Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-03-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Delirium Aging Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

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.

Study Groups

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Control

Standard non-pharmacological intervention during 5 days after surgery.

Group Type ACTIVE_COMPARATOR

Standard non-pharmacological prevention intervention

Intervention Type BEHAVIORAL

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Treatment

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

Group Type EXPERIMENTAL

Occupational therapy intervention

Intervention Type BEHAVIORAL

Prevention of postoperative delirium by occupational therapy intervention

Standard non-pharmacological prevention intervention

Intervention Type BEHAVIORAL

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Interventions

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Occupational therapy intervention

Prevention of postoperative delirium by occupational therapy intervention

Intervention Type BEHAVIORAL

Standard non-pharmacological prevention intervention

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No