Using SMART HOME Strategy to Reduce the Incidence of Delirium in the Intensive Care Unit
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ClinicalTrials.gov Identifier: NCT06030453 |
Recruitment Status :
Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Delirium Intensive Care Unit Delirium | Combination Product: SMART HOME strategy Combination Product: PADIS nursing intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Using SMART HOME Strategy to Reduce the Incidence of Delirium in the Intensive Care Unit: A Randomized Controlled Study |
Estimated Study Start Date : | January 1, 2024 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
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Experimental: SMART HOME Care Gruop
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.
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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%). |
Active Comparator: Control Group
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.
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Combination Product: PADIS nursing intervention
pharmacological treatments for pain, agitation, delirium, immobility, and sleep disruption as well as nursing interventions |
- The incidence of delirium. [ Time Frame: From date of randomization until the date of first documented of delirium date or delirium ended date, assessed up to 6 months. ]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 %.
- The duration of delirium [ Time Frame: From date of randomization until the date of first documented of delirium date or delirium ended date, assessed up to 6 months. ]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.
- Length of Stay [ Time Frame: 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. ]Length of Stay: Refers to the total time the patients received treatment or observation in the hospital, measured in days.
- mortality rates [ Time Frame: 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 Rate: Refers to the proportion of deaths that occurred within the study population during the hospital stay, expressed as a percentage %.
- patient or family satisfaction [ Time Frame: 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: The overall satisfaction with the new multidisciplinary care measures was assessed using a Likert five-point scale, ranging from strongly disagree to strongly agree, with scores ranging from 1 to 5 point.1 point means very dissatisfied,5 points means very satisfied.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Moderate sedation to Combative (Richmond Agitation-Sedation Scale score : -3 to +4)
Exclusion Criteria:
Delirium. GCS≦3. Moderate to severe dementia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030453
Contact: Pei-Yin Hsieh, MSN | 886-2-23123456 ext 263083 | peiyin3111@ntuh.gov.tw |
Principal Investigator: | Pei-Yin Hsieh, MSN | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT06030453 |
Other Study ID Numbers: |
202307034RIND |
First Posted: | September 11, 2023 Key Record Dates |
Last Update Posted: | September 11, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
The incidence of delirium The intensive care unit. |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |