Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

NCT03704090 | Completed DMC

• 1 other identifier: SA17I0030
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs. Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD. The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries. The hypothesis is that the application of these measures decreases the incidence of delirium in this population.

Conditions

Postoperative Delirium; Aging Disorder

Keywords

Postoperative Delirium; Prevention Measure; Non-pharmacological; Subsyndromal Delirium

Outcome Measures

Primary Outcomes (2)

• Delirium

  Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)

  5 days

• Subsyndromal delirium

  Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)

  5 days

Secondary Outcomes (4)

• Lenght of hospital stay

  30 days

• Mortality

  30 days

• Severity of delirium

  5 days

• Duration of delirium

  5 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard non-pharmacological intervention during 5 days after surgery.

Behavioral: Standard non-pharmacological prevention intervention

Treatment

EXPERIMENTAL

Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery.

Behavioral: Occupational therapy intervention; Behavioral: Standard non-pharmacological prevention intervention

Interventions

Occupational therapy intervention BEHAVIORAL

Prevention of postoperative delirium by occupational therapy intervention

Treatment

Standard non-pharmacological prevention intervention BEHAVIORAL

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Control; Treatment

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hospital admission for highly complex elective surgery

You may not qualify if:

• History of cognitive impairment.
• A low score in Mini-Mental State Examination (MMSE): \<23 points if the patient has 6 or more years of schooling, and \<18 points if the patient has \<6 years of schooling.
• Severe communication disorder and cultural language limitation (language other than Spanish).
• Delirium on admission or prior to the start of the intervention (measured with CAM).
• Patient enrolled in another study

Sponsors & Collaborators

• University of Chile: lead
• Hospital de San Jose: collaborator
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Related Publications (2)

• Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.

  PMID: 27660922 RESULT

• Alvarez EA, Rojas VA, Caipo LI, Galaz MM, Ponce DP, Gutierrez RG, Salech F, Tobar E, Reyes FI, Vergara RC, Egana JI, Briceno CA, Penna A. Non-pharmacological prevention of postoperative delirium by occupational therapy teams: A randomized clinical trial. Front Med (Lausanne). 2023 Feb 2;10:1099594. doi: 10.3389/fmed.2023.1099594. eCollection 2023.

  PMID: 36817762 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Antonello Penna, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Evelyn Alvarez, TO/MSc

  Universidad Central/Universidad de Chile

  PRINCIPAL INVESTIGATOR

• Constanza Briceño, TO/MSc

  University of Chile

  PRINCIPAL INVESTIGATOR

• Eduardo Tobar, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Felipe Salech, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Daniela Ponce, Ing

  University of Chile

  PRINCIPAL INVESTIGATOR

• Veronica Rojas, Nurse/MSc

  University of Chile

  PRINCIPAL INVESTIGATOR

• Gonzalo Navarrete, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients were randomized in 16 blocks of 10 patients and only one investigator has the randomized information. This researcher will not have any role in the recruitment, intervention, and diagnosis of postoperative delirium. Also, the analysis of data will be performed by researchers who will be masked to the randomization information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistent Professor

Model Details: Elderly patients who will undergo major surgery will be randomized to 2 prevention groups of postoperative delirium: 1. Control: standard non-pharmacological prevention measures for 5 days after surgery. 2. Intervention: occupational therapist plus standard non-pharmacological prevention measures for 5 days after surgery.

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 12, 2018
• Study Start: October 1, 2018
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)