Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 5, 2023
Date Accepted: Aug 29, 2023
A Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and PTSD Symptom Management: Recruitment and attrition in a randomized controlled trial
ABSTRACT
Background:
Increasing access to non-pharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can be shaped and calibrated for symptom burden and enhanced accessibility via virtual healthcare and select population characteristics. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely and virtually teaches CIH skills.
Objective:
The purpose of this paper is to describe attrition during the recruitment and onboarding phase of a randomized controlled trial (RCT) assessing the efficacy of the MR intervention on veterans with comorbid chronic pain and PTSD and their partners.
Methods:
Three-hundred and sixty-four veteran-partner dyads were recruited to participate in a mixed-methods multi-site waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (e.g., spouse) who consented but did not begin the program.
Results:
At the point of completing onboarding, and being randomized to the two treatment arms, of the 364 recruited dyads, 97 dyads (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (8.2%), difficulties with using remote data collection methods and interventions (30.9%), and adverse health experiences unrelated to study activities (17.5%). Enrolled veterans presented at baseline with significant PTSD symptom burden, moderate-to-severe pain severity, and represented a geographically and demographically diverse population.
Conclusions:
Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post COVID-19 climate. Clinical Trial: Clinical Trial # NCT03593772
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.