Pilot Study of Early Cognitive Training in the Intensive Care Unit (ECTICU)

The purpose of this study is to see how early cognitive training (participation/involvement in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of patients who experience delirium (confusion) and cognitive impairment (problems with thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of cognitive impairment: remembering, paying attention, solving problems, organizing, and working on complex tasks for some time after they leave the hospital.

Occupational therapy will do an assessment after an order is received from the doctor. The patient will be randomly placed into one of two groups. If the patient is in group A then they will continue with occupational therapy as normal. If the patient is assigned to group B then they and the family will have access to an activity cart found there in the ICU unit, directed by the nurses. The family will work with the patient on a daily basis to complete activities that are appropriate for the patient based on the occupational therapist's assessment. All patients in the study will receive medical care as usual.

Information about the patient's recovery in the hospital will be collected. In addition, patients and/or their family member will complete surveys at 6 months and 1 year after enrollment to see how they have recovered and if there are continuing issues. The two groups of patients, those who received the early cognitive training and those who did not, will be compared statistically to see if there are any differences in how well they recovered. Since this intervention involving family members working with the patient has not previously been evaluated, the study will also examine the feasibility of conducting these activities in the ICU setting.

Study Overview

• Status: Withdrawn
• Conditions: Intensive Care Units, Delirium, Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Early Cognitive Training

Detailed Description

This pilot study will assess the feasibility of implementing a randomized clinical trial testing an early cognitive training program for patients in the ICU. This cognitive training program was developed at Mount Carmel Health System in conjunction with occupational therapists and has not been previously evaluated.

Specific Aim 1: To evaluate whether the trial can accrue a sufficient number of patients within a reasonable time period to complete a randomized trial for efficacy.

Specific Aim 2: To evaluate whether the trial can be conducted as designed.

Specific Aim 3: To evaluate the likelihood that the trial can retain a sufficient number of patients through the end of follow-up.

Assessments include the Montreal Cognitive Assessment Test (MoCA), Richmond Agitation and Sedation Scale (RASS), Confusion Assessment Method in the ICU (CAM-ICU) and a validated quality of life survey.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient must be in the intensive care unit, i.e., either the surgical intensive care unit (SICU) or medical intensive care unit (MICU).
• Patient must be ≥18 years old.
• Predicted ICU length of stay greater than 3 days.
• Patient with a RASS goal of -1 to +1 at time of enrollment.
• Patient's family member(s) agree to do the cognitive training for a least one hour a day (a series of items meant to focus and stretch cognitive ability) while in the ICU. The hour can be done incrementally if needed. Family member should be ≥18 years old.
• Family who can return to the hospital at the 6 month mark to take a final MOCA test and complete a survey.

Exclusion Criteria:

• Patient presently on Versed, Diprivan or Ativan drips.
• Patient with a history of cognitive impairment, current psychiatric diagnosis and not stable on treatment, or developmental delay.
• Patient with Alzheimer's or dementia.
• Patient with known active substance abuse.
• Patients without family support.
• Patients without the ability to return to the hospital for the 6 month visit.
• Patient with history of critical care illness within the last year from time of enrollment.
• Patients who have been critically ill for greater than 72 hours.
• Non-English speaking individuals restricting ability to follow instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual medical care provided to patients in the ICU.
Experimental: Early Cognitive Training; Usual medical care provided to patients in the ICU plus additional activities designed to engage the patient's attention and cognition. Activities are chosen by the family member from an activity cart according to the level designated by occupation therapy.	Behavioral: Early Cognitive Training; Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Enrollment	Percent of eligible patients who are consented and enrolled into the study.	3 Days
Percent Receiving Intervention	Percent of patients randomized to intervention who receive intervention	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment Score	Change in Montreal Cognitive Assessment score from baseline to 6 months	6 months

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Terri Swan, BSN, Mount Carmel Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 170214-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share at this time. This intervention is being evaluated for feasibility.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No