patients from six ICUs in the hospital. Inclusion criteria: Adult patients aged 18 or above. No maximum age limit. Patients with a Richmond Agitation-Sedation Scale score ranging from -3 to +4.Exclusion criteria: Patients with an existing diagnosis of delirium. Patients who were unable to communicate(GCS≦3）。 Patients with moderate to severe dementia.Patients with severe sedation or coma(GCS≦3）。 Sample Size: The control group's delirium incidence rate of 69.1% based on a study. The experimental group is expected to reduce delirium incidence rate to 40%。 A α value of 0.05, power 80%, each group will require 45 participants, total sample size 90 participants.A loss to follow-up rate about 15%。 To improve the effectiveness of the research design results, sample size is increased to 104 and each group is 52 participants. Intervention Design:Each delirium assessment using the ICDSC, both groups will undergo routine assessment using RASS. Control Group: Receive traditional comprehensive care in the ICU based on the PADIS assessment. This care will be administered by ICU nurses and will include pharmacological treatments as well as nursing interventions. Experimental Group: ICDSC along with PRE-DELIRIC model. Intervention: In addition to the routine comprehensive care provided in the ICU, the experimental group will receive SMART HOME care interventions. Outcome measures :ICDSC,PRE-DELIRIC,Incidence of Delirium,Duration of Delirium,LOS,Mortality Rate,Satisfaction.

Conditions

Delirium; Intensive Care Unit Delirium

Keywords

The incidence of delirium; The intensive care unit.

Outcome Measures

Primary Outcomes (2)

• The incidence of delirium.

  Incidence of Delirium: Refers to the proportion of new cases of delirium occurring in the study population after admission to the ICU (assessed using intensive care delirium screening checklist , with a score \>4 point indicating delirium). It is expressed as a percentage %.

  From date of randomization until the date of first documented of delirium date or delirium ended date, assessed up to 6 months.

• The duration of delirium

  Duration of delirium:Refers to the time from the onset to the end of delirium in the study population after admission to the ICU. The duration can be in hours, days, or longer,Like 5 hours or 7days.

  From date of randomization until the date of first documented of delirium date or delirium ended date, assessed up to 6 months.

Secondary Outcomes (3)

• Length of Stay

  From date of randomization until the date of first documented of discharge or date transfer out of ICU or date of death from any cause, whichever came first, assessed up to 6 months.

• mortality rates

  From date of randomization until the date of first documented of discharge or date transfer out of ICU or date of death from any cause, whichever came first, assessed up to 6 months.

• patient or family satisfaction

  From date of randomization until the date of first documented of discharge or date transfer out of ICU or date of death from any cause, whichever came first, assessed up to 6 months.

Study Arms (2)

SMART HOME Care Gruop

EXPERIMENTAL

Experimental Group:"SMART HOME" refers to a set of interventions aimed at preventing delirium. Sleep hygiene.Multidisciplinary collaboration.Assessment of pain/anxiety/agitation.Release of tracheal tubes and restraints.Time and schedule.Home-like environment and Hearing.Orientation support.Medication review and adjustment.Early mobilization and nutrition.

Combination Product: SMART HOME strategy

Control Group

ACTIVE COMPARATOR

Control Group: The control group will receive traditional comprehensive care in the ICU based on the PADIS (pain, agitation, delirium, immobility, sleep disruption) assessment. This care will be administered by ICU nurses and will include pharmacological treatments for pain, agitation, delirium, immobility, and sleep disruption as well as nursing interventions.

Combination Product: PADIS nursing intervention

Interventions

SMART HOME strategy COMBINATION_PRODUCT

Sleep hygiene: quiet and dim environment for 6 hours to facilitate sleep (Score: 0-100%).Multidisciplinary collaboration: pharmacists, respiratory therapists, rehabilitation therapists, and physical therapists (Score: ≥20%).Assessment : Evaluating and assessing the levels of pain, anxiety, and agitation (Score: 0-100%).Release of tracheal tubes and restraints: relieving pressure from tracheal tubes and restraints (Score: 0-100%).Time and schedule: Orienting the patient to time and a schedule (Score: 0-100%).Home-like environment and Hearing: A comfortable environment similar to home and music (Score: 0-100%).Orientation support: assisting with a sense of person, time, and place (Score: 0-100%).Medication review : Reviewing and adjusting medications (Score: ≥20%).Early mobilization and nutrition(Score: 0-100%).

SMART HOME Care Gruop

PADIS nursing intervention COMBINATION_PRODUCT

pharmacological treatments for pain, agitation, delirium, immobility, and sleep disruption as well as nursing interventions

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate sedation to Combative (Richmond Agitation-Sedation Scale score : -3 to +4)

You may not qualify if:

• Delirium. GCS≦3. Moderate to severe dementia.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Yin Hsieh, MSN

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Yin Hsieh, MSN

CONTACT

886-2-23123456; peiyin3111@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 11, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-08