Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial.

BACKGROUND: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old. METHODS: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months. DISCUSSION: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.

"I really had somebody in my corner." Patient experiences with a pharmacist-led opioid tapering program.

BACKGROUND: Opioid tapering has been identified as an effective strategy to prevent the dangers associated with long-term opioid therapy for patients with chronic pain. However, many patients are resistant to tapering, and conversations about tapering can be challenging for health care providers. Pharmacists can play a role in supporting both providers and patients with the process of opioid tapering. OBJECTIVE: Qualitatively describe patient experiences with a unique phone-based and pharmacy-led opioid tapering program implemented within an integrated health care system. METHODS: In-depth telephone interviews with patients who completed the program were recorded, transcribed, and analyzed. Themes were identified through a constant comparative approach. RESULTS: We completed 25 interviews; 80% of patients were women (20), with a mean age of 58 years, and 72% (18) had been using opioids for pain management for 10 or more years. Most (60%) described a positive and satisfying experience with the tapering program. Strengths of the program reported by patients included a patient-centered and compassionate taper approach, flexible taper pace, easy access to knowledgeable pharmacist advocates, and resultant improvements in quality of life (e.g., increased energy). Challenges reported included: unhelpful or difficult-to-access nonpharmacological pain management options, negative quality of life impacts (e.g., inability to exercise), and lack of choice in the taper process. At the end of tapering, most patients (72%) described their pain as reduced or manageable rather than worse and expressed willingness to use the program in the future if a need should arise. CONCLUSIONS: Patients in a pharmacist-led opioid tapering program appreciated the program's individualized approach to care and access to pharmacist' expertise. Most interviewed patients successfully reduced their opioid use and recommended that the program should continue as an offered service. To improve the program, patients suggested increased personalization of the taper process and additional support for withdrawal symptoms and nonpharmacological pain management.

"We Need to Taper." Interviews with Clinicians and Pharmacists About Use of a Pharmacy-Led Opioid Tapering Program.

OBJECTIVE: To identify factors that influence or interfere with referrals by primary care providers (PCPs) to a pharmacist-led telephone-based program to assist patients undergoing opioid tapering. The Support Team Onsite Resource for Management of Pain (STORM) program provides individualized patient care and supports PCPs in managing opioid tapers. DESIGN: Qualitative interviews were conducted with referring PCPs and STORM staff. Interview guides addressed concepts from the RE-AIM framework, focusing on issues affecting referral to the STORM program. SETTING: An integrated healthcare system (HCS) in the Northwest United States. SUBJECTS: Thirty-five interviews were conducted with 20 PCPs and 15 STORM staff. METHODS: Constant comparative analysis was used to identify key themes from interviews. A codebook was developed based on interview data and a qualitative software program was used for coding, iterative review, and content analysis. Representative quotes illustrate identified themes. RESULTS: Use of the STORM opioid tapering program was influenced by PCP, patient, and HCS considerations. Factors motivating use of STORM included lack of PCP time to support chronic pain patients requiring opioid tapering and the perception that STORM is a valued partner in patient care. Impediments to referral included PCP confidence in managing opioid tapering, patient resistance to tapering, forgetting about program availability, and PCP resistance to evolving guidelines regarding opioid tapering goals. CONCLUSIONS: PCPs recognized that STORM supported patient safety and reduced clinician burden. Utilization of the program could be improved through ongoing PCP education about the service and consistent co-location of STORM pharmacists within primary care clinics.

Taking opioids in times of crisis: Institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S.

BACKGROUND: Opioid treatment for chronic pain has garnered heightened public attention and political pressure to control a devastating public health crisis in the United States (U.S.). Resulting policy changes, together with ongoing public and political attention, have pushed health care systems and providers to lower doses or deprescribe and taper patients off opioids. However, little attention has been paid to the impact of such practice changes on patients who had relied on opioid treatment to manage their chronic pain. The aim of this article is to explore experiences with opioid-related care under aggressive tapering efforts and concomitant heightened monitoring and institutional oversight among patients with chronic pain in an integrated delivery system through in-depth interviews. METHODS: We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study. These patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers. We followed the framework method for coding and analysing transcripts using NVivo 12. RESULTS: The experiences of these patients during this period of change can be understood through three interconnected themes: (1) many patients taking opioids experience debilitating physical side effects; (2) navigating opioid treatment contributes to significant emotional distress among many patients with chronic pain and; (3) the quality of patients' relationship with their primary care provider can be negatively affected by negotiations regarding long-term opioid treatment for chronic pain. CONCLUSION: We highlight the importance of utilizing communication approaches that are patient-centered and include shared decision making during the tapering and/or deprescribing processes of opioids and ensuring alternative pain treatments are available to patients with chronic pain.

