Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000727943
Ethics application status
Approved
Date submitted
2/06/2020
Date registered
13/07/2020
Date last updated
13/07/2020
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PUnCQ; Pain Understanding and Confidence in undergraduate Healthcare Professional Students and General Practitioners in Australia.
Scientific title
PUnCQ; Pain Understanding and Confidence in undergraduate Healthcare Professional Students and General Practitioners in Australia.
Secondary ID [1] 301430 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-8606
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Persistent Pain 317720 0
Condition category
Condition code
Anaesthesiology 315792 315792 0 0
Pain management
Public Health 315983 315983 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a quantitative and qualitative, questionnaire study. An online survey tool will be used to gather information using the Pain Understanding and Confidence Questionnaire (PUnCQ) (Seenan et al 2017) which will be processed and analysed.
The PUnCQ questionnaire has 3 parts. The first is a multiple choice quiz on components of the International Association for the Study of Pain (IASP), undergraduate curriculum, related to a case scenario of a patient who has developed widespread chronic pain. The second section asks participants to rate their confidence in areas of the curriculum and the last section asks whether participants feel that they had enough information from their undergraduate training to be able to confidently manage persistent pain.
Participants will be contacted by email and provided with a link to the online questionnaires; (https://stephengilbert989146.typeform.com/to/YDAM1q for students and https://stephengilbert989146.typeform.com/to/hFeKEV for GP's). Once they have reviewed the information sheet and provided informed consent, if they wish to take part they will click on the link and complete the questionnaire which should take no more than 5 minutes. They will then exit the study.
The survey will also be publicised to students through representative bodies such as the Australian Medical Students Association, Australian Physiotherapy Association and Australian Psychological Association. Students will also be emailed directly by course organisers who are willing for their students to be contacted about the study.
The study will be puclicised to GPs through the RACGP and they will also be emailed directly through GP Liaison Officers who are willing to send the information on.
Ethical and legal practice will be followed, and all of the information gathered will be handled in confidence. All responses will be treated in confidence and no personal details will be stored. No identifying information will appear in any documents or in the final report.
Reference;
Seenan, C. et al 2017. PUnCQ; Knowledge and confidence related to pain management of pre-registration healthcare profession students in Scotland. Poster presented at the Scottish Pain Research Community (SPaRC) Annual Scientific Meeting, 24th March 2017 Dundee, Scotland
Intervention code [1] 317739 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323996 0
Healthcare students and General practitioners knowledge of pain management principles.
Assessed by percentage of correct and incorrect answers to 12 multiple choice questions, relating to the IASP undergraduate curriculum.
Timepoint [1] 323996 0
31 October 2020
Cumulative participant responses will be assessed at the end of the study in October 2020.
Primary outcome [2] 323997 0
Participants' confidence in aspects of pain management.
Assessed by participants self rating on 19 subjects in the IASP curriculum on a 10 point Likert scale from 1 - "not at all confident" to 10 - "no problem".
Timepoint [2] 323997 0
31.10.2020.
Cumulative participant responses will be assessed at the end of the study in October 2020.
Primary outcome [3] 324186 0
Participants' perception of whether, from their undergraduate education, they had enough information to allow them to feel comfortable in managing persistent pain? This will be a yes/no choice in answer to the question; :"From your undergraduate education, do you feel you had enough information to allow you to feel comfortable in Managing this lady's pain."
Timepoint [3] 324186 0
31.10.2020.
Cumulative participant responses will be assessed at the end of the study in October 2020.
Secondary outcome [1] 383521 0
Comparison of knowledge, between students of different health disciplines and between GP's in rural and urban practice and of different lengths of practice as a GP. This will be assessed by correct and incorrect answers to Pain Understanding and Confidence Questionnaire (PUnCQ) (Seenan et al 2017),
Timepoint [1] 383521 0
31.10.2020
Cumulative participant responses will be assessed at the end of the study in October 2020
Secondary outcome [2] 383963 0
Comparison of participants confidence between students of different health disciplines and between GP's in rural and urban practice and of different lengths of practice as a GP. Confidence ratings, from 0; not at all confident to 10; completely confident are included in the Pain Understanding and Confidence Questionnaire (PUnCQ) (Seenan et al 2017)
Timepoint [2] 383963 0
31.10.2020
Cumulative participant responses will be assessed at the end of the study in October 2020
Secondary outcome [3] 383964 0
Whether participants feel undergraduate pain management education is adequate between students of different health disciplines and between GP's in rural and urban practice and of different lengths of practice as a GP.,This will be a yes/no choice in answer to the question; :"From your undergraduate education, do you feel you had enough information to allow you to feel comfortable in Managing this lady's pain."
Timepoint [3] 383964 0
31.10.2020
Cumulative participant responses will be assessed at the end of the study in October 2020

