RecruitingACTRN12617001173381

Will the use of an Advanced Recovery Room Care Unit for medium risk surgery patients provide better care and reduce hospital cost in comparison to standard Recovery Room care?

A feasibility study of a multi-centre trial of a change in practice (introduction of an Advanced Recovery Room care unit) with measurement of in-hospital and post discharge quality and cost.


Sponsor

The University of Adelaide

Enrollment

480 participants

Start Date

Apr 9, 2018

Study Type

Interventional

Conditions

Summary

We know that patients with serious illness undergoing surgery are at risk of major complications after surgery and benefit from treatment by specialists in Intensive Care and High Dependency Units. It is more recently recognised that patients with less serious medical illnesses (such as diabetes, obesity, and hypertension) undergoing certain surgery also have a high risk of life-threatening complications in general postoperative wards in the early hours after elective surgery. Recent evidence suggests that providing these patients with advanced treatment in the early hours after surgery may benefit their recovery from surgery in terms of the risk of serious complications and time to return to home and that overall health care costs may fall. It is also possible that there is a positive impact on post-discharge return to normal living, which may also positively impact on health care costs. We already have skilled medical and nursing teams in place in recovery rooms to provide very short-term advanced care for these patients, but often there is no option to continue this beyond a few hours. We propose that an anaesthesia led advanced care service based in operating suite recovery rooms can care for both the sicker patients currently being sent to the wards after surgery and the less sick of the higher risk patients currently being admitted the high dependency beds. We call this combined group of patients “medium risk” for early and late complications. To fully test this proposal we will need to conduct a large multi-million dollar randomized trial at over 20 hospitals. Before we can do that trial we need to conduct a study of the feasibility of elements of the trial. This feasibility study will examine the impact on patients and the health care system of providing advanced post-anaesthesia care with the skilled staff and facilities in recovery rooms. Formal screening of patients preoperatively, including using computer risk-assessment tools to assist clinical judgment will be tested to identify the patient group at risk. A group of these patients will receive advanced postanaesthesia care in a small number of hospitals around Australia, with careful measurement of the effect on their recovery from surgery. If the results of this feasibility study show a potential benefit to patient and the health care system, and that we can expect to complete the large randomised trial.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether keeping medium-risk surgery patients in the recovery room for advanced post-surgery care — rather than sending them to a general ward — leads to better recovery and lower hospital costs. People with conditions like diabetes, obesity, or high blood pressure who undergo certain types of surgery can be at risk of serious complications in the hours immediately after the operation. Having skilled anaesthesia staff and equipment in the recovery room may catch problems early. This is a feasibility study to see if a larger national trial is possible. You may be eligible if: - You are 18 years of age or older - Your predicted risk of dying within 30 days of surgery is between 1% and 4% (calculated using a surgical risk scoring tool) - You are scheduled for elective or emergency surgery requiring at least 3 days in hospital - You are planned for recovery room care followed by a general surgical ward - You are available for a 90-day follow-up You may NOT be eligible if: - You are having cardiac surgery - You are planned to be admitted to ICU or a high-dependency unit after surgery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study will be divided into three arms in a specific order and different interventions will be delivered at the different arms: Arm 1 Before period: Standard recovery ward care after surgery

The study will be divided into three arms in a specific order and different interventions will be delivered at the different arms: Arm 1 Before period: Standard recovery ward care after surgery - This period will be 4 to 5 weeks in duration - Eligible patients will be admitted to the recovery room and surgical ward care according to usual hospital procedures until discharge from the hospital Arm 2 Transition period: The introduction of the "Advanced Recovery Room Care" for up to 24 hours after surgery - This period will be 4 to 5 weeks in duration -Eligible patients will be admitted to the "Advanced Recovery Room Care" after surgery for up to 24 hours -Advanced Recovery Room Care will differ from the standard recovery ward care by providing short-term enhanced care to eligible patients after surgery with regular rounds of monitoring by Drs (approximately 3 hourly) and with the use of a checklist -The types of treatments received at the "Advanced Recovery Room Care" will be dependent on the complications experienced by the patients such optimising analgesic and cardio-respiratory status, and fluid management. - Eligible patients will also be assessed on the morning of Postoperative Day 1 and be transferred to the appropriate wards dependent on the patient's status Arm 3 After period:: Use of Advanced Recovery Room Care for up to 24 hours after surgery -Eligible patients will be admitted to the "Advanced Recovery Room Care" after surgery for up to 24 hours - Eligible patients will be monitored on regular rounds (approximately 3 hourly) and guided by a checklist - Eligible patients will also be assessed on the morning of Postoperative Day 1 and be transferred to the appropriate wards dependent on the patient's status


Locations(3)

Lismore Base Hospital - Lismore

NSW,QLD,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

NSW,QLD,SA,VIC, Australia

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ACTRN12617001173381