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NCT Number: NCT05836285

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARRC

Other

Eligible for ARRC and managed in ARRC unit

Usual Care

Other

Eligible for ARRC but managed elsewhere as no ARRC bed available

Primary outcomes

  1. 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

Secondary outcomes

  1. in-hospital complications

    Time frame: out to 10 days after surgery

    medical emergency response level complications

  2. mortality

    Time frame: 12 months after surgery

    mortality out to 1 year after surgery

  3. cost-effectiveness

    Time frame: 90 days after surgery

    cost per Day at Home improvement compared to usual care - Incremental cost-effectiveness ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Guy L Ludbrook, MBBS PhD

CONTACT

[email protected]

+61 413817901

Kathy Heyman, RN

CONTACT

[email protected]

+61 8 7074 5044

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Collaborators

  • Royal Adelaide Hospital

Registry information

Acronym: ARRCIII

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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