Eligibility
Key inclusion criteria
All pre-registration healthcare profession students at Australian Universities. All students who have a role in assessing and treating pain will be approached to complete this study including medical, dentistry, nursing, midwifery, psychology, and all allied health science students. All GPs registered with the RACGP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Australian University students who are not enrolled in a degree with a healthcare profession. Doctors who are not registered with the RACGP.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size > 10,000 , based on previous experience of 12% response to online survey. In Australia there are 3,800 medical students, approximately 100,000 nursing and midwifery students, 9,000 physiotherapy students, 8,000 occupational therapy students and 5,000 psychology students = 125,800. plus 41,000 members of RACGP. - total of 166,800 potential participants.
Parametric and non-parametric statistics to examine and compare overall and between group scores for knowledge, confidence and attitudes. Qualitative analysis of comments to identify themes.
Knowledge scores will be statistically analysed for correlation and significant differences between groups using the Chi-squared test.
Confidence ratings will be statistically analysed for correlation and significant differences between groups using Spearman rank correlation coefficient and t test.
Participants answer as to whether undergraduate education was enough to enable them to manage this lady's pain - data will be statistically analysed for correlation and significant differences between groups using the Chi-squared test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
Date of last participant enrolment
Anticipated
28/08/2020
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16827 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 30450 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 305869 0
Self funded/Unfunded
Name [1] 305869 0
Stephen Gilbert
Country [1] 305869 0
Australia
Primary sponsor type
Individual
Name
Stephen Gilbert
Address
C/O Anaesthetic Department
Townsville Hospital
Douglas
Townsville
Queensland 4814
Country
Australia
Secondary sponsor category [1] 306466 0
None
Name [1] 306466 0
Address [1] 306466 0
Country [1] 306466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306127 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 306127 0
Ethics committee country [1] 306127 0
Australia
Date submitted for ethics approval [1] 306127 0
28/05/2020
Approval date [1] 306127 0
01/06/2020
Ethics approval number [1] 306127 0
HREC/2020/QTHS/64534 (May ver 2)

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

Contacts
Principal investigator
Name 102806 0
Dr Stephen Gilbert
Address 102806 0
C/O Anaesthatic Department
Townsville Hospital
Angus Smith Drive
Douglas
Queensland 4814
Country 102806 0
Australia
Phone 102806 0
+61744335300
Fax 102806 0
Email 102806 0
[email protected]
Contact person for public queries
Name 102807 0
Stephen Gilbert
Address 102807 0
C/O Anaesthatic Department
Townsville Hospital
Angus Smith Drive
Douglas
Queensland 4814
Country 102807 0
Australia
Phone 102807 0
+61744335300
Fax 102807 0
Email 102807 0
[email protected]
Contact person for scientific queries
Name 102808 0
Stephen Gilbert
Address 102808 0
C/O Anaesthatic Department
Townsville Hospital
Angus Smith Drive
Douglas
Queensland 4814
Country 102808 0
Australia
Phone 102808 0
+61744335300
Fax 102808 0
Email 102808 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?
Knowledge scores.
Confidence scores.
Participant score of adequate undergraduate education.
Statistical analysis of correlation and differences between groups.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Available to anyone who wishes to access it.
Available for what types of analyses?
Available for any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator on Researchgate https://www.researchgate.net/profile/Stephen_Gilbert9


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.