Clinical trial NCT03704090: Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams
Official title: Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Aging Disorder
Keywords: Postoperative Delirium
Prevention Measure
Non-pharmacological
Subsyndromal Delirium
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Hospital de San Jose
name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2018-10-12
Enrollment: 160
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delirium
timeFrame: 5 days
measure: Subsyndromal delirium
timeFrame: 5 days
Secondary outcomes:
measure: Lenght of hospital stay
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Severity of delirium
timeFrame: 5 days
measure: Duration of delirium
timeFrame: 5 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
state: RM
Study officials:
affiliation: University of Chile
name: Antonello Penna, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Central/Universidad de Chile
name: Evelyn Alvarez, TO/MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Constanza Briceño, TO/MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Eduardo Tobar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Felipe Salech, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Daniela Ponce, Ing
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Veronica Rojas, Nurse/MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Gonzalo Navarrete, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.