Background & Aims
Pain self-management skills training and psychosocial support may help people to reduce their opioid dose without increasing pain and interference. To improve access to these items, we co-designed a digital (video and mobile text messaging) intervention to provide such information and support.[1] We demonstrated the feasibility, acceptability, and potential efficacy of this intervention in a pilot study, [2] but recruitment was slow: despite being open in three busy metropolitan hospital-based multidisciplinary pain centers in Australia, total recruitment averaged just 2 per month, making it unworkable for a larger, adequately powered study without opening many more sites. To improve the efficiency of recruitment, we decided to try online recruitment of people from the community via social media. Here we report our experiences using this novel recruitment method.
Methods
Recruitment to the pilot study (traditional approach):[3] busy clinicians – who were not investigators and with little or no interest in the study – were expected to identify people on their clinic lists who had been on long-term opioid therapy (LTOT), defined as at least 40 mg oral morphine equivalents daily for at least 4 weeks; introduce the study to them; and solicit their interest in participating. Patients who were interested stayed behind after their appointment to complete the consent process with a research nurse.
Recruitment to larger study (via social media):[4] the study is advertised on Facebook (costs $A100/day), seeking people who are on LTOT and interested to reduce their dose. Enrolment is all on line: a QR code in the advertisement provides the person with a link to a REDCap webpage where they complete a screening questionnaire and then an eligibility questionnaire. Eligible people are directed to a consent form prior to randomization.
Results
Pilot study: Twenty-eight participants were randomized in 14 months, of whom 26 completed the study and 2 were lost to follow-up. Larger study (randomization target is 74): During the first 10 months of Facebook advertising, we have received over 900 applications to participate, from whom 320 were eligible, 87 provided consent, 55 (75% of target) have been randomised. Forty-six have received the allocated intervention while 12 withdrew their consent after randomisation. Compared with the pilot trial, participants in the larger trial are older, more likely to live in rural or regional areas, less likely to have a history of previous tapering, but more likely to drop out of the study.
Conclusions
Recruitment via social media has had several advantages: recruitment almost 3 times faster; reduced governance burden required for multiple sites; favorable cost-effectiveness, with per annum cost of advertising $A36,500 vs. research nurse salary $A 125,000. Potential problems may include: 1. Efficacy. Will the differences between the study populations in important socio-demographic and clinical characteristics may affect response to the intervention? 2. Blinding/masking. We used an active control and limited disclosure to mask the interventions. This may have resulted in participants applying to the study with different expectations, increasing likelihood of drop-out after they are provided with the details of the allocated intervention. This may create bias in estimating the true effect size. 3. Privacy and other ethical issues. Social media platforms may be challenged by privacy and confidentiality.[5] Strategies for combating robots and other fraudulent participation are needed.
References
1.Magee MR, Gholamrezaei A, McNeilage AG, Sim A, Dwyer L, Ferreira ML, Darnall BD, Glare P, Ashton-James CE A Digital Video and Text Messaging Intervention to Support People With Chronic Pain During Opioid Tapering: Content Development Using Co-design. JMIR Form Res. 2022 Nov 10;6(11):e40507. doi: 10.2196/40507
2.Gholamrezaei A, Magee MR, McNeilage AG, et al. A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial. medRxiv [Preprint]. doi: 10.1101/2023.05.10.23289771.
3.Magee M, Gholamrezaei A, McNeilage AG, Dwyer L, Sim A, Ferreira M, Darnall B, Glare P, Ashton-James C Evaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: protocol for a pilot randomised, single-blind, controlled trial.
.BMJ Open. 2022 Apr 26;12(4):e057174. doi: 10.1136/bmjopen-2021-057174.
4.Gholamrezaei A, Magee MR, McNeilage AG, et al. Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial. BMJ Open. 2023;13:e073297.
5.Darko EM, Kleib M, Olson J. Social Media Use for Research Participant Recruitment: Integrative Literature Review. J Med Internet Res 2022; 24(8): e38015
Presenting Author
Paul Glare
Poster Authors
Paul Glare
MD
University of Sydney
Lead Author
Topics
- Trial Design