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Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704090
Acronym
PREPODOT
Enrollment
160
Registered
2018-10-12
Start date
2018-10-01
Completion date
2021-03-09
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Disorder, Postoperative Delirium

Keywords

Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium

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.

Interventions

Prevention of postoperative delirium by occupational therapy intervention

BEHAVIORALStandard non-pharmacological prevention intervention

Prevention of postoperative delirium using standard non-pharmacological prevention measures

Sponsors

Hospital de San Jose
CollaboratorOTHER
Comisión Nacional de Investigación Científica y Tecnológica
CollaboratorOTHER_GOV
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, 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.

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.

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Delirium5 daysDeveloping postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Subsyndromal delirium5 daysDeveloping postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)

Secondary

MeasureTime frameDescription
Lenght of hospital stay30 daysNumber of days between admission and discharge to the hospital
Mortality30 daysPercentage of patients who die between the day of surgery and 30 days after surgery
Severity of delirium5 daysSeverity of delirium will be evaluated with questionnaire CAM-S
Duration of delirium5 daysNumber of days in which the patients have delirium

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026