None listed
Conditions
Brief summary
This study will investigate the feasibility and potential efficacy of a text message intervention in addition to usual care, to improve prescription opioid tapering self-efficacy. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid medication tapering. 40 participants who meet the selection criteria will be randomized to receive either an educational video contextualising the intervention, followed by text messages for four weeks in addition to their usual care, or usual care alone. The message library consists of text messages that are intended to increase the recipient’s self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the feasibility of the intervention and a future trial methodology as the primary objective and compare the changes in opioid medication tapering self-efficacy between groups across a 4-week intervention period as the secondary objective to evaluate potential efficacy.
Interventions
Patients with chronic non-cancer pain on long term opioid therapy who are tapering opioids will be randomised to receive either a text message and video intervention in addition to usual care or usual care alone, for 4 weeks.
Participants randomised to the intervention group will initially receive an educational video (about chronic pain and opioid tapering) of approximately 10 minutes to watch that contextualizes the text messages they will be receiving. The video will be followed by text mes
Patients with chronic non-cancer pain on long term opioid therapy who are tapering opioids will be randomised to receive either a text message and video intervention in addition to usual care or usual care alone, for 4 weeks. Participants randomised to the intervention group will initially receive an educational video (about chronic pain and opioid tapering) of approximately 10 minutes to watch that contextualizes the text messages they will be receiving. The video will be followed by text messages sent to their mobile phone for four weeks, twice per day including weekends. Messages will be sent at random times between 9 AM and 5 PM. The library of text messages are intended to increase the recipient’s self-efficacy to taper opioids. The domains covered by the texts include validation, motivation, education and some advice and support on the key domains of pain, withdrawal symptoms, function/quality of life, mood and tapering. All participants in the intervention group will receive the same messages in the same order. Participants will not be expected or required to respond to the SMS system. Participants will be instructed that their responses will not be replied to. Participants in the intervention group will receive all scheduled messages, unless they choose to withdraw from the study. Delivery of the messages (and responses, if any) will be recorded automatically on the text messaging system. If a message was not delivered, a second message will be sent. Participants can also withdraw from receiving the intervention by replying “STOP” to the text messages at any time. The trial coordinator will then contact the participant to ascertain if the participant is fully withdrawing from the study or just from receiving text messages but will continue to complete the follow-up data collections.
Sponsors
Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or older. • Diagnosed with a chronic (> 3 months) pain condition according to the International Classification of Diseases - 11th Revision. • Have been using opioid analgesics at a dose of at least 40 mg/day Oral Morphine Equivalent for at least four weeks (i.e. participants are likely to have developed a certain level of physical tolerance).35 36 • Have been advised by a clinician to taper opioids. • Are voluntarily tapering opioid medications, as indicated by verbalised willingness and consent. • Be currently tapering or will be tapering their opioid medications at the time of enrolment. There is no restriction on how many times patients may have attempted opioid tapering, nor is there any restriction of the period of time participants may have been tapering before entering the study. • Able to understand written and spoken English. • Own a mobile phone that receives SMS. • Able to give written informed consent and comply with study procedures.
Exclusion criteria
• Cognitive impairment or intellectual disability preventing adherence to the study procedure. • Evidence of severe opioid use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Illicit substance use, including illicit opioid use, is not an exclusion criterion, however if it fits a wider pattern of symptoms indicating a severe opioid use disorder it may inform a decision that the participant is ineligible for the study. • History of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, depressive disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or a positive family history (first degree relative) of psychotic disorder or bipolar affective disorder such that participants might be at more than low/negligible risk by participating in the study. • Any other major, poorly controlled medical or mental health comorbidity. • Participation in another clinical trial concurrently, since this will not constitute ‘usual care’ and can interfere with the study primary and secondary objectives by increasing the burden to patients and influencing estimates.
Outcome results
None listed