Post-Surgical ComplicationARRCIIINCT05836285
The ARRC III Trial of Advanced Recovery Room Care (ARRC).
An observational study of Post-Surgical Complication and Economic Problems, run by University of Adelaide at 1 site in Australia.
Trial summary
A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Surgical Complication, Economic Problems
- What is being tested?
- ARRC
- How many people
- 3,000 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Apr 2023to Dec 2025
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery at Royal Adelaide Hospital
Who may be able to join
- Scheduled for elective or unplanned surgery
- Scheduled to stay in hospital at least one night after surgery
- 30-day mortality of 0.5% to 8% by the US National Safety and Quality Improvement Program risk score (NSQIP)
Who cannot join
- Undergoing cardiac surgery
- Scheduled for postoperative Intensive Care Unit management
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Guy L Ludbrook, MBBS PhD, +61413817901, guy.ludbrook@sa.gov.au
Kathy Heyman, RN, +618 7074 5044, kathy.heyman2@sa.gov.au
About this study
A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023).
The goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -ARRC and usual ward care. The main questions it aims to answer are:
what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.
Read the detailed description
Demand for essential surgery is growing, yet we face an increasingly complex casemix and budget challenges. New paradigms to deliver high value care are essential.
Advanced Recovery Room Care (ARRC) is a model of care which, at RAH, has been shown to provide substantial improvements in patient outcomes, hospital utilisation, and costs of care. Specifically, it showed when compared to usual ward care: improved Days at Home after Surgery (primary outcome), decreased in-hospital complications, and decreased mortality at 1, 3 and 12 months. This model was cost-effective compared to usual ward care: ICER of approximately -$250 per DAH
It is essential to collect high quality data on this model relevant to consumers and hospitals, in order to:
- provide a robust mechanism to ensure outcomes are maintained, and ideally improved, within our institution
- provide a mechanism to potentially allow benchmarking in the future, across institutions
- better identify which surgical subgroups receive benefit from ARRC
- provide a resource to generate and test hypotheses as to how these benefits are achieved.
To that end, the ARRC II study database is to be refined to function in essence as an ongoing registry.
This will be initially piloted at RAH, the subject of this study.
- Conditions
- Post-Surgical Complication, Economic Problems
- Being tested
- ARRC, Usual Care
- Keywords
- postoperative complications, safety, health economics, quality of recovery after surgery, surgery, anaesthesia
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRCOther
Eligible for ARRC and managed in ARRC unit
Usual CareOther
Eligible for ARRC but managed elsewhere as no ARRC bed available
| Study group | Role | What they receive |
|---|---|---|
| Medium risk patients undergoing surgery | Patients undergoing surgery designated as medium risk using NSQIP risk scores Receives: Other: ARRC; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days at Home after surgery
number of days spent at usual place of residence within 90 days after surgery
Measured: 90 days after surgery
Secondary outcomes (3)
in-hospital complications
medical emergency response level complications
Measured: out to 10 days after surgery
mortality
mortality out to 1 year after surgery
Measured: 12 months after surgery
cost-effectiveness
cost per Day at Home improvement compared to usual care - Incremental cost-effectiveness ratio
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start18 Apr 2023
- Primary completion18 Jul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Surgical ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Adelaide Hospital
- Responsible party
- Principal investigator, Guy Ludbrook, University of Adelaide
- Investigators
- Guy Ludbrook, MBBS PhD, Principal investigator, Professor of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836285
- Sponsor's protocol ID
- 17557
- Acronym
- ARRCIII
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available to other researchers on request
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.
PubMed 33027534
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ARRC III Trial of Advanced Recovery Room Care (ARRC).
- ClinicalTrials.gov ID
- NCT05836285
- Acronym / sponsor ID
- ARRCIII / 17557
- Conditions
- Post-Surgical Complication, Economic Problems
- Keywords
- postoperative complications, safety, health economics, quality of recovery after surgery, surgery, anaesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Royal Adelaide Hospital
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 18 Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023).
The goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -ARRC and usual ward care. The main questions it aims to answer are:
what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.
Detailed description
Demand for essential surgery is growing, yet we face an increasingly complex casemix and budget challenges. New paradigms to deliver high value care are essential.
Advanced Recovery Room Care (ARRC) is a model of care which, at RAH, has been shown to provide substantial improvements in patient outcomes, hospital utilisation, and costs of care. Specifically, it showed when compared to usual ward care: improved Days at Home after Surgery (primary outcome), decreased in-hospital complications, and decreased mortality at 1, 3 and 12 months. This model was cost-effective compared to usual ward care: ICER of approximately -$250 per DAH
It is essential to collect high quality data on this model relevant to consumers and hospitals, in order to:
- provide a robust mechanism to ensure outcomes are maintained, and ideally improved, within our institution
- provide a mechanism to potentially allow benchmarking in the future, across institutions
- better identify which surgical subgroups receive benefit from ARRC
- provide a resource to generate and test hypotheses as to how these benefits are achieved.
To that end, the ARRC II study database is to be refined to function in essence as an ongoing registry.
This will be initially piloted at RAH, the subject of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medium risk patients undergoing surgery | – | Other: ARRC, Other: Usual CarePatients undergoing surgery designated as medium risk using NSQIP risk scores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery at Royal Adelaide Hospital
Key inclusion criteria (3 listed)
- Scheduled for elective or unplanned surgery
- Scheduled to stay in hospital at least one night after surgery
- 30-day mortality of 0.5% to 8% by the US National Safety and Quality Improvement Program risk score (NSQIP)
Key exclusion criteria (2 listed)
- Undergoing cardiac surgery
- Scheduled for postoperative Intensive Care Unit management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARRCEligible for ARRC and managed in ARRC unit | Other | Medium risk patients undergoing surgery |
| Usual CareEligible for ARRC but managed elsewhere as no ARRC bed available | Other | Medium risk patients undergoing surgery |
Primary outcome
Days at Home after surgery
Time frame: 90 days after surgery
number of days spent at usual place of residence within 90 days after surgery
3 secondary outcomes
in-hospital complications
Time frame: out to 10 days after surgery
mortality
Time frame: 12 months after surgery
cost-effectiveness
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Results publication: PubMed 33027534Ludbrook 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.
- Individual participant dataSharing planned: Undecided. Data may be available to other researchers on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Ludbrook, MBBS PhD principal investigator
Professor of Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Surgical Complication and Economic Problems, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy L Ludbrook, MBBS PhD (+61 413817901, guy.ludbrook@sa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days at Home after surgery (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.