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

NCT ID: NCT01555996

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-12-31

Brief Summary

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

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.

Conditions

Delirium; Alteration of Cognitive Function; Incompetence, Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early and intensive OT

Group Type: EXPERIMENTAL

Early and Intensive Occupational Therapy

Intervention Type: BEHAVIORAL

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.

Standard non-pharmacological prevention

Group Type: ACTIVE_COMPARATOR

Standard non-pharmacological delirium prevention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Active hospital routine; Recommended non-pharmacological treatment

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

National Fund for Research and Development in Health, Chile

OTHER

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Evelyn Alvarez Espinoza, OT, Principal Investigator

E Alvarez

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evelyn Alvarez

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Maricel Garrido

Role: STUDY_CHAIR

University of Chile

Eduardo Tobar

Role: STUDY_CHAIR

University of Chile

Rolando Aranda

Role: STUDY_CHAIR

University of Chile

Locations

Hospital Clinico Universidad de Chile

Santiago, RM, Chile

Countries

Chile

Other Identifiers

SA10I20015

Identifier Type: -

Identifier Source: org_study_id