Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit

Study Overview
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Brief Summary
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This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients: standard non-pharmacological prevention intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).

Detailed Description
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Delirium is a complication in older, with incidences 70-87% in CCU. This increases mortality, hospital stay, hospital cost, and cognitive impairment. Occupational Therapy (OT) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. This study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted CCU.

Official Title
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Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)

Conditions
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Delirium, Alteration of Cognitive Function, Incompetence, Functional

Intervention / Treatment
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* Behavioral: Early and Intensive Occupational Therapy
* Behavioral: Standard non-pharmacological delirium prevention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 60 years. Admission to CCU for monitoring by acute or chronic illness, expected more than 24 hours Informed consent of patient or family related. Exclusion Criteria: Cognitive impairment before to admission (measured by Test Reporter-TIN). Severe disorder of communication and cultural constraint of language (inhability of properly communicating in Spanish) Delirium at CCU admission or at the beginning of the intervention Need for mechanical ventilation Early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early and intensive OT<br> | Behavioral: Early and Intensive Occupational Therapy<br>* Intervention group:Standard non-pharmacological prevention plus early and intensive OT. Begin in the first 24 hours in CCU admission. OT areas:1)Multi-sensory stimulation:Intense external stimulation, increase alertness,2)Positioning: Fixtures like dorxi-flexion splints, devices for preventing edema,etc,3)Cognitive Stimulation: Awareness, orientation, attention, memory, calculation, praxis and language,4)Training Activities of Daily Living (ADL): Keep a daily routine and independence in hygiene, grooming and feeding,5)Upper Limb Motor Stimulation (ULMS): Activate functional movement and strength ,6)Family involvement. General Guidelines for intervention: Visit of an OT twice a day, 40 minutes each time, for 5 days; meeting of family training for promote strategies during the daily visit.<br>* Other names: Active hospital routine;|
| Active Comparator: Standard non-pharmacological prevention<br> | Behavioral: Standard non-pharmacological delirium prevention<br>* Non-pharmacological strategies are the first line of approach in the prevention of delirium. It is recommended to implement some of these strategies, which are: Reorientation protocol, including information 4 times a day about time, date, place and reason for hospitalization; early mobilization by physical therapist 3 times a day, corrected sensory impairment (use such as eyeglasses, hearing aids); environment management, use clock and calendar in the patient´s room, promote supervision of a professional or family to avoid physical restraints; sleep protocol, like lower light, noise and nighttime drug administration and finally, reduction of any anticholinergic drugs and minimize the use of benzodiazepines.<br>* Other names: Recommended non-pharmacological treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate Delirium duration | Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment | From second until sixth days hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence | Proportion of patients in each arm, to developed delirium during daily evaluation | From second until sixth days hospitalization | 
| Functional independence | Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument | To seventh day of hospitalization and 72 hours before discharge | 
| Strenght of Grip evaluation | Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge | To seventh day of hospitalization and 72 hours before discharge | 
| Cognitive State | MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge | To seventh day of hospitalization and 72 hours before discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older, delirium, cognitive status, occupational therapy, critically ill patients