Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program

BACKGROUND Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic low back pain. However, only half of Department of Veterans Affairs (VA) patients have access to trained CBT therapists, and program expansion is costly. CBT typically consists of 10 weekly hour-long sessions. However, some patients improve after the first few sessions while others need more extensive contact. OBJECTIVE We are applying principles from "reinforcement learning" (a field of artificial intelligence or AI) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each patient's unique and changing needs (AI-CBT). AI-CBT uses feedback from patients about their progress in pain-related functioning measured daily via pedometer step counts to automatically personalize the intensity and type of patient support. The specific aims of the study are to (1) demonstrate that AI-CBT has pain-related outcomes equivalent to standard telephone CBT, (2) document that AI-CBT achieves these outcomes with more efficient use of clinician resources, and (3) demonstrate the intervention's impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, and patients' likelihood of dropout. METHODS In total, 320 patients with chronic low back pain will be recruited from 2 VA healthcare systems and randomized to a standard 10 sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives including: (1) 15-minute contacts with a therapist, and (2) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients' personally tailored treatment plans based on daily feedback via IVR about their pedometer-measured step counts, CBT skill practice, and physical functioning. Outcomes will be measured at 3 and 6 months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout. Our primary hypothesis is that AI-CBT will result in pain-related functional outcomes that are at least as good as the standard approach, and that by scaling back the intensity of contact that is not associated with additional gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. RESULTS The trial is currently in the start-up phase. Patient enrollment will begin in the fall of 2016 and results of the trial will be available in the winter of 2019. CONCLUSIONS This study will evaluate an intervention that increases patients' access to effective CBT pain management services while allowing health systems to maximize program expansion given constrained resources.