NCT05836285

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

April 18, 2023

Last Update Submit

August 11, 2024

Conditions

Keywords

postoperative complicationssafetyhealth economicsquality of recovery after surgerysurgeryanaesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • in-hospital complications

    out to 10 days after surgery

  • mortality

    12 months after surgery

  • cost-effectiveness

    90 days after surgery

Study Arms (1)

Medium risk patients undergoing surgery

Patients undergoing surgery designated as medium risk using NSQIP risk scores

Other: ARRCOther: Usual Care

Interventions

ARRCOTHER

Eligible for ARRC and managed in ARRC unit

Medium risk patients undergoing surgery

Eligible for ARRC but managed elsewhere as no ARRC bed available

Medium risk patients undergoing surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery at Royal Adelaide Hospital

You may qualify if:

  • Scheduled for elective or unplanned surgery
  • Scheduled to stay in hospital at least one night after surgery
  • day mortality of 0.5% to 8% by the US National Safety and Quality Improvement Program risk score (NSQIP)

You may not qualify if:

  • Undergoing cardiac surgery
  • Scheduled for postoperative Intensive Care Unit management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guy Ludbrook, MBBS PhD

    Professor of Anaesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy L Ludbrook, MBBS PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anaesthesia

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 1, 2023

Study Start

April 18, 2023

Primary Completion

July 18, 2025

Study Completion

December 1, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations