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Trial registered on ANZCTR

Registration number

ACTRN12617001173381

Ethics application status

Approved

Date submitted

25/07/2017

Date registered

10/08/2017

Date last updated

24/07/2019

Date data sharing statement initially provided

24/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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?

Scientific title

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.

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1199-5932

Trial acronym

ARRC Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Patients undergoing Hartmann's procedure

Patients undergoing total hip replacement

Patients undergoing hip fracture surgery

Condition category

Condition code

Surgery

Other surgery

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Other interventions

Comparator / control treatment

The control treatment would be considered as the "before period" as standard recovery ward care is provided to eligible patients after surgery. The type of ward care delivered would be dependent on the type of surgeries and the potential complications experienced by the patients. The care provided will also be dependent on the local practices of the hospital.

Briefly, eligible patients would usually wake up in the recovery room and will be monitored by a nurse before getting transferred to the ward.

Control group

Active

Outcomes

Primary outcome [1]

This feasibility study will examine in the initial period of "Advanced Recovery Room Care" how many medium risk patients were able to participate in the study

Timepoint [1]

This will be assessed from the start to the end of the study and will be at a minimum of 14 weeks and a maximum of 18 weeks.

Primary outcome [2]

This feasibility study will examine in the initial period of "Advanced Recovery Room Care" the retention rate of patients at postoperative day 90

Timepoint [2]

Postoperative day 90

Primary outcome [3]

This feasibility study will examine in the initial period of "Advanced Recovery Room Care" the successful implementation by anaesthetists, surgeons, nurses of the Advanced Recovery Room care unit in terms of compliance with ward rounds.

This would be assessed with the number of times ward rounds were implemented for each patient enrolled during the "After period".

Timepoint [3]

This will occur during the after period post surgery and up to 24 hours in the "Advanced Recovery Room" care unit.

Secondary outcome [1]

This feasibility study will examine in the initial period of "Advanced Recovery Room Care" the successful implementation by anaesthetists, surgeons, nurses of the Advanced Recovery Room care unit in terms the use of the "Advanced Recovery Room" care unit checklist to monitor patients.

Timepoint [1]

This will occur during the after period post surgery and up to 24 hours in the "Advanced Recovery Room" care unit.

Secondary outcome [2]

The successful collection of the following outcome measures will be assessed:
i.) In hospital quality and cost:
a. Mortality
b. unexpected HDU/ICU admission
c. MET calls
d. quality of recovery (QoR-15 and brief pain index on Postoperative Day 2)
e. length of stay

Timepoint [2]

The following outcome measures will be assessed after patients have had surgery in all period of the study (before, transition and after periods).

Secondary outcome [3]

The successful collection of the following outcome measures will be assessed:
ii.) Post discharge quality and cost
a. 90-day mortality
b. days alive and out of the hospital
c. quality of life (EQ-5D on Postoperative Day 90)
d. time to return to normal activities
e. number of representations and re-admissions to hospital

Timepoint [3]

The following outcome measures will be assessed after patients have had surgery in all period of the study (before, transition and after periods).

Eligibility

Key inclusion criteria

1.) Patient predicted with 1 to 4% 30-day mortality based on ACS NSQIP surgical risk scoring (available at http://riskcalculator.facs.org/RiskCalculator/)

2.) Scheduled to undergo elective or emergency surgery requiring at least 3 days stay in hospital.

3.) Scheduled for postoperative care in the recovery room and then a general surgical ward

4.) Available for follow up at 90 days

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1.) Cardiac surgery

2.) Planned admission to ICU/HDU postoperatively

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

n/a

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

The study design is before and after therefore, patients who are scheduled to have surgeries early on (once this study has commenced for about 4 to 5 weeks ) then will most likely receive standard recovery ward care.

Dependent on the time period patients will undergo surgery, they will either receive:

a.) Standard recovery ward care
OR
b.) Advanced recovery room care for up to 24 hours after surgery and will be transferred to standard recovery ward care and a higher level of ward care if required.

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Being a feasibility study this study does not require a specific sample size. However, we anticipate that we will collect data on 480 patients that will inform the formal sample size calculation for the subsequent definitive trial of clinical effectiveness. Based on the premise that pilot sites will have units of 3 beds on average (based on a nurse to patient ratio of 1:3), and will function 4 nights per week (Mon-Thurs), four sites allow 48 patients to be studied per week.

Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals. Differences in outcome measures will be evaluated between before and after period via independent Student t tests, chi-square tests or logistic regression. The Bonferroni methods will be used to adjust the level of significance for outcome measures so the overall apha level is 0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/01/2018

Actual

9/04/2018

Date of last participant enrolment

Anticipated

15/12/2020

Actual

Date of last data collection

Anticipated

15/06/2021

Actual

Sample size

Target

480

Accrual to date

126

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Recruitment hospital [1]

Lismore Base Hospital - Lismore

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [3]

Peter MacCallum Cancer Centre - Melbourne

Recruitment postcode(s) [1]

2480 - Lismore

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

3000 - Melbourne

Recruitment postcode(s) [4]

3000 - Melbourne

Funding & Sponsors

Funding source category [1]

University

Name [1]

PARC Clinical Research, The University of Adelaide

Address [1]

Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, SA 5000

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Australian and New Zealand College of Anaesthetists

Address [2]

Ulimaroa
630 St Kilda Road
Melbourne
Vic 3000

Country [2]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (TQEH/LMH/MH)

Ethics committee address [1]

The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/05/2017

Approval date [1]

13/07/2017

Ethics approval number [1]

HREC/17/TQEH/104

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Guy Ludbrook

Address

Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000

Country

Australia

Phone

+618 7074 1544

Fax

+618 7074 6177

[email protected]

Contact person for public queries

Name

Guy Ludbrook

Address

Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000

Country

Australia

Phone

+618 7074 1544

Fax

+618 7074 6177

[email protected]

Contact person for scientific queries

Name

Louise de Prinse

Address

Level 4G109, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000

Country

Australia

Phone

+618 7074 1544

Fax

+618 7074 6177

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Providence, patient or provider? Looking for truth in retrospective database studies.	2019	https://dx.doi.org/10.1111/anae.14573

N.B. These documents automatically identified may not have been verified by the study sponsor.

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