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

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

Interventions

COMBINATION_PRODUCT

SMART HOME strategy

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%).

COMBINATION_PRODUCT

PADIS nursing intervention

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

Sponsors & Collaborators

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Pei-Yin Hsieh, MSN · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2024-12-31

Completion

2024-12-31