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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04769518
Registration number
NCT04769518
Ethics application status
Date submitted
16/02/2021
Date registered
24/02/2021
Date last updated
5/04/2022
Titles & IDs
Public title
Advanced Recovery Room Care II - Improved Recovery After Surgery
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Scientific title
Advanced Recovery Room Care - an Iterative Model to Improve Outcomes and Reduce Cost in Perioperative Care
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Secondary ID [1]
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381293
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Universal Trial Number (UTN)
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Trial acronym
ARRCII
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications
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Cost-Benefit Analysis
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Condition category
Condition code
Surgery
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Advanced Recovery Room Care (ARRC)
Active Comparator: Advanced Recovery Room Care (ARRC) - Patients are provided with high acuity care from arrival in Recovery (PACU) until the morning after surgery. This includes higher than normal nursing ratios (1:2), regular frequent rounds by specialist anaesthetic staff, and access to monitoring and medicines (eg vasopressor infusions) not available on normal postoperative surgical wards.
Placebo Comparator: Usual care - Patients are managed in Recovery (PACU), then normal postoperative surgical wards, as per usual care.
Treatment: Surgery: Advanced Recovery Room Care (ARRC)
High acuity care
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Days at Home
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Assessment method [1]
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Number of days out of hospital
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Timepoint [1]
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at 30 after surgery
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Primary outcome [2]
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Days at Home
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Assessment method [2]
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Number of days out of hospital
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Timepoint [2]
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at 90 days after surgery
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Secondary outcome [1]
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Cost-effectiveness
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Assessment method [1]
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Incremental cost effectiveness ratio (ICER): days at home versus hospital costs
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Timepoint [1]
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at 30 days
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Secondary outcome [2]
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Cost-effectiveness
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Assessment method [2]
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Incremental cost effectiveness ratio (ICER): days at home versus hospital costs
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Timepoint [2]
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at 30 days after surgery
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Secondary outcome [3]
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Cost-effectiveness
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Assessment method [3]
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Incremental cost effectiveness ration (ICER): days at home versus hospital costs
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Timepoint [3]
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at 90 days after surgery
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Eligibility
Key inclusion criteria
- Scheduled for elective or emergency surgery
- American College of Surgeons NSQIP-predicted 30-day mortality of 0.7-5%
- Expected inpatient postoperative stay at least 2 nights
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Cardiac and thoracic surgery
- Scheduled for Intensive Care management postoperatively
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/03/2022
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Sample size
Target
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Accrual to date
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Final
857
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Southampton
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Central Adelaide Local Health Network Incorporated
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Moderate-risk surgical patients have a very high incidence of early serious postoperative
complications (approximately 50% at Royal Adelaide Hospital, RAH). This affects patients'
wellbeing and produces a high rate of unplanned postoperative hospital re-admissions. This is
also costly, and patients unnecessarily fill approximately 4000 RAH bed days annually.
A trial of a new model of enhanced care after surgery (Advanced Recovery Room Care, 'ARRC')
demonstrated that complications were quickly identified and expertly addressed. Re-admission
days appeared to decrease by 80%. Business and economic analysis showed (i) patients can
expect 3 extra days at home, (ii) 4000 bed days can be freed annually, and (iii) better care
at lesser cost (technically, ICER = -$600/day at home). Freeing hospital beds, and rapid cost
savings, are critical in this Covid era.
This trial re-introduces ARRC for Orthopaedic, Colorectal, Gynae-Oncology and Neurosurgery,
and other specialties, and formally examines patient outcomes and costs compared to eligible
patient who do not receive ARRC. Data from patient progress and vital signs are to be used to
improve patient risk stratification and triage at defined timepoints before, during, and
after surgery. This may allow better and earlier identification of patients (not) needing
ongoing ARRC, potentially reducing costs of care further without affecting safety. A Markov
cost-effectiveness model provides the platform for cost effectiveness outcomes (Days at Home
V Cost).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04769518
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Guy Ludbrook, MD PhD
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Address
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Central Adelaide Local Health Network
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04769518
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