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

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ClinicalTrials.gov Identifier: NCT03704090
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Hospital de San Jose
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Antonello Penna, University of Chile

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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:

  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.
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 : October 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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




Primary Outcome Measures :
  1. Delirium [ Time Frame: 5 days ]
    Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)

  2. Subsyndromal delirium [ Time Frame: 5 days ]
    Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)


Secondary Outcome Measures :
  1. Lenght of hospital stay [ Time Frame: 30 days ]
    Number of days between admission and discharge to the hospital

  2. Mortality [ Time Frame: 30 days ]
    Percentage of patients who die between the day of surgery and 30 days after surgery

  3. Severity of delirium [ Time Frame: 5 days ]
    Severity of delirium will be evaluated with questionnaire CAM-S

  4. Duration of delirium [ Time Frame: 5 days ]
    Number of days in which the patients have delirium



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704090


Contacts
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Contact: Antonello Penna, MD/PhD 56229789405 apenna@uchile.cl
Contact: Veronica Rojas, Nurse/MSc 56229789405 veritorojas@gmail.com

Locations
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Chile
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile Recruiting
Santiago, RM, Chile, 7690306
Contact: Daniela Ponce, Ing    56229789405    dponcedelavega@gmail.com   
Contact: Veronica Rojas, Nurse/MSc    56229789405    Veritorojas@gmail.com   
Sponsors and Collaborators
University of Chile
Hospital de San Jose
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
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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
Publications of Results:
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Responsible Party: Antonello Penna, Anesthesiologist, Assistent Professor, University of Chile
ClinicalTrials.gov Identifier: NCT03704090    
Other Study ID Numbers: SA17I0030
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonello Penna, University of Chile:
Postoperative Delirium
Prevention Measure
Non-pharmacological
Subsyndromal Delirium
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders