Advanced Recovery Room Care II - Improved Recovery After Surgery

NCT04769518 | Terminated DMC

• 1 other identifier: 381293
• Study Type: interventional
• Target: 857
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Complications; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (2)

• Days at Home

  Number of days out of hospital

  at 30 after surgery

• Days at Home

  Number of days out of hospital

  at 90 days after surgery

Secondary Outcomes (3)

• Cost-effectiveness

  at 30 days

• Cost-effectiveness

  at 30 days after surgery

• Cost-effectiveness

  at 90 days after surgery

Study Arms (2)

Advanced Recovery Room Care (ARRC)

ACTIVE COMPARATOR

Patients are provided with high acuity care from arrival in Recovery (PACU) until the morning after surgery. This includes higher than normal nursing ratios (1:2), regular frequent rounds by specialist anaesthetic staff, and access to monitoring and medicines (eg vasopressor infusions) not available on normal postoperative surgical wards.

Procedure: Advanced Recovery Room Care (ARRC)

Usual care

PLACEBO COMPARATOR

Patients are managed in Recovery (PACU), then normal postoperative surgical wards, as per usual care.

Procedure: Advanced Recovery Room Care (ARRC)

Interventions

Advanced Recovery Room Care (ARRC) PROCEDURE

High acuity care

Advanced Recovery Room Care (ARRC); Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiac and thoracic surgery
• Scheduled for Intensive Care management postoperatively

Sponsors & Collaborators

• University of Adelaide: lead
• University of Southampton: collaborator
• Central Adelaide Local Health Network Incorporated: collaborator

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (2)

• 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.

  PMID: 33027534 RESULT

• 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 Nov 6. No abstract available.

  PMID: 31706578 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Ludbrook, MD PhD

  Central Adelaide Local Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study - patients and staff are aware of whether treatment is provided by the ARRC model or standard recovery room then ward care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Model Details: Patients are allocated to ARRC or standard care. Allocation is based on bed availability, which has not produced group bias in the past. Matching techniques will be used if needed.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 24, 2021
• Study Start: March 1, 2021
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)