Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

Postoperative Delirium Clinical Trial

— PREPODOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704090
• Other study ID #: SA17I0030
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 9, 2021

Study information

• Verified date: April 2021
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging Disorder
• Delirium
• Postoperative Delirium

Intervention

Behavioral:
• Occupational therapy intervention
Prevention of postoperative delirium by occupational therapy intervention
• Standard non-pharmacological prevention intervention
Prevention of postoperative delirium using standard non-pharmacological prevention measures

Locations

Country	Name	City	State
Chile	Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (3)

Lead Sponsor	Collaborator
University of Chile	Comisión Nacional de Investigación Científica y Tecnológica, Hospital de San Jose

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Álvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceño CD, González 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)	5 days
Primary	Subsyndromal delirium	Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)	5 days
Secondary	Lenght of hospital stay	Number of days between admission and discharge to the hospital	30 days
Secondary	Mortality	Percentage of patients who die between the day of surgery and 30 days after surgery	30 days
Secondary	Severity of delirium	Severity of delirium will be evaluated with questionnaire CAM-S	5 days
Secondary	Duration of delirium	Number of days in which the patients have delirium	5 days