Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001232123
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
6/09/2019
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a short message service to improve compliance with fasting in patients undergoing elective surgery
Scientific title
Effects of a short message service (SMS) by cellular phone to improve compliance with fasting guidelines in patients undergoing elective surgery
Secondary ID [1] 298918 0
None
Universal Trial Number (UTN)
U1111-1238-0453
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-operative Fasting 313906 0
Condition category
Condition code
Anaesthesiology 312319 312319 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Participants in the intervention group received an additional prompt one day prior to surgery via a short-message service (SMS) containing a reminder of fasting times, in addition to receiving fasting guidelines as per the standard hospital policy.
- The SMS was sent once only, the day prior to surgery.
- A dedicated perioperative staff member confirmed the theatre list for the following day and then the SMS was sent times to the patient’s registered mobile phone with fasting times. SMS messages were sent by staff of the pre-operative day stay unit who were aware of the study protocol.
- The SMS was in the English language, clearly articulating the fasting times for both solids and liquids.
- Morning list patients were advised to “fast from midnight for solids” and “from 06:30 for liquids”. The afternoon list patients were advised to “fast from 07:30 for solids” and “from 11:30 for liquids”. Solids were described as a “very light meal e.g. cereal or toast”. Clear fluids were described “water, clear cordial or apple juice, or black tea or black coffee with NO milk”.
Intervention code [1] 315205 0
Other interventions
Comparator / control treatment
The comparator/control was based on an audit of fasting times amongst elective surgery patients at Ballarat Health Service who received fasting guidelines as per the standard hospital policy.
Control group
Active

Outcomes
Primary outcome [1] 320953 0
Length of fasting time for solids and fluids

This outcome is assessed based on a patient questionnaire pre-operatively which was then recorded into medical records
Timepoint [1] 320953 0
Peri-operative period (day before and day of surgery)
Secondary outcome [1] 373488 0
Proportion of patients who fasted in accordance with recommended guidelines

This outcome is assessed based on a patient questionnaire pre-operatively which was then recorded into medical records
Timepoint [1] 373488 0
Peri-operative period (day before and day of surgery)

Eligibility
Key inclusion criteria
we included adult patients (>18 years) undergoing elective surgery with a day of surgery admission.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded patients undergoing emergency procedures, morbid obesity (body mass index > 35kg/m2), patients with previous gastric or bypass surgery, history of delayed gastric emptying, pregnant patients, and all inpatients.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/06/2016
Date of last participant enrolment
Anticipated
Actual
21/06/2016
Date of last data collection
Anticipated
Actual
21/06/2016
Sample size
Target
250
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14432 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 27442 0
3350 - Ballarat Central

Funding & Sponsors
Funding source category [1] 303464 0
Hospital
Name [1] 303464 0
Ballarat Health Service
Country [1] 303464 0
Australia
Primary sponsor type
Individual
Name
A/Prof Laurence Weinberg
Address
Austin Health, Department of Anaesthesia, 145 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 303518 0
None
Name [1] 303518 0
Address [1] 303518 0
Country [1] 303518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303995 0
Ballarat Health Services and St John of God Hospital Ballarat Human Research Ethics Committee
Ethics committee address [1] 303995 0
Ethics committee country [1] 303995 0
Australia
Date submitted for ethics approval [1] 303995 0
Approval date [1] 303995 0
28/01/2016
Ethics approval number [1] 303995 0
HREC/12/BHSSJOG/76

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95490 0
A/Prof Laurence Weinberg
Address 95490 0
Department of Anaesthesia
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 95490 0
Australia
Phone 95490 0
+61 3 9496 3800
Fax 95490 0
Email 95490 0
[email protected]
Contact person for public queries
Name 95491 0
Laurence Weinberg
Address 95491 0
Department of Anaesthesia
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 95491 0
Australia
Phone 95491 0
+61 3 9496 3800
Fax 95491 0
Email 95491 0
[email protected]
Contact person for scientific queries
Name 95492 0
Laurence Weinberg
Address 95492 0
Department of Anaesthesia
Austin Health
145 Studley Rd, Heidelberg VIC 3084
Country 95492 0
Australia
Phone 95492 0
+61 3 9496 3800
Fax 95492 0
Email 95492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Complete database of all de-identified participant data
When will data be available (start and end dates)?
after publication with no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
by email contact of the principal investigator - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3766Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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