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.

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial.

BACKGROUND: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy. OBJECTIVE: To determine the effectiveness of a group-based CBT intervention for chronic pain. DESIGN: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592). SETTING: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest. PARTICIPANTS: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy. INTERVENTION: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care. MEASUREMENTS: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes. RESULTS: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups. LIMITATION: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear. CONCLUSION: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication. PRIMARY FUNDING SOURCE: National Institutes of Health.

A Pilot Study to Adapt a Trauma-Informed, Mindfulness-Based Yoga Intervention for Justice-Involved Youth.

The purpose of the present study was to adapt and pilot a trauma-informed, mindfulness-based yoga (TIMBY) intervention focused on enhancing self-regulation among youth in the Georgia Department of Juvenile Justice system. In this article we (1) describe the process by which we systematically adapted an evidence-based protocol specifically for this population, (2) describe the nature of and rationale for those adaptations, (3) present some preliminary qualitative findings based on interviews with youth participants, and (4) briefly summarize how the adapted protocol will be evaluated in the subsequent feasibility trial. The iterative drafting and revision process involved modifications to a well-established, protocolized Trauma-Informed Yoga program and was identified by the project advisory board and t h rough formal interviews with intervention staff. Qualitative interviews were conducted with youth participants concerning intervention impact, credibility, and satisfaction. Several needed modifications were identified so that the intervention would be contextually appropriate for justice-involved youth. Thirty youth were enrolled in the pilot study: 77% we re Non - Hispanic Black/African-American, 18% were Non-Hispanic White, and 5% were Hispanic White. The average age was 16.45 years (range 14-20). The youth consistently reported satisfaction with the sessions and positive beliefs about how the sessions were helping them with a range of physical and psychological/ emotional challenges. Adaptations to the protocol in the present study highlight how mindfulness-based interventions for justice-involved youth need to consider what is both developmentally suitable for youth and appropriate in a justice setting. A feasibility study using this revised TIMBY protocol is underway at four Georgia Department of Juvenile Justice facilities to formally identify the barriers and facilitators to implementation for the present study and a future, larger-scale trial.

"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.

Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating.

OBJECTIVE: Cognitive-behavioral therapy (CBT) has shown efficacy in the treatment of eating disorders. The authors conducted a randomized controlled telemedicine trial of CBT-guided self-help (CBT-GSH) assisted with a smartphone app, Noom Monitor, for binge eating with or without purging. They hypothesized that coach-delivered CBT-GSH telemedicine sessions plus Noom Monitor would yield greater reductions in symptoms of binge eating, purging, and eating disorders compared with standard care. METHODS: Fifty-two-week outcomes for CBT-GSH plus Noom Monitor (N=114) were compared with outcomes for standard care (N=111) among members of an integrated health care system in the Pacific Northwest. Patients in the health system who met inclusion criteria were ≥18 years old, had a body mass index ≥18.5, met criteria for DSM-5 binge eating disorder or bulimia nervosa, had 12 months of continuous health care enrollment in Kaiser Permanente Northwest, and had a personal smartphone. Participants received eight CBT-GSH telemedicine sessions over 12 weeks administered by health coaches, and outcomes were assessed at baseline and at weeks 4, 8, 12, 26, and 52. The use of available treatment offered within the Kaiser Permanente health care system was permitted for participants assigned to standard care. RESULTS: Participants who received CBT-GSH plus Noom Monitor reported significant reductions in objective binge-eating days (ß=-0.66, 95% CI=-1.06, -0.25; Cohen's d=-1.46, 95% CI=-4.63, -1.09) and achieved higher rates of remission (56.7% compared with 30%; number needed to treat=3.74) at 52 weeks compared with participants in standard care, none of whom received any eating disorder treatment during the intervention period (baseline and weeks 1-12). Similar patterns emerged for compensatory behaviors (vomiting, use of laxatives, and excessive exercise; 76.3% compared with 56.8%; number needed to treat=5.11), eating disorder symptoms (body shape, weight, eating concerns, and dietary restraint), and clinical impairment (Cohen's d=-10.07, -2.15). CONCLUSIONS: These results suggest that CBT-GSH plus Noom Monitor delivered via telemedicine by routine-practice health coaches in a nonacademic health care system yields reductions in symptoms and impairment over 52 weeks compared with standard care.

