Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

Study Overview
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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.

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: 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.

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

Conditions
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Postoperative Delirium, Aging Disorder

Intervention / Treatment
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* Behavioral: Occupational therapy intervention
* Behavioral: Standard non-pharmacological prevention intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium