Prevention of Postoperative Delirium After Acute Surgery

Study Overview
=================
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.

Official Title
-----------------
Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization

Conditions
-----------------
Postoperative Delirium

Intervention / Treatment
-----------------
* Other: Patient interventions
* Other: Staff education


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multicomponent intervention<br>Pre-, intra- and postoperative interventions applied using the Fast-IM method. | Other: Patient interventions<br>* The multicomponent intervention consists of several elements regarding avoidance of specific pre-medications and optimising the patients condition before surgery (reducing fasting and fluid-fasting time). Per-operative focus on using bispectral index (BIS) guided anaesthesia, Total intravenous anaesthesia (TIVA) as first choice, pain-and PONV (postoperative nausea and vomiting) prophylaxis and treatment. Postoperative focus on: Reducing indwelling catheters, Fluid (p.o. or IV), Nutrition, Mobilisation, Sleep, Non-pharmacological interventions (Shielding, involving of relatives, orientation, optimizing of senses)<br>Other: Staff education<br>* Staff will be educated for at least 1-2 hours. Anaesthesiologist and nurse anaesthetists will receive a brush up on the use of bispectral index (BIS) and the intervention elements that are implemented and monitored. Staff in the PACU, as well as staff in the surgery wards, will be educated in postoperative delirium, learning to identify symptoms of delirium and how to use the screening tool CAM.<br>|
| No Intervention: Standard care<br>Patients are receiving standard care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score. | Patients are screened with the tool Confusion Assessment Method (CAM). A patient will be considered CAM positive, according to the CAM algorithm for diagnosis of delirium that requires the presence of both the first (acute onset and fluctuating course) and the second criteria (inattention) and of either the third (disorganised thinking) or the fourth criterion (altered level of consciousness). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Patients are screened with the tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU). A patient will be considered CAM positive, according to the CAM algorithm for diagnosis of delirium that requires the presence of both the first (acute onset and fluctuating course) and the second criteria (inattention) and of either the third (disorganised thinking) or the fourth criterion (altered level of consciousness). A positive CAM score at any time during the PACU stay is considered as having Inadequate emergence, assessing change from negative to positive score. | Patients are screened at time of arrival and until discharge from PACU | 
| All-cause mortality within 30 days. | All-cause mortality | Day 30 | 
| Length of postoperative stay (LOS). | Length of postoperative stay in hospital | Day 30 | 
| Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery. | Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery after surgery will be assessed. | Day 30 | 
| Number of participants who are readmitted to hospital within 30 days. | Re-admissions are defined as an acute admission which takes place between 4 hours and 30 days after discharge from hospital. The readmission indicator is non-specific, as all readmissions are included, regardless of which hospital the readmission takes place and regardless of the diagnosis at readmission. | Day 30 | 
| Number of participants who are admitted to the intensive care unit after the operation. | Admission to the intensive care unit after the operation. | Day 30 | 
| Number of patients in need of re-operation | Need for re-operation due to complications | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care