Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000879965
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
3/09/2020
Date last updated
3/09/2020
Date data sharing statement initially provided
3/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Survey of discharge prescribing of analgesia after surgery and Emergency Department attendance
Scientific title
Prescribing of analgesia after surgery and Emergency Department attendance, a survey of doctors’ beliefs and attitudes towards prescribing painkillers and their views on teaching of how to prescribe.
Secondary ID [1] 301503 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prescribing painkillers 317836 0
Trauma 318451 0
Post-operative pain 318452 0
Condition category
Condition code
Anaesthesiology 315892 315892 0 0
Pain management
Emergency medicine 316102 316102 0 0
Other emergency care
Public Health 316103 316103 0 0
Health service research
Public Health 316104 316104 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Survey questions on discharge prescribing of analgesia after surgery and Emergency Department (ED) attendance will be distributed electronically via email by project members to departmental directors, for the latter to distribute to Resident Medical Officers (RMOs), consultants and specialist trainees. Electronic information sheets and consent forms will be given in the same email. The survey will be done once only per participant within Royal Brisbane Women's Hospital (RBWH) and Townsville University Hospital (TUH), and survey results will be collated 3-4 months after distribution for analysis by project members.

The survey content includes types of drug prescribed, dosage range prescribed, opinions on prescribing, confidence of prescribing, sites of teaching; and the survey format will be in multiple choice where more than one option can be selected, and free text option. The approximate duration to complete the survey is less than 5 minutes and participants are given 2 weeks to complete the survey, with results being collated by December 2020.
Intervention code [1] 317808 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324103 0
Residents Medical Officers' views on prescribing analgesia will be assessed using a study-specific questionnaire, and compared to Queensland Health guidelines for analgesic prescribing
Timepoint [1] 324103 0
Baseline
Primary outcome [2] 324609 0
Consultants and Specialist Trainees views on prescribing analgesia will be assessed using a study-specific questionnaire, and compared to Queensland Health guidelines for analgesic prescribing
Timepoint [2] 324609 0
Baseline
Secondary outcome [1] 385297 0
Residents Medical Officers' perception on teaching of analgesia prescribing will be assessed using a study-specific questionnaire
Timepoint [1] 385297 0
Baseline
Secondary outcome [2] 385298 0
Consultants and Specialist Trainees' perception on teaching of analgesia prescribing will be assessed using a study-specific questionnaire
Timepoint [2] 385298 0
Baseline

Eligibility
Key inclusion criteria
The study will include RMOs, Specialist Trainees and Consultants in RBWH or TUH working in the following fields:
• Emergency Department, or
• Ear, Nose and Throat Surgery
• Cardiothoracic Surgery, or
• General Surgery, or
• Vascular Surgery, or
• Maxillofacial Surgery, or
• Neurosurgery, or
• Obstetrics and Gynaecology, or
• Ophthalmology, or
• Orthopaedics, or
• Paediatric Surgery
• Colorectal Surgery, or
• Urology.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/09/2020
Actual
Date of last participant enrolment
Anticipated
10/12/2020
Actual
Date of last data collection
Anticipated
10/12/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16895 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 16896 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 30546 0
4814 - Douglas
Recruitment postcode(s) [2] 30547 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 306120 0
Self funded/Unfunded
Name [1] 306120 0
Unfunded - this research will be carried out in investigators' own time.
Country [1] 306120 0
Primary sponsor type
Individual
Name
Dr Stephen Gilbert
Address
Medilink Building, Townsville University Hospital, 100 Angus Smith Dr, Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 306589 0
None
Name [1] 306589 0
Address [1] 306589 0
Country [1] 306589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306186 0
Townsville Hospital and Health Service - Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 306186 0
Townsville University Hospital, 100 Angus Smith Dr, Douglas QLD 4814
Ethics committee country [1] 306186 0
Australia
Date submitted for ethics approval [1] 306186 0
29/05/2020
Approval date [1] 306186 0
11/06/2020
Ethics approval number [1] 306186 0

Summary
Brief summary
Survey of discharge prescribing of analgesia after surgery and Emergency Department (ED) attendance is a study designed to target Resident Medical Officers (RMOs), Specialist Trainees and Consultants in Royal Brisbane and Women's Hospital (RBWH) and Townsville University Hospital (TUH).

This study seeks to understand the attitudes behind prescribing analgesia by doctors in specific clinical settings, to allow policy makers make targeted interventions with regards to opioid-prescribing. We hypothesise that there may be varying levels of understanding and confidence with regards to analgesia prescribing after surgery and in ED. There may also be differences in teaching, guidance and supervision, provided for RMOs.

The survey will be distributed electronically to doctors in RBWH and TUH working in Emergency Department or Surgical Departments (including General Surgery, Cardiothoracic Surgery, Vascular Surgery, Neurosurgery, Orthopaedics, Colorectal Surgery, Urology and Gynaecology) for participants to fill in anonymously. Survey results will be analysed by project members for publication in a peer reviewed journal, presented as a poster at scientific meetings and used by local clinical leads to inform the development of targeted interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103014 0
Dr Stephen Gilbert
Address 103014 0
Townsville University Hospital, Medilink Building, 100 Angus Smith Dr, Douglas QLD 4814
Country 103014 0
Australia
Phone 103014 0
+61 07 4433 5300
Fax 103014 0
Email 103014 0
[email protected]
Contact person for public queries
Name 103015 0
Dr Stephen Gilbert
Address 103015 0
Townsville University Hospital, Medilink Building, 100 Angus Smith Dr, Douglas QLD 4814
Country 103015 0
Australia
Phone 103015 0
+61 07 4433 5300
Fax 103015 0
Email 103015 0
[email protected]
Contact person for scientific queries
Name 103016 0
Dr Stephen Gilbert
Address 103016 0
Townsville University Hospital, Medilink Building, 100 Angus Smith Dr, Douglas QLD 4814
Country 103016 0
Australia
Phone 103016 0
+61 07 4433 5300
Fax 103016 0
Email 103016 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
Survey responses are anonymous to encourage higher response rate, truthful responses and protecting of confidentiality, as questions are sensitive and survey is distributed within the hospital.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.