Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000472875
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
21/04/2021
Date last updated
30/03/2022
Date data sharing statement initially provided
21/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advanced Recovery Room Care - a trial of enhanced care after surgery for patients at medium risk of complications after surgery
Scientific title
Advanced Recovery Room Care – a trial investigating the impact of enhanced care after surgery on recovery outcomes, cost, and cost-effectiveness, for patients at medium risk of complications after surgery
Secondary ID [1] 303264 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record



Health condition
Health condition(s) or problem(s) studied:
Postoperative complications 320450 0
Condition category
Condition code
Anaesthesiology 318341 318341 0 0
Other anaesthesiology
Surgery 318342 318342 0 0
Other surgery
Public Health 319357 319357 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Moderate risk patients (0.7-5% 30-day mortality predicted by NSQIP risk scoring) will be allocated to Advanced Recovery Room Care (ARRC).
This is a unit which provides extended recovery room-level care from anaesthetists and nurses, supported by surgeons and other specialties, as needed, until the morning after surgery, for a maximum of 24 hours.
Allocation to ARRC is based on formal screening tools (NSQIP), and care is largely checklist- and protocol-driven. Specific measurement of compliance with enrolment and care is conducted.
Intervention code [1] 319564 0
Treatment: Other
Comparator / control treatment
Comparator group is those receiving standard Recovery Room then surgical ward care after surgery.
Recovery Room care is according to standard practices (clinical judgement-based). Discharge to the surgical ward is based on a Royal Adelaide Hospital clinical guideline.
Ward care is as per usual postoperative care decided by the surgical unit and its clinicians, with discharge home decided along similar lines.
Such usual care does not have struct guidelines or protocols and, as such, will not undergo audit.
Control group
Active

Outcomes
Primary outcome [1] 326311 0
Days at home at 30 days after surgery - measured from medical records and phone follow up
Timepoint [1] 326311 0
30 days after surgery - measured from medical records and phone follow up
Primary outcome [2] 327224 0
Days at home at 90 days after surgery - measured from medical records and phone follow up
Timepoint [2] 327224 0
90 days after surgery - measured from medical records and phone follow up
Secondary outcome [1] 391007 0
Cost-effectiveness: ICER of days at home and hospital costs.
Determined using a Markov model of postoperative care, with data from hospital finance records and patient details by phone call on out of hospital locations .
Timepoint [1] 391007 0
30 and 90 days after surgery - measured from medical records and phone follow up

Eligibility
Key inclusion criteria
Patients are moderate-risk patients (NSQIP-predicted 30-day mortality of 0.7-5%) undergoing elective or emergency surgery and scheduled for postoperative ward care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Scheduled for Intensive Care management after surgery.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear regression to find the mean difference in days-at-home (DAH) at 30/90 days between the case and control groups. Incremental cost effectiveness ratio between the cases and control groups using transition state Markov modelling

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Stopped early after interim analysis
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
1/06/2022
Actual
23/11/2021
Date of last data collection
Anticipated
1/09/2022
Actual
24/03/2022
Sample size
Target
1130
Accrual to date
Final
857
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18505 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 32824 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 307673 0
Charities/Societies/Foundations
Name [1] 307673 0
Health Services Charitable Gifts Board
Country [1] 307673 0
Australia
Primary sponsor type
Hospital
Name
The Royal Adelaide Hospital
Address
1 Port Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308371 0
None
Name [1] 308371 0
Address [1] 308371 0
Country [1] 308371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307711 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307711 0
Ethics committee country [1] 307711 0
Australia
Date submitted for ethics approval [1] 307711 0
01/12/2020
Approval date [1] 307711 0
13/01/2021
Ethics approval number [1] 307711 0
14076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108230 0
Prof Guy Ludbrook
Address 108230 0
Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000
Country 108230 0
Australia
Phone 108230 0
+61 413817901
Fax 108230 0
+61 870746146
Email 108230 0
[email protected]
Contact person for public queries
Name 108231 0
Guy Ludbrook
Address 108231 0
Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000
Country 108231 0
Australia
Phone 108231 0
+61 413817901
Fax 108231 0
+61 870746146
Email 108231 0
[email protected]
Contact person for scientific queries
Name 108232 0
Guy Ludbrook
Address 108232 0
Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000
Country 108232 0
Australia
Phone 108232 0
+61 413817901
Fax 108232 0
+61 870746146
Email 108232 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


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.