Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams (PREPODOT)

Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Aging Disorder
• Intervention / Treatment: Behavioral: Standard non-pharmacological prevention intervention; Behavioral: Occupational therapy intervention

Detailed Description

To determine whether non-pharmacological measures decrease the incidence of POD during the perioperative period in elderly patients undergoing highly complex elective surgeries, it will be performed a randomized clinical trial, where two groups of patients older than 75 years undergoing highly complex elective surgeries will be compared:

1. The first group will receive a protocol of non-pharmacological interventions implemented by occupational therapy teams to prevent delirium plus standard non-pharmacological prevention interventions.
2. The second group will only receive standard non-pharmacological prevention interventions.

This study will be carried out in the surgical units of the Hospital Clinico de la Universidad de Chile (HCUCH) and in the Hospital San Jose (HSJ).

The expected result is to demonstrate that the interventions carried out by occupational therapists decrease the incidence of DPO in a significant way in comparison with standard prevention intervention.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 7690306
      • Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospital admission for highly complex elective surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard non-pharmacological intervention during 5 days after surgery.	Behavioral: Standard non-pharmacological prevention intervention; Prevention of postoperative delirium using standard non-pharmacological prevention measures
Experimental: Treatment; Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery.	Behavioral: Standard non-pharmacological prevention intervention; Prevention of postoperative delirium using standard non-pharmacological prevention measures; Behavioral: Occupational therapy intervention; Prevention of postoperative delirium by occupational therapy intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of hospital stay	Number of days between admission and discharge to the hospital	30 days
Mortality	Percentage of patients who die between the day of surgery and 30 days after surgery	30 days
Severity of delirium	Severity of delirium will be evaluated with questionnaire CAM-S	5 days
Duration of delirium	Number of days in which the patients have delirium	5 days

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica; Hospital de San Jose
• Investigators: Principal Investigator: Antonello Penna, MD/PhD, University of Chile; Principal Investigator: Eduardo Tobar, MD, University of Chile; Principal Investigator: Veronica Rojas, Nurse/MSc, 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: Felipe Salech, MD/PhD, University of Chile; Principal Investigator: Daniela Ponce, Ing, University of Chile; Principal Investigator: Gonzalo Navarrete, MD, University of Chile

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative Delirium; Non-pharmacological; Prevention Measure; Subsyndromal Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: SA17I0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No