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.

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

BACKGROUND: Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE: To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN: Prospective cohort study using propensity score-matched controls. PARTICIPANTS: Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES: Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS: Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS: We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Clinical Policy Recommendations from the VHA State-of-the-Art Conference on Non-Pharmacological Approaches to Chronic Musculoskeletal Pain.

As a large national healthcare system, Veterans Health Administration (VHA) is ideally suited to build on its work to date and develop a safe, evidence-based, and comprehensive approach to the care of chronic musculoskeletal pain conditions that de-emphasizes opioid use and emphasizes non-pharmacological strategies. The VHA Office of Health Services Research and Development (HSR&D) held a state-of-the-art (SOTA) conference titled "Non-pharmacological Approaches to Chronic Musculoskeletal Pain Management" in November 2016. Goals of the conference were (1) to establish consensus on the current state of evidence regarding non-pharmacological approaches to chronic musculoskeletal pain to inform VHA policy in this area and (2) to begin to identify priorities for the future VHA research agenda. Workgroups were established and asked to reach consensus recommendations on clinical and research priorities for the following treatment strategies: psychological/behavioral therapies, exercise/movement therapies, manual therapies, and models for delivering multimodal pain care. Participants in the SOTA identified nine non-pharmacological therapies with sufficient evidence to be implemented across the VHA system as part of pain care. Participants further recommended that effective integration of these non-pharmacological approaches across the VHA and especially into VHA primary care, pain care, and mental health settings should be a priority, and that these treatments should be offered early in the course of pain treatment and delivered in a team-based, multimodal treatment setting concurrently with active self-care and self-management approaches. In addition, we recommend that VHA leadership and policy makers systematically address the barriers to implementation of these approaches by expanding opportunities for clinician and veteran education on the effectiveness of these strategies; supporting and funding further research to determine optimal dosage, duration, sequencing, combination, and frequency of treatment; emphasizing multimodal care with rigorous evaluation grounded in team-based approaches to test integrated models of delivery and stepped-care approaches; and working to address socioeconomic and cultural barriers to veterans' access to non-pharmacological approaches.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. METHODS/DESIGN: This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. DISCUSSION: This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.

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.

The feasibility of matching on a propensity score for acupuncture in a prospective cohort study of patients with chronic pain.

BACKGROUND: Propensity scores are typically applied in retrospective cohort studies. We describe the feasibility of matching on a propensity score derived from a retrospective cohort and subsequently applied in a prospective cohort study of patients with chronic musculoskeletal pain before the start of acupuncture or usual care treatment and enrollment in a comparative effectiveness study that required patient reported pain outcomes. METHODS: We assembled a retrospective cohort study using data from 2010 to develop a propensity score for acupuncture versus usual care based on electronic healthcare record and administrative data (e.g., pharmacy) from an integrated health plan, Kaiser Permanente Northwest. The propensity score's probabilities allowed us to match acupuncture-referred and non-referred patients prospectively in 2013-14 after a routine outpatient visit for pain. Among the matched patients, we collected patient-reported pain before treatment and during follow-up to assess the comparative effectiveness of acupuncture. We assessed balance in patient characteristics with the post-matching c-statistic and standardized differences. RESULTS: Based on the propensity score and other characteristics (e.g., patient-reported pain), we were able to match all 173 acupuncture-referred patients to 350 non-referred (usual care) patients. We observed a residual imbalance (based on the standardized differences) for some characteristics that contributed to the score; for example, age, -0.283, and the Charlson comorbidity score, -0.264, had the largest standardized differences. The overall balance of the propensity score appeared more favorable according to the post-matching c-statistic, 0.503. CONCLUSION: The propensity score matching was feasible statistically and logistically and allowed approximate balance on patient characteristics, some of which will require adjustment in the comparative effectiveness regression model. By transporting propensity scores to new patients, healthcare systems with electronic health records can conduct comparative effectiveness cohort studies that require prospective data collection, such as patient-reported outcomes, while approximately balancing numerous patient characteristics that might confound the benefit of an intervention. The approach offers a new study design option.

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.

Acupuncture and chiropractic care: utilization and electronic medical record capture.

