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

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

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).

Study Overview

• Status: Completed
• Conditions: Delirium; Alteration of Cognitive Function; Incompetence, Functional
• Intervention / Treatment: Behavioral: Early and Intensive Occupational Therapy; Behavioral: Standard non-pharmacological delirium prevention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile
      • Hospital Clínico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early and intensive OT	Behavioral: Early and Intensive Occupational Therapy; 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.; Other Names: Active hospital routine
ACTIVE_COMPARATOR: Standard non-pharmacological prevention	Behavioral: Standard non-pharmacological delirium prevention; 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.; Other Names: Recommended non-pharmacological treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: National Fund for Research and Development in Health, Chile; Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Investigators: Principal Investigator: Evelyn Alvarez, University of Chile; Study Chair: Maricel Garrido, University of Chile; Study Chair: Eduardo Tobar, University of Chile; Study Chair: Rolando Aranda, University of Chile

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (ESTIMATE): March 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: delirium; occupational therapy; critically ill patients; older; cognitive status
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: SA10I20015