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Trial registered on ANZCTR


Registration number
ACTRN12624000176561
Ethics application status
Approved
Date submitted
10/01/2024
Date registered
23/02/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Opioid Safety Toolkit
Scientific title
Evaluation of an Opioid Safety Toolkit: A randomised controlled trial comparing the effect of an co-designed opioid safety toolkit to an existing website on opioid safety behaviours in people who are prescribed opioids
Secondary ID [1] 311118 0
None
Universal Trial Number (UTN)
Trial acronym
Prescription Opioid Safety Toolkit (POST)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 332274 0
Preventative health 332275 0
Condition category
Condition code
Public Health 328987 328987 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition is exposure to the online Prescription Opioid Safety Toolkit that has been co-designed for this trial. The Prescription Opioid Safety Toolkit will include interactive self-completed opioid outcome tools, videos and other information designed for consumers on safer opioid use, including information on naloxone. Participants randomised to the intervention arm will be emailed a link to the Toolkit and asked to engage with the online resource initially for 30-60 minutes before completing a brief (10 min) follow up survey at Time 1, and a further 20-min follow up survey 4 weeks later at Time 2. Participants will be advised that they may choose to spend longer on the website initially and can or return to the online materials at a later time.
To monitor adherence, participants will be asked at Time 1 how long they initially spent viewing the online material, as well as confirming that the Toolkit has been accessed via the link provided and which elements of the Toolkit are accessed and/or completed.
Intervention code [1] 327565 0
Behaviour
Comparator / control treatment
The control condition is an existing website with information on prescribed opioids (https://www.nps.org.au/consumers/opioid-medicines). Participants randomised to the control arm will be emailed a link to this existing consumer website on opioids and asked to engage with the online resource initially for 30-60 minutes before completing a brief follow up survey at Time 1, and a further follow up survey 4 weeks later at Time 2. Participants in the control arm will also be advised that they may choose to spend longer on the website initially and can or return to the online materials at a later time.
Participants will be asked at Time 1 how long they initially spent viewing the online material.
Control group
Active

Outcomes
Primary outcome [1] 336781 0
Naloxone access intentions
Timepoint [1] 336781 0
Measured at baseline, T1 (immediately after the intervention [Primary timepoint]) and T2 (four weeks after the intervention).
Primary outcome [2] 336782 0
Naloxone requested
Timepoint [2] 336782 0
Measured at Baseline and at Time 2 (T2, follow-up survey conducted four weeks after the intervention [Primary Timepoint]).
Primary outcome [3] 336783 0
Seeking information to support opioid safety from a healthcare provider
Timepoint [3] 336783 0
Follow-up interview at Time 2 (four weeks after the intervention).
Secondary outcome [1] 429668 0
Naloxone and overdose knowledge immediately after the intervention
Timepoint [1] 429668 0
Measured at Baseline, T1 (immediately after the intervention) and T2 (four weeks after the intervention).
Secondary outcome [2] 430424 0
Opioid Risk Behaviours
Timepoint [2] 430424 0
Measured at Baseline and T2 (four weeks after the intervention), assessed with linear mixed models using all timepoints.
Secondary outcome [3] 430425 0
Level of opioid related risk
Timepoint [3] 430425 0
Measured at Baseline, T1 (immediately after the intervention) and T2 (four weeks after the intervention), assessed with linear mixed models using all timepoints.
Secondary outcome [4] 430426 0
Time spent reviewing the online resource
Timepoint [4] 430426 0
T1 (immediately after the intervention)
Secondary outcome [5] 430427 0
User satisfaction with the online resource
Timepoint [5] 430427 0
T1 (immediately after the intervention)
Secondary outcome [6] 430497 0
Naloxone access
Timepoint [6] 430497 0
Measured at Baseline and T2 (four weeks after the intervention), assessed with linear mixed models using all timepoints.
Secondary outcome [7] 430499 0
Change in naloxone and overdose knowledge over time
Timepoint [7] 430499 0
Measured at Baseline T1 (immediately after the intervention) and T2 (four weeks after the intervention), assessed with linear mixed models using all timepoints.

Eligibility
Key inclusion criteria
Eligible participants will be Australian adults aged at least 18 who have been prescribed opioids for non-cancer pain for at least two weeks, and have taken opioids in the past four weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide voluntary informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation through REDcap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation in a 1:1 ratio using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined based on a test of difference between two independent proportions, with an estimated 20% of people in the intervention group meeting the criteria for the primary outcomes, compared to 5% of the control condition. A sample size of 202 participants (101 per group) was determined to provide 90% power with a a of 0.05. To allow for 30% attrition, we will recruit at least 289 people, so that that we have at least 202 people in the evaluable sample. Secondary outcomes assessed at multiple time points will be analysed using linear mixed models with regression analyses appropriate to the variable type. Dichotomous outcomes will be assessed using an test of proportions and an independent t-test will to compare mean time spent reviewing the online resource. We will conduct both intention to treat and per protocol analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2024
Actual
12/06/2024
Date of last participant enrolment
Anticipated
14/06/2024
Actual
22/07/2024
Date of last data collection
Anticipated
14/07/2024
Actual
23/08/2024
Sample size
Target
290
Accrual to date
Final
314
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315375 0
Government body
Name [1] 315375 0
Australian Government-Department of Health and Aged Care
Country [1] 315375 0
Australia
Funding source category [2] 315378 0
Government body
Name [2] 315378 0
National Health and Medical Research Council
Country [2] 315378 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 317436 0
None
Name [1] 317436 0
Address [1] 317436 0
Country [1] 317436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314292 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314292 0
Ethics committee country [1] 314292 0
Australia
Date submitted for ethics approval [1] 314292 0
02/12/2023
Approval date [1] 314292 0
14/12/2023
Ethics approval number [1] 314292 0
40988

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

Contacts
Principal investigator
Name 131086 0
Prof Suzanne Nielsen
Address 131086 0
Monash University Peninsula Campus, Level 2, Building D 47-49 Moorooduc Hwy, Frankston 3199, Victoria Australia
Country 131086 0
Australia
Phone 131086 0
+61 3 9904 4641
Fax 131086 0
Email 131086 0
suzanne.nielsen@monash.edu
Contact person for public queries
Name 131087 0
Suzanne Nielsen
Address 131087 0
Monash University Peninsula Campus, Level 2, Building D 47-49 Moorooduc Hwy, Frankston 3199, Victoria Australia
Country 131087 0
Australia
Phone 131087 0
+61 3 9904 4641
Fax 131087 0
Email 131087 0
suzanne.nielsen@monash.edu
Contact person for scientific queries
Name 131088 0
Suzanne Nielsen
Address 131088 0
Monash University Peninsula Campus, Level 2, Building D 47-49 Moorooduc Hwy, Frankston 3199, Victoria Australia
Country 131088 0
Australia
Phone 131088 0
+61 3 9904 4641
Fax 131088 0
Email 131088 0
suzanne.nielsen@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data will be shared on reasonable request and appropriate ethical approval
When will data be available (start and end dates)?
12 months after publication of the primary outcomes, for five years after publication.
Available to whom?
Approved researchers
Available for what types of analyses?
Analysis outside the scope of the primary trial outcomes
How or where can data be obtained?
By contacting the principle researcher (suzanne.nielsen@monash.edu)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21135Study protocol  Suzanne.nielsen@monash.edu



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.