Postoperative DeliriumPREPODOTNCT03704090
Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams
A study testing Occupational therapy intervention and Standard non-pharmacological prevention intervention in people with Postoperative Delirium and Aging Disorder, run by University of Chile at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Postoperative Delirium, Aging Disorder
- What is being tested?
- Occupational therapy intervention and Standard non-pharmacological prevention intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2018to 9 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospital admission for highly complex elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
About this study
Official title: Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Postoperative Delirium, Aging Disorder
- Being tested
- Occupational therapy intervention, Standard non-pharmacological prevention intervention
- Keywords
- Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapy interventionBehavioural
Prevention of postoperative delirium by occupational therapy intervention
Standard non-pharmacological prevention interventionBehavioural
Prevention of postoperative delirium using standard non-pharmacological prevention measures
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard non-pharmacological intervention during 5 days after surgery. Receives: Behavioral: Standard non-pharmacological prevention intervention |
| Treatment | Experimental | Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery. Receives: Behavioral: Occupational therapy intervention; Behavioral: Standard non-pharmacological prevention intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Measured: 5 days
Subsyndromal delirium
Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)
Measured: 5 days
Secondary outcomes (4)
Lenght of hospital stay
Number of days between admission and discharge to the hospital
Measured: 30 days
Mortality
Percentage of patients who die between the day of surgery and 30 days after surgery
Measured: 30 days
Severity of delirium
Severity of delirium will be evaluated with questionnaire CAM-S
Measured: 5 days
Duration of delirium
Number of days in which the patients have delirium
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Oct 2018
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de San Jose, Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Antonello Penna, University of Chile
- Investigators
- Antonello Penna, MD/PhD, Principal investigator, University of ChileEvelyn Alvarez, TO/MSc, Principal investigator, Universidad Central/Universidad de ChileConstanza Briceño, TO/MSc, Principal investigator, University of ChileEduardo Tobar, MD, Principal investigator, University of ChileFelipe Salech, MD/PhD, Principal investigator, University of ChileDaniela Ponce, Ing, Principal investigator, University of ChileVeronica Rojas, Nurse/MSc, Principal investigator, University of ChileGonzalo Navarrete, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704090
- Sponsor's protocol ID
- SA17I0030
- Acronym
- PREPODOT
- Status last verified
- Apr 2021
- First submitted
- 7 Oct 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27660922Alvarez EA, Rojas VA, Caipo LI, Galaz MM, Ponce DP, Gutierrez RG, Salech F, Tobar E, Reyes FI, Vergara RC, Egana JI, Briceno CA, Penna A. Non-pharmacological prevention of postoperative delirium by occupational therapy teams: A randomized clinical trial. Front Med (Lausanne). 2023 Feb 2;10:1099594. doi: 10.3389/fmed.2023.1099594. eCollection 2023.
PubMed 36817762
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
- ClinicalTrials.gov ID
- NCT03704090
- Acronym / sponsor ID
- PREPODOT / SA17I0030
- Conditions
- Postoperative Delirium, Aging Disorder
- Keywords
- Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital de San Jose, Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard non-pharmacological prevention interventionStandard non-pharmacological intervention during 5 days after surgery. |
| Treatment | Experimental | Behavioral: Occupational therapy intervention, Behavioral: Standard non-pharmacological prevention interventionOccupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Hospital admission for highly complex elective surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational therapy interventionPrevention of postoperative delirium by occupational therapy intervention | Behavioural | Treatment |
| Standard non-pharmacological prevention interventionPrevention of postoperative delirium using standard non-pharmacological prevention measures | Behavioural | Control, Treatment |
Primary outcome
Delirium
Time frame: 5 days
Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Subsyndromal delirium
Time frame: 5 days
Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)
4 secondary outcomes
Lenght of hospital stay
Time frame: 30 days
Mortality
Time frame: 30 days
Severity of delirium
Time frame: 5 days
Duration of delirium
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Results publication: PubMed 27660922Alvarez 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.
- Derived from this study: PubMed 36817762Alvarez EA, Rojas VA, Caipo LI, Galaz MM, Ponce DP, Gutierrez RG, Salech F, Tobar E, Reyes FI, Vergara RC, Egana JI, Briceno CA, Penna A. Non-pharmacological prevention of postoperative delirium by occupational therapy teams: A randomized clinical trial. Front Med (Lausanne). 2023 Feb 2;10:1099594. doi: 10.3389/fmed.2023.1099594. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonello Penna, MD/PhD principal investigator
University of Chile
Evelyn Alvarez, TO/MSc principal investigator
Universidad Central/Universidad de Chile
Constanza Briceño, TO/MSc principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy intervention and Standard non-pharmacological prevention intervention in people with Postoperative Delirium and Aging Disorder, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704090, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.