Development of the Building Efficacy for Successful Tapering (BEST) Program

Goalistics, Llc, Tempe AZ

Investigators

Abstract

ABSTRACT Over 100 million Americans suffer from chronic pain. The use of chronic opioid therapy (COT) for pain has increased dramatically, as have reports of opioid misuse, abuse, dangerous interactions with other drugs, overdose, and death. As concerns over the alarming effects of COT have risen, regulatory efforts have increased as well, including medically supervised opioid tapering. Tapering can be daunting to many patients who lack the self-efficacy and pain management skills to successfully navigate the process. According to Bandura, self-efficacy refers to the belief that one can successfully perform the necessary actions to achieve a desired outcome in a given situation (e.g., tapering). The proposed Phase I SBIR project will include the preliminary development and pilot testing of the online Building Efficacy for Successful Tapering (BEST) program. The BEST Program is a practical application of pain self-management principles specifically targeting the tapering process. BEST is designed to enhance self-efficacy for tapering by training the patient to systematically sample and test a variety of evidence-based non-opioid pain management strategies in order to develop a repertoire of personally vetted techniques. Patients will learn evidence-based strategies (?pain reducers?) derived from cognitive-behavioral, motivational, and interpersonal models of pain self-management, including emotion-focused, behavioral, cognitive, and attentional techniques. Program participants will identify and systematically test and track their custom list of ?pain reducers? from these categories. A reporting function will help patients to visualize progress, gain insight into their most beneficial strategies, and build performance-based self-efficacy. Moreover, as the patient enters data into the BEST program, over time the system will be capable of using those data to offer custom recommendations. If found effective, the BEST Program will fill a significant gap in chronic pain treatment by helping patients to confidently transition from the use of opioids, avoid the pitfalls of misuse/abuse, and heighten the acceptability of alternative treatments. The Phase I project will include 1) content development, 2) web design and software development, 3) formative evaluation/usability testing and revision (N=10 patients undergoing medically supervised opioid tapering), and 4) a pilot randomized controlled trial (N=60 patients undergoing opioid tapering randomly assigned to the BEST Program or to Usual Care). The RCT will provide 1) preliminary estimates of effect sizes for program-related changes in pain self-efficacy, intensity, interference, and self-report of opioid misuse, and 2) evidence of program acceptability. Successful results would lay the groundwork for Phase II, which would involve the addition of several Program enhancements, including a mobile version, a clinician portal to monitor patient progress, and additional tracking features. A full scale RCT would be conducted in Phase II to examine efficacy for a broader range of outcomes in a large sample over an extended follow-up period.