Whole Systems Within Whole Systems: The Oregon Health Plan's Expansion of Services for Back and Neck Pain.

OBJECTIVES: The authors employ a Whole Systems framework to explore implementation of new guidelines for back and neck pain in Oregon's Medicaid system. Whole Systems research is useful for understanding the relationship between complementary and integrative health care (CIH) and conventional health care systems in real-world clinical and practice settings. DESIGN: Preliminary results are from an observational study designed to evaluate state-wide implementation of CIH and other non-pharmacological treatments for neck and back pain among Oregon Medicaid patients. This natural experiment, even in early stages, provides insight into the challenges of integrating Whole Systems oriented therapies into Medicaid billing and treatment. METHODS: Qualitative data are drawn from: (1) semi-structured interviews with representatives of each of the 16 coordinated care organizations (CCOs) responsible for administering the Oregon's Medicaid insurance through the Oregon Health Plan (OHP); and (2) open-ended survey responses from acupuncturists in all 16 CCO areas. RESULTS: Implementation of the new policy guidelines poses logistical and epistemological challenges. Differences in worldview, inadequate reimbursement, and simple lack of awareness of CIH among medical providers are some of the factors that pose barriers to merging CIH therapies into conventional frameworks. CONCLUSIONS: In this article, we explore the potential for a Whole Systems perspective to better explain the complexity of integrating CIH and other non-pharmacological services into a state financed health care system. Oregon's expansion of services for back and neck pain presents an opportunity to explore challenges and successes in melding multiple approaches to health and pain management into a managed system such as the OHP.

Provider and patient perspectives on opioids and alternative treatments for managing chronic pain: a qualitative study.

BACKGROUND: Current literature describes the limits and pitfalls of using opioid pharmacotherapy for chronic pain and the importance of identifying alternatives. The objective of this study was to identify the practical issues patients and providers face when accessing alternatives to opioids, and how multiple parties view these issues. METHODS: Qualitative data were gathered to evaluate the outcomes of acupuncture and chiropractic (A/C) services for chronic musculoskeletal pain (CMP) using structured interview guides among patients with CMP (n = 90) and primary care providers (PCPs) (n = 25) purposively sampled from a managed care health care system as well as from contracted community A/C providers (n = 14). Focus groups and interviews were conducted patients with CMP with varying histories of A/C use. Plan PCPs and contracted A/C providers took part in individual interviews. All participants were asked about their experiences managing chronic pain and experience with and/or attitudes about A/C treatment. Audio recordings were transcribed and thematically coded. A summarized version of the focus group/interview guides is included in the Additional file 1. RESULTS: We identified four themes around opioid use: (1) attitudes toward use of opioids to manage chronic pain; (2) the limited alternative options for chronic pain management; (3) the potential of A/C care as a tool to help manage pain; and (4) the complex system around chronic pain management. Despite widespread dissatisfaction with opioid medications for pain management, many practical barriers challenged access to other options. Most of the participants' perceived A/C care as helpful for short term pain relief. We identified that problems with timing, expectations, and plan coverage limited A/C care potential for pain relief treatment. CONCLUSIONS: These results suggest that education about realistic expectations for chronic pain management and therapy options, as well as making A/C care more easily accessible, might lead to more satisfaction for patients and providers, and provide important input to policy makers. TRIAL REGISTRATION: ClinicalTrials.gov NCT01345409 , date of registration 28/4/2011.

Primary care physicians, acupuncture and chiropractic clinicians, and chronic pain patients: a qualitative analysis of communication and care coordination patterns.

