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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]

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

Condition category

Condition code

Injuries and Accidents

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]

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]

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]

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]

Patient-reported distress: 2-item Concerns about Pain Scale (CAP-2, short version)

Timepoint [1]

Assessed daily for seven days after study enrolment (days 1-7) and again on day 14 (end of the trial).

Secondary outcome [2]

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]

Days 7 and 14 after study enrolment.

Secondary outcome [3]

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]

Secondary outcome [4]

Timepoint [4]

Assessed daily during hospitalisation (day 1 to discharge) and again on Day 14 (end of trial).

Secondary outcome [5]

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]

Assessed daily during hospitalisation (day 1 to discharge) and again on Day 14 (end of trial).

Secondary outcome [6]

Timepoint [6]

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?

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]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Ramsay Hospital Research Foundation

Address [1]

Level 8/154 Pacific Highway St Leonards NSW 2065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/01/2023

Approval date [1]

27/09/2023

Ethics approval number [1]

Summary

Brief summary

Patients who engage with behavioural pain management strategies (e.g., relaxation, thought management) have better pain relief and use less opioids. However, delivering these strategies in hospital settings can be costly and often is not feasible during acute pain service rounds. Emerging research indicates that behavioural pain management education can effectively be delivered using low-cost digital technology. The aim of this study is to test the hypothesis that patients who receive an mHealth intervention (educational video + supportive daily text messages) will utilise lower doses of opioids across the first week of hospitalisation and one week after discharge compared to those who receive the education video only.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Claire Ashton-James

Address

Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065

Country

Australia

Phone

+612 9463 1528

Fax

[email protected]

Contact person for public queries

Name

Claire Ashton-James

Address

Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065

Country

Australia

Phone

+612 9463 1528

Fax

[email protected]

Contact person for scientific queries

Name

Claire Ashton-James

Address

Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065

Country

Australia

Phone

+612 9463 1528

Fax

[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?

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 ([email protected])

What supporting documents are/will be available?

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

Trial Review

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Documents added automatically