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

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.

Study Overview

• Status: Recruiting
• Conditions: Economic Problems; Post-Surgical Complication
• Intervention / Treatment: Other: ARRC; Other: Usual 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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Guy L Ludbrook, MBBS PhD; Phone Number: +61 413817901; Email: guy.ludbrook@sa.gov.au
• Study Contact Backup: Name: Kathy Heyman, RN; Phone Number: +61 8 7074 5044; Email: kathy.heyman2@sa.gov.au

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Guy L Ludbrook, MBBS PhD; Phone Number: +61413817901; Email: guy.ludbrook@sa.gov.au
      • Contact: Kathy Heyman, RN; Phone Number: +618 7074 5044; Email: kathy.heyman2@sa.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at Royal Adelaide Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medium risk patients undergoing surgery; Patients undergoing surgery designated as medium risk using NSQIP risk scores	Other: ARRC; Eligible for ARRC and managed in ARRC unit; Other: Usual Care; Eligible for ARRC but managed elsewhere as no ARRC bed available

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days at Home after surgery	number of days spent at usual place of residence within 90 days after surgery	90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital complications	medical emergency response level complications	out to 10 days after surgery
mortality	mortality out to 1 year after surgery	12 months after surgery
cost-effectiveness	cost per Day at Home improvement compared to usual care - Incremental cost-effectiveness ratio	90 days after surgery

Collaborators and Investigators

• Sponsor: University of Adelaide
• Collaborators: Royal Adelaide Hospital
• Investigators: Principal Investigator: Guy Ludbrook, MBBS PhD, Professor of Anaesthesia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): July 18, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: safety; surgery; anaesthesia; postoperative complications; quality of recovery after surgery; health economics
• Other Study ID Numbers: 17557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be available to other researchers on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No