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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555996
• Other study ID #: SA10I20015
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: May 19, 2014
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alteration of Cognitive Function
• Delirium
• Incompetence, Functional

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago	RM

Sponsors (3)

Lead Sponsor	Collaborator
University of Chile	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, Fondo Nacional de Investigacion en Salud (FONIS)

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate Delirium duration	Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment	From second until sixth days hospitalization	No
Secondary	Delirium incidence	Proportion of patients in each arm, to developed delirium during daily evaluation	From second until sixth days hospitalization	No
Secondary	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	No
Secondary	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	No
Secondary	Cognitive State	MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge	To seventh day of hospitalization and 72 hours before discharge	No