Clinical trial NCT05836285: The ARRC III Trial of Advanced Recovery Room Care (ARRC).
Official title: The ARRC III Trial of Advanced Recovery Room Care (ARRC).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Surgical Complication
Economic Problems
Keywords: postoperative complications
safety
health economics
quality of recovery after surgery
surgery
anaesthesia
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Royal Adelaide Hospital
First posted: 2023-05-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery at Royal Adelaide Hospital

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Undergoing cardiac surgery
* Scheduled for postoperative Intensive Care Unit management

Primary outcomes:
measure: Days at Home after surgery
timeFrame: 90 days after surgery
Secondary outcomes:
measure: in-hospital complications
timeFrame: out to 10 days after surgery
measure: mortality
timeFrame: 12 months after surgery
measure: cost-effectiveness
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Professor of Anaesthesia
name: Guy Ludbrook, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.