Postoperative Complications Clinical Trial
— ARRCIIOfficial title:
Advanced Recovery Room Care - an Iterative Model to Improve Outcomes and Reduce Cost in Perioperative Care
NCT number | NCT04769518 |
Other study ID # | 381293 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | March 24, 2022 |
Verified date | March 2022 |
Source | University of Adelaide |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Moderate-risk surgical patients have a very high incidence of early serious postoperative complications (approximately 50% at Royal Adelaide Hospital, RAH). This affects patients' wellbeing and produces a high rate of unplanned postoperative hospital re-admissions. This is also costly, and patients unnecessarily fill approximately 4000 RAH bed days annually. A trial of a new model of enhanced care after surgery (Advanced Recovery Room Care, 'ARRC') demonstrated that complications were quickly identified and expertly addressed. Re-admission days appeared to decrease by 80%. Business and economic analysis showed (i) patients can expect 3 extra days at home, (ii) 4000 bed days can be freed annually, and (iii) better care at lesser cost (technically, ICER = -$600/day at home). Freeing hospital beds, and rapid cost savings, are critical in this Covid era. This trial re-introduces ARRC for Orthopaedic, Colorectal, Gynae-Oncology and Neurosurgery, and other specialties, and formally examines patient outcomes and costs compared to eligible patient who do not receive ARRC. Data from patient progress and vital signs are to be used to improve patient risk stratification and triage at defined timepoints before, during, and after surgery. This may allow better and earlier identification of patients (not) needing ongoing ARRC, potentially reducing costs of care further without affecting safety. A Markov cost-effectiveness model provides the platform for cost effectiveness outcomes (Days at Home V Cost).
Status | Terminated |
Enrollment | 857 |
Est. completion date | March 24, 2022 |
Est. primary completion date | March 24, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Scheduled for elective or emergency surgery - American College of Surgeons NSQIP-predicted 30-day mortality of 0.7-5% - Expected inpatient postoperative stay at least 2 nights Exclusion Criteria: - Cardiac and thoracic surgery - Scheduled for Intensive Care management postoperatively |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Lead Sponsor | Collaborator |
---|---|
University of Adelaide | Central Adelaide Local Health Network Incorporated, University of Southampton |
Australia,
Lloyd C, Proctor L, Au M, Story D, Edwards S, Ludbrook G. Incidence of early major adverse events after surgery in moderate-risk patients: early postoperative adverse events. Br J Anaesth. 2020 Jan;124(1):e9-e10. doi: 10.1016/j.bja.2019.10.002. Epub 2019 — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days at Home | Number of days out of hospital | at 30 after surgery | |
Primary | Days at Home | Number of days out of hospital | at 90 days after surgery | |
Secondary | Cost-effectiveness | Incremental cost effectiveness ratio (ICER): days at home versus hospital costs | at 30 days | |
Secondary | Cost-effectiveness | Incremental cost effectiveness ratio (ICER): days at home versus hospital costs | at 30 days after surgery | |
Secondary | Cost-effectiveness | Incremental cost effectiveness ration (ICER): days at home versus hospital costs | at 90 days after surgery |
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