Clinical trial NCT04857125: Prevention of Postoperative Delirium After Acute Surgery
Official title: Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Delirium
Keywords: Implementation
Prevention
Multicomponent intervention
Anaesthetics, General
Non-cardiac
Acute surgery
Non-pharmacological intervention
Postoperative care
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 476
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The aim of this trial is to evaluate the implementation and effect of an evidence based, multicomponent intervention on postoperative delirium, when fast implemented throughout the patients stay in hospital before, during and after acute surgery in a risk population, the primary outcome being frequency of patients with positive Confusion Assessment Method (CAM) score.

The hypothesis is that the frequency of postoperative delirium will be reduced after implementation of the preventive interventions.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40 or above.
* Patients scheduled for acute abdominal or orthopaedic surgery in general anaesthesia with an expected duration of 30 minutes or more.
* Patients who are scheduled for surgery within 72 hours of hospital admission.
* Patients who are expected to stay in hospital for 24 hours or more.

Exclusion Criteria:

* Patients screened CAM positive before surgery.
* Patients who have already been included in the study
* Patients unable to speak and read Danish.
* Inability to provide consent.

Primary outcomes:
measure: Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.
timeFrame: During the 5 initial postoperative in-hospital days. Patients are screened twice a day; in the morning (7-10 AM) and in the evening (7-11 PM).
Secondary outcomes:
measure: Inadequate emergence identified with the screening tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU), assessing change from negative to positive score.
timeFrame: Patients are screened at time of arrival and until discharge from PACU
measure: All-cause mortality within 30 days.
timeFrame: Day 30
measure: Length of postoperative stay (LOS).
timeFrame: Day 30
measure: Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.
timeFrame: Day 30
measure: Number of participants who are readmitted to hospital within 30 days.
timeFrame: Day 30
measure: Number of participants who are admitted to the intensive care unit after the operation.
timeFrame: Day 30
measure: Number of patients in need of re-operation
timeFrame: Day 30
Other outcomes:
measure: Percentage of staff who have received training
timeFrame: This outcome will be evaluated from when the implementation period starts and until it finishes. The length of this period is 6 months. Staff participation in the training will be registred, and the sessions repeated during the 6 months.
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
Study officials:
affiliation: University of Copenhagen
name: Christian Meyhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: