The ARRC III Trial of Advanced Recovery Room Care (ARRC). | NCT05836285

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

NCT05836285

Sponsor

University of Adelaide

Status

Recruiting

Last Update Posted

Aug 14, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Post-Surgical Complication
Economic Problems

Interventions

ARRC
Usual Care

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2023Actual

Primary Completion Date

Jul 18, 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2024

Last Update Posted Date

Aug 14, 2024Actual

Name	Class
Royal Adelaide Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medium risk patients undergoing surgery		Patients undergoing surgery designated as medium risk using NSQIP risk scores	Other: ARRC Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARRC	Other	Eligible for ARRC and managed in ARRC unit	Medium risk patients undergoing surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing surgery at Royal Adelaide Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guy L Ludbrook, MBBS PhD	Contact	+61 413817901		guy.ludbrook@sa.gov.au
Kathy Heyman, RN	Contact	+61 8 7074 5044		kathy.heyman2@sa.gov.au

Overall Officials

Name	Affiliation	Role
Guy Ludbrook, MBBS PhD	Professor of Anaesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Adelaide Hospital	Recruiting	Adelaide	South Australia	5000	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33027534	Result	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms