Pre-implementation formative evaluation of cooperative pain education and self-management expanding treatment for real-world access: A pragmatic pain trial.

OBJECTIVE: Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT-CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT-CP from the perspective of CBT-CP clinicians and referring primary care clinicians. METHODS: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician-delivered CBT-CP and remotely delivered, technology-assisted CBT-CP. Analysis was informed by a grounded theory approach. RESULTS: Twenty-six clinicians (CBT-CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT-CP, (3) referring clinician's difficulty identifying suitable candidates for CBT-CP, and (4) preference for interventions that can be completed from home. CONCLUSIONS: This formative evaluation identified clinician and system barriers to widespread implementation of CBT-CP and allowed for refinement of the subsequent implementation of two forms of CBT-CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT-CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real-world settings and may provide important information to guide future system-wide implementation efforts.

A Research Agenda for Advancing Non-pharmacological Management of Chronic Musculoskeletal Pain: Findings from a VHA State-of-the-art Conference.

Chronic pain is widely prevalent among Veterans and can have serious negative consequences for functional status and quality of life among other domains. The Veterans Health Administration (VHA) convened a state-of-the-art (SOTA) conference to develop research priorities for advancing the science and clinical practice of non-pharmacological management of chronic musculoskeletal pain. In this perspective article, we present the methods and consensus recommendations for research priorities emanating from the SOTA. In the months leading up to the SOTA, a core group of researchers defined four areas of focus: psychological/behavioral therapies; exercise/movement therapies; manual therapies; and models for delivering multi-modal pain care and divided into workgroups. Each workgroup, in their respective areas of focus, identified seminal studies capturing the state of the evidence. Herein, we present consensus recommendations ranging from efficacy to effectiveness to implementation/dissemination research depending on the state of the evidence as assessed by participants, including commentary on common elements across workgroups and future areas of innovation in study design, measurement, and outcome ascertainment.

Developing a typology of patient-generated behavioral goals for cognitive behavioral therapy for chronic pain (CBT-CP): classification and predicting outcomes.

Patient-generated treatment goals describe what patients value, yet the content of these goals, and the relationship among goal types, goal accomplishment, and treatment outcomes has received little examination. We used inductive sorting to categorize patient-generated goals made by 147 adults receiving cognitive-behavioral therapy for chronic pain. The resulting goal categories were: Physical Activity (29.0%), Functional Status (24.6%), Wellness (16.3%), Recreational Activities (11.3%), House/Yard Work (9.7%), Socializing (7.1%), and Work/School (2.0%). Next, we examined associations between number of goals by category, goal accomplishment, and clinically meaningful improvements in pain-related interference, pain intensity and depressive symptoms. Improvement in all outcome domains was related to goal accomplishment. Additionally, depressive symptoms were related to number of Physical Activity, House/Yard Work, Recreational Activities, and Wellness goals, whereas improved pain-intensity was significantly related to House/Yard Work. Classifying patient-generated goals facilitates investigation of the relationships among goal type, goal accomplishment and treatment outcomes.

Barriers and facilitators to use of non-pharmacological treatments in chronic pain.

BACKGROUND: Consensus guidelines recommend multi-modal chronic pain treatment with increased uptake of non-pharmacological pain treatment modalities (NPMs). We aimed to identify the barriers and facilitators to uptake of evidence-based NPMs from the perspectives of patients, nurses and primary care providers (PCPs). METHODS: We convened eight separate groups and engaged each in a Nominal Group Technique (NGT) in which participants: (1) created an individual list of barriers (and, in a subsequent round, facilitators) to uptake of NPMs; (2) compiled a group list from the individual lists; and (3) anonymously voted on the top three most important barriers and facilitators. In a separate process, research staff reviewed each group's responses and categorized them based on staff consensus. RESULTS: Overall, 26 patients (14 women) with chronic pain participated; their mean age was 55. Overall, 14 nurses and 12 PCPs participated. Seven healthcare professionals were men and 19 were women; the mean age was 45. We categorized barriers and facilitators as related to access, patient-provider interaction, treatment beliefs and support. Top-ranked patient-reported barriers included high cost, transportation problems and low motivation, while top-ranked facilitators included availability of a wider array of NPMs and a team-based approach that included follow-up. Top-ranked provider-reported barriers included inability to promote NPMs once opioid therapy was started and patient skepticism about efficacy of NPMs, while top-ranked facilitators included promotion of a facility-wide treatment philosophy and increased patient knowledge about risks and benefits of NPMs. CONCLUSIONS: In a multi-stakeholder qualitative study using NGT, we found a diverse array of potentially modifiable barriers and facilitators to NPM uptake that may serve as important targets for program development.

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain.

BACKGROUND: The Institute of Medicine report "Relieving Pain in America" recommends the promotion of patient self-management of pain for all people with pain. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidence-based treatments designed to facilitate self-management of chronic pain conditions. Although CBT is efficacious, many patients have limited or no access to CBT. Technology-assisted delivery of CBT may improve access while maintaining efficacy. METHODS/DESIGN: We describe a randomized non-inferiority trial of interactive voice response (IVR)-based CBT for patients with chronic low back pain. This intervention uses daily IVR monitoring and weekly pre-recorded therapist feedback, based on patient-reported information, to provide treatment for patients at home. A total of 230 patients with chronic low back pain are being identified from a single statewide health system serving US military veterans. Participants are randomized to receive either ten weeks of in-person CBT or IVR-based CBT. The primary outcome is pain intensity as measured by the Numeric Rating Scale immediately post-treatment. Secondary outcomes include pain-related interference, emotional functioning, and quality of life measured immediately post treatment, and 6 and 9 months post recruitment. Exploratory objectives of the study are to examine: (1) potential mediators of impact on clinical outcomes (treatment retention, self-reported skill practice ratings, IVR call adherence, and treatment satisfaction); and (2) moderators of treatment engagement, adherence to therapist recommendations for pain coping skill practice, and effects on clinical outcomes. DISCUSSION: This non-inferiority trial may identify an alternative to resource intensive in-person CBT that allows many more patients to receive care while also increasing retention of those enrolled in the program. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01025752 . Registered 3 December 2009.

A partnered approach to opioid management, guideline concordant care and the stepped care model of pain management.

BACKGROUND: Pain is the most common presenting problem in primary care. Opioid therapy (OT) for chronic pain has increased dramatically over the past decade, as have related negative outcomes. Despite the development and dissemination of policy and clinical practice guidelines for pain management and OT, adoption has been variable. The Veterans Health Administration (VHA) has established a Stepped Care Model of Pain Management (SCM-PM) as an evidence-based framework and single standard of pain care to promote guideline-concordant care, but to date its adoption and related outcomes have not been systematically examined. OBJECTIVE: Our aim was to examine changes in care for Veterans receiving long-term OT for management of chronic pain over a four-year study period. DESIGN: As part of a comprehensive implementation evaluation of performance improvements, the current evaluation reports performance improvement outcomes related to pain management and OT over a four-year period. SUBJECTS: We studied Veterans receiving long-term (90+ consecutive days) OT through primary care. INTERVENTIONS: We engaged an interdisciplinary clinical-research team to develop and implement a multifaceted performance improvement approach that included interactive educational strategies and other organizational initiatives. MAIN MEASURES: We measured the proportion of patients receiving long-term OT; use of opioid risk mitigation strategies; referrals to pain-related specialty services; and use of non-opioid analgesics. KEY RESULTS: The proportion of patients receiving high-dose opioids decreased over four years (27.7 % to 24.7 %). The use of opioid risk mitigation strategies increased significantly. Referrals to physical therapy and chiropractic care and prescriptions for topical analgesics increased significantly, while referrals to the pain medicine specialty clinic decreased. CONCLUSIONS: We demonstrate improvements in the management of veterans receiving OT that are consistent with the SCM-PM and published practice guidelines. We highlight how partnerships among funders, researchers, clinicians, and administrators contributed to the project's design and implementation, and to the dissemination strategy and future directions for improving opioid management and pain care.

A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain.

A randomized controlled trial compared cognitive behavioral therapy (CBT) and diabetes education (ED) as an adjunctive treatment for diabetic peripheral neuropathic pain (DPNP). We examined change from baseline to 12- and 36-week follow-up in overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning, among others. Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up. CBT reduced neuropathic pain intensity at 12-weeks more than ED. At 36-weeks, CBT was superior to ED for improving pain interference and mental health functioning. Results provide evidence of benefit of CBT for DPNP.ClinicalTrials.gov Identifier: NCT00830011.

