Back to resultsPrevention of Postoperative Delirium After Acute Surgery (POD-CARE)
Primary Purpose
Postoperative Delirium
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Patient interventions
Staff education
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Delirium focused on measuring Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care
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.
Sites / Locations
- Bispebjerg and Frederiksberg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Multicomponent intervention
Standard care
Arm Description
Pre-, intra- and postoperative interventions applied using the Fast-IM method.
Patients are receiving standard care.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
All-cause mortality within 30 days.
All-cause mortality
Length of postoperative stay (LOS).
Length of postoperative stay in hospital
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.
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.
Number of participants who are admitted to the intensive care unit after the operation.
Admission to the intensive care unit after the operation.
Number of patients in need of re-operation
Need for re-operation due to complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04857125
Brief Title
Prevention of Postoperative Delirium After Acute Surgery
Acronym
POD-CARE
Official Title
Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
The statistician will be blinded from the groups, when assessing the primary outcome.
Allocation
Non-Randomized
Enrollment
476 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multicomponent intervention
Arm Type
Active Comparator
Arm Description
Pre-, intra- and postoperative interventions applied using the Fast-IM method.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients are receiving standard care.
Intervention Type
Other
Intervention Name(s)
Patient interventions
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Staff education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.
Description
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).
Time Frame
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 Measure Information:
Title
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.
Description
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.
Time Frame
Patients are screened at time of arrival and until discharge from PACU
Title
All-cause mortality within 30 days.
Description
All-cause mortality
Time Frame
Day 30
Title
Length of postoperative stay (LOS).
Description
Length of postoperative stay in hospital
Time Frame
Day 30
Title
Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.
Description
Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery after surgery will be assessed.
Time Frame
Day 30
Title
Number of participants who are readmitted to hospital within 30 days.
Description
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.
Time Frame
Day 30
Title
Number of participants who are admitted to the intensive care unit after the operation.
Description
Admission to the intensive care unit after the operation.
Time Frame
Day 30
Title
Number of patients in need of re-operation
Description
Need for re-operation due to complications
Time Frame
Day 30
Other Pre-specified Outcome Measures:
Title
Percentage of staff who have received training
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sine Eriksen, Cand. Cur.
Phone
+ 45 51920075
Email
sine.alette.nogel.eriksen.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Meyhoff, MD, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Email
sine.alette.nogel.eriksen.01@regionh.dk
12. IPD Sharing Statement
Learn more about this trial
Prevention of Postoperative Delirium After Acute Surgery
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