Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000296134
Ethics application status
Approved
Date submitted
18/02/2019
Date registered
26/02/2019
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
26/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing the risk of post-operative delirium in elderly hip fracture surgical patients by implementing a multidisciplinary approach to analgesia, education, and medications
Scientific title
Delirium reduction after hip fracture surgery through a multidisciplinary care bundle
Secondary ID [1] 297434 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delirium 311609 0
hip fracture 311610 0
Condition category
Condition code
Neurological 310235 310235 0 0
Other neurological disorders
Surgery 310236 310236 0 0
Other surgery
Injuries and Accidents 310326 310326 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multidisciplinary care bundle including:
1. Ward and staff education on causes and risks of delirium. Education on national guidelines for clinical management of post-operative delirium
Particulars include:
- oral powerpoint presentations at fortnightly department training sessions over study period (prospective recruitment of 150 patients managed under care bundle), designed specific for this study
- hardcopy handouts of national guidelines during sessions
- laminated cognitive aids describing protocol placed on noticeboards, designed specific for this study
- all delivered by researchers

2. Initial fascia iliaca block for analgesia when presented to the emergency department
set protocol of 30ml of 0.2% plain ropivacaine, single dose, via ultrasound-guidance, prior to discharge to ward

3. Second fascia iliaca block to continue analgesia when presenting for hip fracture surgery
set protocol of 30ml of 0.2% plain ropivacaine, single dose, via ultrasound-guidance, prior to surgical incision

4. Rationalisation of medications to reduce polypharmacy and known drug triggers for post-operative delirium by emergency physicians, anaesthestists, orthogeriatricians, and ward medical staff

5. compliance to above audited weekly by researchers. Compliance rates published fortnightly as educational newsletters sent electonically to all clinical staff, and as hardcopy on department notice boards.
Compliance data compiled by manual search through hardcopy medical record of each patient, as well as electronic clinical notes, and of medication charts
Intervention code [1] 313686 0
Behaviour
Intervention code [2] 313688 0
Treatment: Drugs
Comparator / control treatment
150 hip fracture patients admitted to Liverpool Hospital prior to start of intervention, who received standard care, in 2017
Control group
Historical

Outcomes
Primary outcome [1] 319132 0
new onset post-operative delirium, using the Confusion Assessment Method. Researchers will directly screen all patients on the ward
Timepoint [1] 319132 0
Day 3 post-operative
Secondary outcome [1] 367065 0
mortality, as checked by researchers using medical records, and phone call to general practitioner or next of kin
Timepoint [1] 367065 0
Day 30 post-operative
Secondary outcome [2] 367066 0
composite secondary outcome of major morbidity, cardiac ischaemia, congestive cardiac failure, cardiac arrest, stroke, pulmonary embolus, acute kidney injury. Researchers will perform manual screen of medical records, biochemistry results, pathology and radiology results, and a phone call to the patient's general practitioner or next of kin
Timepoint [2] 367066 0
Day 30 post-operative
Secondary outcome [3] 367067 0
residential status, through manual phone call to patient's general practitioner or next of kin
Timepoint [3] 367067 0
Day 30 post-operative
Secondary outcome [4] 367068 0
walking ability assessed through phone call to general practitioner, or next of kin
Timepoint [4] 367068 0
Day 30 post-operative

Eligibility
Key inclusion criteria
emergency surgery
isolated single hip fracture, defined as between femoral head and 5cm below the lesser trochanter
age greater than 50 years old
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
elective admission
multiple fractures
age less than 50 years old

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
before-and-after trial design
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
primary outcome is categorical, chi-square test to be used
secondary outcomes are categorical, chi-square test to be used

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
1/11/2018
Date of last data collection
Anticipated
Actual
7/12/2018
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13179 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 25734 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 302003 0
Hospital
Name [1] 302003 0
Department of Anaesthesia, Liverpool Hospital
Country [1] 302003 0
Australia
Primary sponsor type
Individual
Name
A/Prof Alwin Chuan
Address
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 301787 0
None
Name [1] 301787 0
Address [1] 301787 0
Country [1] 301787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302679 0
South western Sydney LHD HREC
Ethics committee address [1] 302679 0
Locked Bag 7103
LIVERPOOL BC,
NSW, 1871
Ethics committee country [1] 302679 0
Australia
Date submitted for ethics approval [1] 302679 0
01/03/2017
Approval date [1] 302679 0
28/05/2017
Ethics approval number [1] 302679 0
HREC/17/LPOOL/19

Summary
Brief summary
Delirium is a common complication of patients admitted for hip fracture surgery, and is associated with increased risk of mortality, morbidity, and loss of functional independence, as well as high social, nursing and health care costs. National guidelines describe care plans and delirium reduction strategies, but inadequate education and lack of coordinated clinical management results in large variations in quality of care in Australian and New Zealand hospitals.
This study will investigate if a multidisciplinary care bundle, which includes evidence based clinical interventions and regular educational initiatives reduces the risk of delirium in hip fracture patients classified as intermediate or high risk by 40%.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91038 0
A/Prof Alwin Chuan
Address 91038 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 91038 0
Australia
Phone 91038 0
+61 2 8738 3173
Fax 91038 0
Email 91038 0
[email protected]
Contact person for public queries
Name 91039 0
A/Prof Alwin Chuan
Address 91039 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 91039 0
Australia
Phone 91039 0
+61 2 8738 3173
Fax 91039 0
Email 91039 0
[email protected]
Contact person for scientific queries
Name 91040 0
A/Prof Alwin Chuan
Address 91040 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 91040 0
Australia
Phone 91040 0
+61 2 8738 3173
Fax 91040 0
Email 91040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No approval from ethics committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.