Prevention of Postoperative Delirium After Acute Surgery (POD-CARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: Patient interventions; Other: Staff education

• Study Type: Interventional
• Enrollment (Anticipated): 476
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sine Eriksen, Cand. Cur.; Phone Number: + 45 51920075; Email: sine.alette.nogel.eriksen.01@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Bispebjerg and Frederiksberg Hospital
    • Contact: Email: sine.alette.nogel.eriksen.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multicomponent intervention; Pre-, intra- and postoperative interventions applied using the Fast-IM method.	Other: Patient interventions; 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); Other: Staff education; 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.
No Intervention: Standard care; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of staff who have received training	It will be registered how many of the staff have received the training, the target being 80%. Staff participation in the training will be registred, and the sessions repeated during the 6 months, until 80% of the staff, or more, have recieved the training.	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.

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Christian Meyhoff, MD, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Implementation; Postoperative care; Prevention; Multicomponent intervention; Non-pharmacological intervention; Non-cardiac; Acute surgery; Anaesthetics, General
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: H-20067775

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No