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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05836285
Other study ID # 17557
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2023
Est. completion date December 2024

Study information

Verified date April 2023
Source University of Adelaide
Contact Guy L Ludbrook, MBBS PhD
Phone +61 413817901
Email guy.ludbrook@sa.gov.au
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date December 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia

Sponsors (2)

Lead Sponsor Collaborator
University of Adelaide Royal Adelaide Hospital

Country where clinical trial is conducted

Australia, 

References & 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;7 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Days at Home after surgery number of days spent at usual place of residence within 90 days after surgery 90 days after surgery
Secondary in-hospital complications medical emergency response level complications out to 10 days after surgery
Secondary mortality mortality out to 1 year after surgery 12 months after surgery
Secondary cost-effectiveness cost per Day at Home improvement compared to usual care - Incremental cost-effectiveness ratio 90 days after surgery
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