Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000199617
Ethics application status
Approved
Date submitted
18/12/2013
Date registered
25/02/2014
Date last updated
9/12/2020
Date data sharing statement initially provided
9/12/2020
Date results information initially provided
9/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A system of perioperative assessment and management - a new Model of Care
Scientific title
For patients requiring preoperative assessment by medical and allied health staff prior to elective surgery, can a phone-based computer-assisted questionnaire, as compared to a hospital outpatient visit, in theory, provide sufficient information to obviate the need for a face to face preoperative assessment in the future?
Secondary ID [1] 283806 0
Nil
Universal Trial Number (UTN)
U1111-1151-5256
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoperative screening 290782 0
Condition category
Condition code
Anaesthesiology 291149 291149 0 0
Other anaesthesiology
Public Health 291244 291244 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A phone questionnaire is conducted to assess current medical conditions.

A phone call is made to a patient scheduled for upcoming elective surgery. A phone operator takes the patient through a series of questions and (largely tick box) answer options. The questions are generated by a computer-based smart questionnaire. It takes around 15-20 minutes.

The responses are then reviewed by an anaesthetist, and a follow up phone call is then made, if there are residual queries.

In this trial, patients undergo both telephone and face to face assessment. Face to face outpatient assessment occurs within one month of conduct of the quesionnaire.

If successful, face to face outpatient assessment may be unnecessary for some patients, but this is beyond the scope of this trial.
Intervention code [1] 288491 0
Early detection / Screening
Comparator / control treatment
Conventional face to face outpatient preoperative assessment is conducted according to current practice by anaesthetists and nursing staff rostered to the clinics. These outpatient sessions currently take between 3 and 4 hours, excluding travel time.
Control group
Active

Outcomes
Primary outcome [1] 291137 0
Outcome is assessed by reviewing eletronic and outpatient summaries together.

1. Clinicians treating the patient on the day of surgery providing comment on any missing or incomplete data in the electornic summary compared to the face to face assessment.

2. A panel of anaesthetists will also provide a similar assessment, using a 3 point 'importance' scale for missing/incorrect data - see Grant et al., 2012
Timepoint [1] 291137 0
Within 1 month of questionnaire
Secondary outcome [1] 306100 0
The anaesthetist treating the patient on the day of surgery is asked if the electronic summary would have sufficed for anaesthesa to proceed that day - Yes/No
Timepoint [1] 306100 0
The assessment by the clinician on the day of surgery occurs within 1 month of the phone questionnaire

Eligibility
Key inclusion criteria
Scheduled for elective surgery within 2-20 weeks.

Aged greater than or equal to 18 years.

Good English comprehension.

Have the capacity to answer questions about own health
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged < 18 years.

Not consenting to participate.

Non-English speaking.

Do not have capacity to answer questions about own health.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients scheduled for elective surgery meeting the inclusion criteria can be approached to participate.

Selection is at the discretion of clinic staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subjects receive both assessments - phone and face to face. Phone assessment always precedes face to face assessment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
2/06/2015
Actual
30/11/2013
Date of last data collection
Anticipated
Actual
30/11/2013
Sample size
Target
200
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1869 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 1871 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 2118 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7653 0
5011 - Woodville
Recruitment postcode(s) [2] 7654 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 7810 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 288464 0
Hospital
Name [1] 288464 0
SA Health - Northern Adelaide Local Health Network
LMHS
Country [1] 288464 0
Australia
Funding source category [2] 288465 0
University
Name [2] 288465 0
University of Adelaide
Country [2] 288465 0
Australia
Funding source category [3] 288539 0
Hospital
Name [3] 288539 0
SA Health - Central Adelaide Local Health Service
TQEH
Country [3] 288539 0
Australia
Funding source category [4] 288769 0
Hospital
Name [4] 288769 0
SA Health - Central Adelaide Local Health Service
RAH
Country [4] 288769 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Health Service
Address
Haydown Road,
Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 287167 0
University
Name [1] 287167 0
University of Adelaide
Address [1] 287167 0
North Terrace,
Adelaide, SA 5005
Country [1] 287167 0
Australia
Secondary sponsor category [2] 287467 0
Hospital
Name [2] 287467 0
The Queen Elizabeth Hospital
Address [2] 287467 0
28 Woodville Rd,
Woodville, SA 5011
Country [2] 287467 0
Australia
Secondary sponsor category [3] 287468 0
Hospital
Name [3] 287468 0
Royal Adelaide Hospital
Address [3] 287468 0
North Terrace,
Adelaide, SA 5001
Country [3] 287468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290333 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 290333 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 290333 0
Australia
Date submitted for ethics approval [1] 290333 0
Approval date [1] 290333 0
20/09/2012
Ethics approval number [1] 290333 0
HREC/12/TQEHLMH/90
Ethics committee name [2] 290608 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 290608 0
Level 3, Hanson Institute
RAH
North Terrace,
Adelaide, SA 5001
Ethics committee country [2] 290608 0
Australia
Date submitted for ethics approval [2] 290608 0
Approval date [2] 290608 0
Ethics approval number [2] 290608 0
130420

Summary
Brief summary
Currently, patients are required to attend outpatient clinics for face to face assessment of medical conditions by clinical staff prior to elective surgery.

It is hypothesised that a computer-assisted smart questionnaire, delivered by phone, will provide information of sufficient quality to allow patients to be assessed by clinicians on the day of surgery, rather than at a separate preoperative hospital visit.

A three phase approach to piloting this new process for preoperative assessment is proposed as follows:

Phase 1: Phone screening in parallel with standard outpatients visits at LMHS and TQEH. Call centre data marked but not used for patient treatment.

Phase 2: Prospective trial of a total of 1,000 patients at TQEH and the RAH. All patients will attend a streamlined outpatient clinic after phone pre-screening

Phase 3: A further 1,000 patients at TQEH and the RAH will be screened by telephone and then triaged to either a streamlined outpatient review or bypass out patinet review and assessed by the anaesthetist on day of surgery.

In all cases treating anaesthetists will be asked to mark the pre-assessements for errors or omissions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45126 0
Prof Guy Ludbrook
Address 45126 0
Anaesthesia, Royal Adelaide Hospital
North Terrace, Adelaide, South Australia 5000
Country 45126 0
Australia
Phone 45126 0
+61 870741293
Fax 45126 0
+61 8 8222 5887
Email 45126 0
[email protected]
Contact person for public queries
Name 45127 0
Guy Ludbrook
Address 45127 0
Anaesthesia, Royal Adelaide Hospital
North Terrace,
Adelaide, South Australia 5000
Country 45127 0
Australia
Phone 45127 0
+61 8 8222 5422
Fax 45127 0
+61 8 8222 5887
Email 45127 0
[email protected]
Contact person for scientific queries
Name 45128 0
Guy Ludbrook
Address 45128 0
Anaesthesia, Royal Adelaide Hospital
North Terrace,
Adelaide, South Australia 5000
Country 45128 0
Australia
Phone 45128 0
+61 870741293
Fax 45128 0
+61 8 8222 5887
Email 45128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data are available in the literature


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ludbrook et al. BMC Anesthesiology (2015) 15:77 DO... [More Details] 365517-(Uploaded-24-07-2020-09-52-26)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA call centre and extended checklist for pre-screening elective surgical patients – a pilot study2015https://doi.org/10.1186/s12871-015-0057-1
N.B. These documents automatically identified may not have been verified by the study sponsor.