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial.

Importance: Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment. Objectives: To determine if a CBT-CP program that personalizes patient treatment using reinforcement learning, a field of artificial intelligence (AI), and interactive voice response (IVR) calls is noninferior to standard telephone CBT-CP and saves therapist time. Design, Setting, and Participants: This was a randomized noninferiority, comparative effectiveness trial including 278 patients with chronic back pain from the Department of Veterans Affairs health system (recruitment and data collection from July 11, 2017-April 9, 2020). More patients were randomized to the AI-CBT-CP group than to the control (1.4:1) to maximize the system's ability to learn from patient interactions. Interventions: All patients received 10 weeks of CBT-CP. For the AI-CBT-CP group, patient feedback via daily IVR calls was used by the AI engine to make weekly recommendations for either a 45-minute or 15-minute therapist-delivered telephone session or an individualized IVR-delivered therapist message. Patients in the comparison group were offered 10 therapist-delivered telephone CBT-CP sessions (45 minutes/session). Main Outcomes and Measures: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ; range 0-24), measured at 3 months (primary end point) and 6 months. Secondary outcomes included pain intensity and pain interference. Consensus guidelines were used to identify clinically meaningful improvements for responder analyses (eg, a 30% improvement in RMDQ scores and pain intensity). Data analyses were performed from April 2021 to May 2022. Results: The study population included 278 patients (mean [SD] age, 63.9 [12.2] years; 248 [89.2%] men; 225 [81.8%] White individuals). The 3-month mean RMDQ score difference between AI-CBT-CP and standard CBT-CP was -0.72 points (95% CI, -2.06 to 0.62) and the 6-month difference was -1.24 (95% CI, -2.48 to 0); noninferiority criterion were met at both the 3- and 6-month end points (P < .001 for both). A greater proportion of patients receiving AI-CBT-CP had clinically meaningful improvements at 6 months as indicated by RMDQ (37% vs 19%; P = .01) and pain intensity scores (29% vs 17%; P = .03). There were no significant differences in secondary outcomes. Pain therapy using AI-CBT-CP required less than half of the therapist time as standard CBT-CP. Conclusions and Relevance: The findings of this randomized comparative effectiveness trial indicated that AI-CBT-CP was noninferior to therapist-delivered telephone CBT-CP and required substantially less therapist time. Interventions like AI-CBT-CP could allow many more patients to be served effectively by CBT-CP programs using the same number of therapists. Trial Registration: ClinicalTrials.gov Identifier: NCT02464449.

Predictors of engagement in an internet-based cognitive behavioral therapy program for veterans with chronic low back pain.

Internet-based interventions for chronic pain have demonstrated efficacy and may address access barriers to care. Participant characteristics have been shown to affect engagement with these programs; however, limited information is available about the relationship between participant characteristics and engagement with internet-based programs for self-management of chronic pain. The current study examined relationships between demographic and clinical characteristics and engagement with the Pain EASE program, a self-directed, internet-based cognitive behavioral therapy intervention for veterans with chronic low back pain (cLBP). Veterans with cLBP were enrolled in a 10 week trial of the Pain EASE program. Engagement measures included the number of logins, access to coping skill modules, and completed study staff-initiated weekly check-in calls. Regression analyses were conducted to identify significant predictors of engagement from hypothesized predictors (e.g., race/ethnicity, age, depressive symptom severity, and pain interference). Participants (N = 58) were 93% male, 60.3% identified as White, and had a mean age of 54.5 years. Participants logged into the program a median of 3.5 times, accessed a median of 2 skill modules, and attended a median of 6 check-in calls. Quantile regression revealed that, at the 50th percentile, non-White-identified participants accessed fewer modules than White-identified participants (p = .019). Increased age was associated with increased module use (p = .001). No clinical characteristics were significantly associated with engagement measures. White-identified race/ethnicity and increased age were associated with greater engagement with the Pain EASE program. Results highlight the importance of defining and increasing engagement in internet-delivered pain care.

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.