Trial Review

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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] 292482 0
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 304107 0
Patients undergoing total hip replacement 304298 0
Patients undergoing hip fracture surgery 304299 0
Condition category
Condition code
Surgery 303438 303438 0 0
Other surgery
Public Health 303562 303562 0 0
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] 298661 0
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] 302862 0
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] 302862 0
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] 302863 0
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] 302863 0
Postoperative day 90
Primary outcome [3] 302864 0
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] 302864 0
This will occur during the after period post surgery and up to 24 hours in the "Advanced Recovery Room" care unit.
Secondary outcome [1] 337498 0
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] 337498 0
This will occur during the after period post surgery and up to 24 hours in the "Advanced Recovery Room" care unit.
Secondary outcome [2] 337499 0
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] 337499 0
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] 337500 0
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] 337500 0
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?
No
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] 8613 0
Lismore Base Hospital - Lismore
Recruitment hospital [2] 9633 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 11527 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 16721 0
2480 - Lismore
Recruitment postcode(s) [2] 18389 0
5000 - Adelaide
Recruitment postcode(s) [3] 23552 0
3000 - Melbourne
Recruitment postcode(s) [4] 23553 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297052 0
University
Name [1] 297052 0
PARC Clinical Research, The University of Adelaide
Country [1] 297052 0
Australia
Funding source category [2] 300265 0
Other Collaborative groups
Name [2] 300265 0
Australian and New Zealand College of Anaesthetists
Country [2] 300265 0
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] 296055 0
None
Name [1] 296055 0
Address [1] 296055 0
Country [1] 296055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298233 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 298233 0
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 298233 0
Australia
Date submitted for ethics approval [1] 298233 0
19/05/2017
Approval date [1] 298233 0
13/07/2017
Ethics approval number [1] 298233 0
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 76426 0
Prof Guy Ludbrook
Address 76426 0
Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000
Country 76426 0
Australia
Phone 76426 0
+618 7074 1544
Fax 76426 0
+618 7074 6177
Email 76426 0
[email protected]
Contact person for public queries
Name 76427 0
Prof Guy Ludbrook
Address 76427 0
Level 4G.1, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000
Country 76427 0
Australia
Phone 76427 0
+618 7074 1544
Fax 76427 0
+618 7074 6177
Email 76427 0
[email protected]
Contact person for scientific queries
Name 76428 0
Ms Louise de Prinse
Address 76428 0
Level 4G109, East Wing, Port Road, Royal Adelaide Hospital, Adelaide, SA 5000
Country 76428 0
Australia
Phone 76428 0
+618 7074 1544
Fax 76428 0
+618 7074 6177
Email 76428 0
[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
SourceTitleYear of PublicationDOI
EmbaseProvidence, patient or provider? Looking for truth in retrospective database studies.2019https://dx.doi.org/10.1111/anae.14573
N.B. These documents automatically identified may not have been verified by the study sponsor.