BACKGROUND: A variety of people, with multiple perspectives, make up the system comprising chronic musculoskeletal pain (CMP) treatment. While there are frequently problems in communication and coordination of care within conventional health systems, more opportunities for communicative disruptions seem possible when providers use different explanatory models and are not within the same health management system. We sought to describe the communication system surrounding the management of chronic pain from the perspectives of allopathic providers, acupuncture and chiropractor (A/C) providers, and CMP patients. METHODS: We collected qualitative data from CMP patients (n = 90) and primary care physicians (PCPs) (n = 25) in a managed care system, and community acupuncture and chiropractic care providers (n = 14) who received high levels of referrals from the system, in the context of a longitudinal study of CMP patients' experience. RESULTS: Multiple points of divergence and communicative barriers were identified among the main stakeholders in the system. Those that were most frequently mentioned included issues surrounding the referral process (requesting, approving) and lack of consistent information flow back to providers that impairs overall management of patient care. We found that because of these problems, CMP patients were frequently tasked and sometimes overwhelmed with integrating and coordinating their own care, with little help from the system. CONCLUSIONS: Patients, PCPs, and A/C providers desire more communication; thus systems need to be created to facilitate more open communication which could positively benefit patient outcomes.

Adherence to, and Satisfaction with, the Self-Acupressure Intervention in the LIFE Weight-Loss Maintenance Study.

BACKGROUND: The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratory post hoc tests suggested that, among participants with highest initial weight-loss, those in the TAT condition regained less weight than those in the SS condition. OBJECTIVE: The aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial. DESIGN: This was a secondary analysis of adherence and satisfaction patterns in a large randomized controlled trial. SETTING: The study was conducted at a prominent health maintenance organization in the Pacific Northwest. SUBJECTS: This study involved 142 obese participants who had lost >10 pounds in a conventional weight-loss program and who were randomized to the experimental acupressure intervention. INTERVENTIONS: The experimental intervention (n=142) arm consisted of instruction and application of a self-acupressure intervention, the Tapas Acupressure Technique® (TAT®). OUTCOME MEASURES: The outcome sought was self-reported satisfaction and frequency of TAT practice. RESULTS: Sixty-six percent of TAT participants attended at least 6 of 8 intervention sessions. More than 80% of participants reported practicing TAT at home, on average, at least 2 days per week. Sixty two percent reported practicing <10 minutes per session, while 27% reported practicing 10-20 minutes per session. Higher satisfaction scores were significantly correlated with less weight regain (p=0.001). Frequency of TAT practice was not significantly associated with changes in weight, stress, insomnia, depression, or quality of life. CONCLUSIONS: These data suggest moderate acceptance of, and adherence to, the TAT intervention. Further research is required to identify and achieve optimal home-practice levels of self-acupressure techniques.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance.

BACKGROUND: Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. METHODS: Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. RESULTS: Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. CONCLUSIONS: The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.

Acupuncture and chiropractic care for chronic pain in an integrated health plan: a mixed methods study.

BACKGROUND: Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community. METHODS/DESIGN: This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data. DISCUSSION: Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01345409.

Use of complementary and alternative medicine for temporomandibular disorders.

AIMS: Despite many reports about complementary and alternative medicine (CAM) use in the general population, little information exists about specific CAM therapies used for particular health conditions. This study examines the use of CAM therapies among patients with temporomandibular disorders (TMD). METHODS: We surveyed 192 patients with documented TMD as part of a larger project on the effectiveness of various CAM modalities for TMD patients. The survey asked about use of and attitudes toward specific CAM therapies for treating TMD and other patient-identified health conditions. The survey also measured physical health, health behavior, and psychosocial functioning. RESULTS: Nearly two thirds of the respondents (62.5%; n = 120) reported using CAM therapies for TMD or a related condition. Of all the therapies reported, massage was rated as the most frequent and among the most satisfactory and helpful. In general, respondents who used CAM for their TMD reported being most satisfied with the "hands on" CAM therapies (massage, acupuncture, and chiropractic care). The vast majority of respondents reported using CAM approaches for TMD simultaneously with conventional care (95.6%; 66 of 69). Those using CAM for TMD tended to be older, had a history of multiple medical problems, and reported more positive psychologic functioning. Respondents who most often reported CAM treatment as "very helpful" for their TMD were likely to be healthier (i.e., reporting higher levels of exercise and fewer sleep disturbances). CONCLUSION: Given the frequent use of CAM treatments by our respondents, allopathic providers should inquire about the adjunctive use of CAM among their TMD patients.