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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Advanced Recovery Room Care - an Iterative Model to Improve Outcomes and Reduce Cost in Perioperative Care
Secondary ID [1] 0 0
381293
Universal Trial Number (UTN)
Trial acronym
ARRCII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications 0 0
Cost-Benefit Analysis 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days at Home
Timepoint [1] 0 0
at 30 after surgery
Primary outcome [2] 0 0
Days at Home
Timepoint [2] 0 0
at 90 days after surgery
Secondary outcome [1] 0 0
Cost-effectiveness
Timepoint [1] 0 0
at 30 days
Secondary outcome [2] 0 0
Cost-effectiveness
Timepoint [2] 0 0
at 30 days after surgery
Secondary outcome [3] 0 0
Cost-effectiveness
Timepoint [3] 0 0
at 90 days after surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cardiac and thoracic surgery
* Scheduled for Intensive Care management postoperatively

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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2022
Sample size
Target
Accrual to date
Final
857
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Southampton
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Central Adelaide Local Health Network Incorporated
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT04769518
Trial related presentations / publications
Ludbrook G, Lloyd C, Story D, Maddern G, Riedel B, Richardson I, Scott D, Louise J, Edwards S. The effect of advanced recovery room care on postoperative outcomes in moderate-risk surgical patients: a multicentre feasibility study. Anaesthesia. 2021 Apr;76(4):480-488. doi: 10.1111/anae.15260. Epub 2020 Oct 7.
Lloyd C, Proctor L, Au M, Story D, Edwards S, Ludbrook G. Incidence of early major adverse events after surgery in moderate-risk patients: early postoperative adverse events. Br J Anaesth. 2020 Jan;124(1):e9-e10. doi: 10.1016/j.bja.2019.10.002. Epub 2019 Nov 6. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook, MD PhD
Address 0 0
Central Adelaide Local Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04769518