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

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT03704090

Collaborator

Hospital de San Jose (Other), Comisión Nacional de Investigación Científica y Tecnológica (Other)

160

Enrollment

Location

Arms

29.2

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium Aging Disorder	Behavioral: Occupational therapy intervention Behavioral: Standard non-pharmacological prevention intervention	N/A

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:

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.
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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 9, 2021

Actual Study Completion Date :

Mar 9, 2021

Arms and Interventions

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

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: Occupational therapy intervention

Prevention of postoperative delirium by occupational therapy intervention

Behavioral: Standard non-pharmacological prevention intervention

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Outcome Measures

Primary Outcome Measures

Delirium [5 days]
Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Subsyndromal delirium [5 days]
Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile	Santiago	RM	Chile	7690306

Sponsors and Collaborators

University of Chile
Hospital de San Jose
Comisión Nacional de Investigación Científica y Tecnológica

Investigators

Principal Investigator: 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