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

Sponsor
University of Adelaide (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05836285
Collaborator
Royal Adelaide Hospital (Other)
3,000
1
20
149.7

Study Details

Study Description

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 (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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The ARRC III Trial of Advanced Recovery Room Care (ARRC). A Pilot Registry at RAH
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Days at Home after surgery [90 days after surgery]

      number of days spent at usual place of residence within 90 days after surgery

    Secondary Outcome Measures

    1. in-hospital complications [out to 10 days after surgery]

      medical emergency response level complications

    2. mortality [12 months after surgery]

      mortality out to 1 year after surgery

    3. cost-effectiveness [90 days after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Adelaide Hospital Adelaide South Australia Australia 5000

    Sponsors and Collaborators

    • University of Adelaide
    • Royal Adelaide Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy Ludbrook, Professor of Anaesthesia, University of Adelaide
    ClinicalTrials.gov Identifier:
    NCT05836285
    Other Study ID Numbers:
    • 17557
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guy Ludbrook, Professor of Anaesthesia, University of Adelaide

    Study Results

    No Results Posted as of May 1, 2023