The ARRC III Trial of Advanced Recovery Room Care (ARRC). A Pilot Registry at RAH (ARRCIII)

April 18, 2023 updated by: Guy Ludbrook, University of Adelaide

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 (in press).

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

Not yet recruiting

Conditions

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 (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 at Royal Adelaide Hospital 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Collaborators

Royal Adelaide Hospital

Investigators

  • Principal Investigator: Guy Ludbrook, MBBS PhD, Professor of Anaesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

December 1, 2024

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)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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