OBJECTIVES: To describe acupuncture and chiropractic use among patients with chronic musculoskeletal pain (CMP) at a health maintenance organization, and explore issues of benefit design and electronic medical record (EMR) capture. STUDY DESIGN: Cross-sectional survey. METHODS: Kaiser Permanente members meeting EMR diagnostic criteria for CMP were invited to participate. The survey included questions about self-identified presence of CMP, use of acupuncture and chiropractic care, use of ancillary self-care modalities, and communication with conventional medicine practitioners. Analysis of survey data was supplemented with a retrospective review of EMR utilization data. RESULTS: Of 6068 survey respondents, 32% reported acupuncture use, 47% reported chiropractic use, 21% used both, and 42% used neither. For 25% of patients using acupuncture and 43% of those using chiropractic care, utilization was undetected by the EMR. Thirty-five percent of acupuncture users and 42% of chiropractic users did not discuss this care with their health maintenance organization (HMO) clinicians. Among chiropractic users, those accessing care out of plan were older (P < .01), were more likely to use long-term opioids (P = .03), and had more pain diagnoses (P = .01) than those accessing care via clinician referral or self-referral. For acupuncture, those using the clinician referral mechanism exhibited these same characteristics. CONCLUSIONS: A majority of participants had used acupuncture, chiropractic care, or both. While benefit structure may materially influence utilization patterns, many patients with CMP use acupuncture and chiropractic care without regard to their insurance coverage. A substantial percentage of acupuncture and chiropractic use thus occurs beyond detection of EMR systems, and many patients do not report such care to their HMO clinicians.

Pharmacotherapy for incident attention-deficit/hyperactivity disorder: practice patterns and quality metrics.

INTRODUCTION: This study examines incident treatment patterns for attention-deficit/hyperactivity disorder (ADHD) in children seen in eight integrated healthcare delivery systems and identifies factors associated with adherence to Healthcare Effectiveness Data and Information Set (HEDIS) quality measures developed by the National Committee for Quality Assurance (NCQA). METHOD: A retrospective cohort analysis using electronic healthcare data from children aged 3 through 17 years with newly diagnosed ADHD between January 1, 2009 and December 31, 2010 was conducted. NCQA quality definitions for initiation and for continuation and maintenance (C&M) of ADHD medications were expanded to include preschoolers and adolescents. Poisson regression models with robust error variance were used to evaluate the association between NCQA HEDIS adherence measures, provider type, patient characteristics and care process measures. RESULTS: Of 6864 children aged 3-17 years old qualifying for incident treatment analyses, 5538 (80.7%) were started on ADHD medication within a year of diagnosis. Adherence to NCQA HEDIS measures was 49.8% for initiation and 45.8% for C&M, with adherence rates higher for mental health than non-mental health providers, school-aged children than adolescents, and for patients concurrently on other psychotropic medications than those who were not. Of those started on ADHD medication, 62.3% were not eligible for C&M analyses according to HEDIS guidelines, because they did not receive continuous (210 of 300 days) ADHD medication treatment, with adolescents less likely than school-aged children to persist with medications. CONCLUSION: Study limitations must be considered, including reliance on electronic medical record data, absence of patient race and sociodemographic data, and limited generalizability to other care contexts. Nevertheless, findings suggest novel strategies are needed to improve the quality of ADHD care processes for children of all ages, because even within integrated delivery systems less than half of children with ADHD received care consistent with NCQA HEDIS standards for initiation and C&M care. RESULTS suggest the need to refine quality measures by including follow-up care in those children not receiving or discontinuing medication treatment, a considerable quality concern not currently captured in NCQA HEDIS standards.

Use of alternative medicine for weight loss among Mexican-American women.

The objective of this study is to examine the use of complementary and alternative medicine (CAM) for weight loss among Mexican-American women. Cross-sectional survey of different CAM modalities, including traditional Mexican medicine therapies. The sample was drawn from women participating in a weight-loss program in Portland, Oregon. Sample consisted of 31 adult Mexican-American women. Most respondents reported using some form of CAM for weight loss, with most reporting using herbs and teas (70 %), home remedies (61 %) and massage (55 %). Mexican-American women report using a wide range of CAM therapies for weight loss. Understanding their patterns of use will enhance cultural competence of health care professionals and help address their medical needs.

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.