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Trial registered on ANZCTR


Registration number
ACTRN12623000006640
Ethics application status
Approved
Date submitted
9/12/2022
Date registered
9/01/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a digital pain management intervention on pain and reliance on opioids in patients with rib fractures
Scientific title
Evaluating the efficacy of a digital behavioural pain management intervention to improve analgesia and reduce reliance on opioids in adult patients with rib fractures
Secondary ID [1] 308584 0
Nil known
Universal Trial Number (UTN)
U1111-1285-8639
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 328597 0
Condition category
Condition code
Injuries and Accidents 325610 325610 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Digital behavioural pain management
- Delivered entirely via one-way SMS (text messaging)
- Patients will initially be sent an SMS with a link to an online video resource containing brief, evidence based, behavioural pain management education (BPME). The video will be approximately 10 minutes in duration and will include narrated, animated PowerPoint slides with information on behavioural pain management strategies (e.g., relaxation techniques and distraction) as well as education about rib fractures (e.g., timeline of recovery). Patients will then receive two SMS per day (mid-morning and mid-afternoon) for 14 consecutive days (encompassing up to a week of hospitalisation and one-week post-discharge). Text messages serve to remind patients about the information provided in the behavioural pain management educational video (e.g., “If you inhale deeply, your lungs will stay healthy and reduce your chance of an infection”) and reassure patients that pain after rib fractures is normal (“Rib fractures are surprisingly common and can really hurt. Hang in there though! It will hurt less and less every day as your body heals”).
- Intervention will be co-designed with patients who have recently been in hospital with rib fractures and clinicians experienced in managing rib fractures. Patients and clinicians will be presented with the online video resource and example text messages and invited to provide feedback on appropriateness and usefulness/helpfulness. The content of the video and text messages will be adjusted in response to the feedback.
- Intervention will be received in addition to usual care. Usual care in this context is multidisciplinary with a focus on maximising non-opioid analgesia while encouraging pulmonary hygiene. It may include incentive spirometry, high flow nasal prong oxygen, and/or multimodal analgesia (including patient-controlled analgesia).
- Engagement with the video will be assessed using a study-specific questionnaire shortly after participants receive the link to the video. Participants will asked to confirm they have watched the video by answering two questions about the content of the video.
- Engagement with the text messages will be assessed using a using a study-specific questionnaire at the end of the study. Participants in the intervention group will be asked whether or not they read the text messages they were sent during the study.
Intervention code [1] 325033 0
Treatment: Other
Comparator / control treatment
Education video only
- Patients will receive an SMS with a link to the same BPME video delivered to patients in the intervention group. The active control group will not receive additional supportive text messages. However, they will receive text messages containing links to brief online surveys containing study outcome measures.
- Intervention will be received in addition to usual care. Usual care in this context is multidisciplinary with a focus on maximising non-opioid analgesia while encouraging pulmonary hygiene. It may include incentive spirometry, high flow nasal prong oxygen, and/or multimodal analgesia (including patient-controlled analgesia).
Control group
Active

Outcomes
Primary outcome [1] 333337 0
Patient-reported pain intensity on respiration: Patients will be asked to indicate their pain on “best attempt at a deep breath” using an 11-point numerical rating scale (0=no pain, 10 = worst pain imaginable).
Timepoint [1] 333337 0
Assessed daily for seven days after study enrolment (days 1-7) and again on day 14 (end of the trial). Day 7 will be the primary endpoint.
Secondary outcome [1] 416673 0
Patient-reported distress: 2-item Concerns about Pain Scale (CAP-2, short version)
Timepoint [1] 416673 0
Assessed daily for seven days after study enrolment (days 1-7) and again on day 14 (end of the trial).
Secondary outcome [2] 416674 0
Self-reported adherence to behavioural pain management strategies: Assessed on Day 7 and 14 using a single self-report item (6-point Likert scale): “How often are you using the strategies you learned in the video that you watched when you enrolled in the study to help you to manage your pain?” (1 = Not at all, 2 = A couple of times in the week, 3 = Every couple of days, 4 = Once a day, 5 = A couple of times a day, 6 = Several times a day).
Timepoint [2] 416674 0
Days 7 and 14 after study enrolment.
Secondary outcome [3] 428271 0
Opioid use: Assessed daily during hospitalisation (extracted from health records) and again on Day 14 (self-reported use over past 72 hours). Opioids used will be converted to an oral morphine equivalent daily dose using the ANZCA opioid converter (http://www.opioidcalculator.com.au). Opioids prescribed at discharge will be retrieved from medical records.
Timepoint [3] 428271 0
Secondary outcome [4] 428272 0
Opioid use: Assessed daily during hospitalisation (extracted from health records) and again on Day 14 (self-reported use over past 72 hours). Opioids used will be converted to an oral morphine equivalent daily dose using the ANZCA opioid converter (http://www.opioidcalculator.com.au). Opioids prescribed at discharge will be retrieved from medical records.
Timepoint [4] 428272 0
Assessed daily during hospitalisation (day 1 to discharge) and again on Day 14 (end of trial).
Secondary outcome [5] 428273 0
Acceptability of intervention components: Assessed using a survey at the end of the study period. The survey design was based on previous studies conducted by our research team and contains Likert scales and open-ended questions about the usefulness, readability, and acceptability of the digital support
Timepoint [5] 428273 0
Assessed daily during hospitalisation (day 1 to discharge) and again on Day 14 (end of trial).
Secondary outcome [6] 428274 0
Acceptability of intervention components: Assessed using a survey at the end of the study period. The survey design was based on previous studies conducted by our research team and contains Likert scales and open-ended questions about the usefulness, readability, and acceptability of the digital support
Timepoint [6] 428274 0
Day 15 after study enrolment

