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Recruiting NCT05836285

The ARRC III Trial of Advanced Recovery Room Care (ARRC).

— Observational Post-Surgical Complication Economic Problems

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARRC, Usual Care.
Who it may be relevant to
Registry conditions: Post-Surgical Complication, Economic Problems. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other ARRC
    Eligible for ARRC and managed in ARRC unit
  • Other Usual Care
    Eligible for ARRC but managed elsewhere as no ARRC bed available

Primary outcome measures

  • Days at Home after surgery [Time frame: 90 days after surgery]
Secondary outcome measures (3)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Royal Adelaide Hospital — Adelaide

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. PMID 33027534

Identifiers

NCT: NCT05836285 · 17557

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