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

This study has been completed.
Sponsor:
Collaborators:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Fondo Nacional de Investigacion en Salud (FONIS)
Information provided by (Responsible Party):
Evelyn Alvarez Espinoza, OT, Principal Investigator, University of Chile
ClinicalTrials.gov Identifier:
NCT01555996
First received: January 10, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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).

Condition Intervention
Delirium
Alteration of Cognitive Function
Incompetence, Functional
Behavioral: Early and Intensive Occupational Therapy
Behavioral: Standard non-pharmacological delirium prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • To evaluate Delirium duration [ Time Frame: From second until sixth days hospitalization ] [ Designated as safety issue: No ]
    Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment


Secondary Outcome Measures:
  • Delirium incidence [ Time Frame: From second until sixth days hospitalization ] [ Designated as safety issue: No ]
    Proportion of patients in each arm, to developed delirium during daily evaluation

  • Functional independence [ Time Frame: To seventh day of hospitalization and 72 hours before discharge ] [ Designated as safety issue: No ]
    Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument

  • Strenght of Grip evaluation [ Time Frame: To seventh day of hospitalization and 72 hours before discharge ] [ Designated as safety issue: No ]
    Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge

  • Cognitive State [ Time Frame: To seventh day of hospitalization and 72 hours before discharge ] [ Designated as safety issue: No ]
    MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge


Enrollment: 126
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Recommended non-pharmacological treatment

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.

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555996

Locations
Chile
Hospital Clinico Universidad de Chile
Santiago, RM, Chile
Sponsors and Collaborators
University of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Fondo Nacional de Investigacion en Salud (FONIS)
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
  More Information

No publications provided

Responsible Party: Evelyn Alvarez Espinoza, OT, Principal Investigator, E Alvarez, University of Chile
ClinicalTrials.gov Identifier: NCT01555996     History of Changes
Other Study ID Numbers: SA10I20015
Study First Received: January 10, 2012
Last Updated: May 19, 2014
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
older
delirium
cognitive status
occupational therapy
critically ill patients

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014