Eligibility
Key inclusion criteria
- Age 18 years or older
- With isolated rib fracture/s
- Within one day of hospital admission
- Able to understand written and spoken English.
- Owns a mobile phone that receives text messages
- Able to give written informed consent and comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to complete study procedures (lack of fluency in English, cognitive ability, mental health status, medical status)
- Admission to hospital with other injuries or comorbidities (e.g., head, extremity, lung, or abdominal trauma)
- NSAIDs contraindicated
- Regional anaesthesia or blockade likely to be used for pain management

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation completed by central randomisation software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To address the study hypotheses, a marginal mixed model analysis will be used, evaluating the main effect of the group (intervention vs. active control). A linear mixed model will be used to test for a difference between outcome trends recorded over the 14-day trial. All analyses will be conducted using SAS software (v 9.4), and a per-protocol and intent-to-treat analyses (all randomised participants will be included in the analyses) will both be conducted, to minimise bias secondary to missing data or dropouts. Where applicable, results will be reported with 95% confidence intervals, with an alpha of 0.05 used to establish statistical significance.

The study was powered to test for mean differences in pain intensity on respiration (primary outcome). We set a power threshold of 0.8, a two-tailed alpha of 0.05, standard deviation (SD) of pain at 2.5, and SD ratio at 1.5 over 7 days. Accordingly, we estimate the need for 51 patients per group to detect a 1.3 (out of 10) difference, in overall, in pain intensity. This is the minimum clinically important difference (MCID) for average pain levels (4 to 7 out of 10) in acute pain. With 15% estimated dropouts, we will recruit 120 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
15/07/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25764 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 25782 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 39133 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 312834 0
Charities/Societies/Foundations
Name [1] 312834 0
Ramsay Hospital Research Foundation
Country [1] 312834 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 314475 0
None
Name [1] 314475 0
Address [1] 314475 0
Country [1] 314475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312112 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312112 0
Ethics committee country [1] 312112 0
Australia
Date submitted for ethics approval [1] 312112 0
30/01/2023
Approval date [1] 312112 0
27/09/2023
Ethics approval number [1] 312112 0

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

Contacts
Principal investigator
Name 123518 0
A/Prof Claire Ashton-James
Address 123518 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 123518 0
Australia
Phone 123518 0
+612 9463 1528
Fax 123518 0
Email 123518 0
claire.ashton-james@sydney.edu.au
Contact person for public queries
Name 123519 0
Claire Ashton-James
Address 123519 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 123519 0
Australia
Phone 123519 0
+612 9463 1528
Fax 123519 0
Email 123519 0
claire.ashton-james@sydney.edu.au
Contact person for scientific queries
Name 123520 0
Claire Ashton-James
Address 123520 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 123520 0
Australia
Phone 123520 0
+612 9463 1528
Fax 123520 0
Email 123520 0
claire.ashton-james@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By emailing A/Prof Claire Ashton-James (claire.ashton-james@sydney.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17817Study protocol    By emailing A/Prof Claire Ashton-James (claire.ash... [More Details]
17818Statistical analysis plan    By emailing A/Prof Claire Ashton-James (claire.ash... [More Details]
17819Informed consent form    By emailing A/Prof Claire Ashton-James (claire.ash... [More Details]
17820Ethical approval    By emailing A/Prof Claire Ashton-James (claire.ash... [More Details]



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.