ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postoperative complications

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Surgery

Other surgery

Public Health

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]

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]

Days at home at 30 days after surgery - measured from medical records and phone follow up

Timepoint [1]

30 days after surgery - measured from medical records and phone follow up

Primary outcome [2]

Days at home at 90 days after surgery - measured from medical records and phone follow up

Timepoint [2]

90 days after surgery - measured from medical records and phone follow up

Secondary outcome [1]

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]

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?

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Health Services Charitable Gifts Board

Address [1]

PO Box 10559
Adelaide BC SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Royal Adelaide Hospital

Address

1 Port Road, Adelaide, SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

1 Port Road Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2020

Approval date [1]

13/01/2021

Ethics approval number [1]

14076

Summary

Brief summary

Moderate-risk surgical patients appear to have a high incidence of early, often undetected, serious postoperative complications. This affects patients’ wellbeing and produces a high rate of unplanned postoperative hospital re-admissions. This is also costly, and patients unnecessarily fill inpatient beds. 
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 be decreased by 80%. Business and economic analysis showed (i) patients could expect 3 extra days at home, (ii) 4000 bed days could be freed annually, and (iii) better care at lesser cost (technically, ICER of -$600/day at home). Freeing hospital beds, and rapid cost savings, are especially important with current economic challenges with Covid.
This trial re-introduces ARRC for Orthopaedic, Colorectal, Gynae-Oncology and Neurosurgery,  then other specialties, to formally test the apparent benefits. It adds better risk assessment and triage tools. Datasets from patient progress and vital signs are used to improve patient risk stratification and triage at defined timepoints before, during, and after surgery, allowing better and earlier identification of patients (not) needing ongoing ARRC, reducing costs further. A Markov cost-effectiveness model provides the platform for cost effectiveness outcomes (Days at Home V Cost).    
This work addresses all Principles from a recent national summit on postoperative complications - https://thehiddenpandemic.com

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Guy Ludbrook

Address

Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000

Country

Australia

Phone

+61 413817901

Fax

+61 870746146

guy.ludbrook@sa.gov.au

Contact person for public queries

Name

Guy Ludbrook

Address

Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000

Country

Australia

Phone

+61 413817901

Fax

+61 870746146

guy.ludbrook@sa.gov.au

Contact person for scientific queries

Name

Guy Ludbrook

Address

Royal Adelaide Hospital, 1 Port Rd, 3G395, Adelaide SA 5000

Country

Australia

Phone

+61 413817901

Fax

+61 870746146

guy.ludbrook@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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