Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports.

BACKGROUND: Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. OBJECTIVES: To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. RESEARCH DESIGN: Time and cost estimation associated with implementing the LIRE intervention in a health organization. SUBJECTS: Providers and patients assessed in the LIRE trial. MEASURES: Expected personnel costs required to implement the LIRE intervention. RESULTS: Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. CONCLUSIONS: The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.

The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial.

Importance: Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions. Objective: To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions. Design, Setting, and Participants: This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019. Interventions: Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group). Main Outcomes and Measures: Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality. Results: We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, -0.7%; 95% CI, -2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, -29.3%; 95% CI, -42.1% to -13.5%; magnetic resonance imaging: difference, -3.4%; 95% CI, -8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04). Conclusions and Relevance: In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented. Trial Registration: ClinicalTrials.gov Identifier: NCT02015455.

Design of a Multidisciplinary Training Program in Complementary and Integrative Health Clinical Research: Building Research Across Interdisciplinary Gaps.

Despite wide use by the public, limited evidence is available for many complementary and integrative health (CIH) practices. Thus, clinical researchers knowledgeable about CIH disciplines are necessary to study the efficacy and effectiveness of CIH practices to benefit the public health. To partially address the need for clinical researchers versed in CIH, the authors of this study report the design of an interprofessional clinical research training program focused on CIH, the Building Research across Interdisciplinary Gaps (BRIDG) program, supported by a 5-year T90/R90 grant from the National Center for Complementary and Integrative Health. The T90-supported arm of the program trains doctoral-level CIH providers in clinical research at the research-intensive University of Washington. The R90-supported arm of the program trains researchers with conventional backgrounds in the practices of CIH at the clinic-intensive National University of Natural Medicine. The "Translational Science Spectrum" provides a common conceptual framework for both programs. Specific program elements include: individualized didactic training in clinical research and CIH disciplines; placement with clinical research mentors; placement with clinical mentors in CIH disciplines; shared and independent research project development; and interdisciplinary experiences through seminars and retreats. Program evaluation includes annual completion of the Clinical Research Appraisal Inventory (CRAI), which queries confidence in research skills and methods and periodic evaluation of training elements using the Supplemental Kellogg Logic-World Health Organization model, which emphasizes relevance, adequacy, efficiency, effectiveness, process, impact, equity, and sustainability. The BRIDG program exemplifies a new standard in interprofessional clinical research training, made possible through strong collaboration between disparate research- and clinically intensive institutions.

Impact of Chronic Opioid Therapy Risk Reduction Initiatives on Opioid Overdose.

We assessed the effects of opioid dose and risk reduction initiatives on opioid overdose rates among patients on chronic opioid therapy (COT). Using an interrupted time series design, we compared trends in overdose rates. We compared patients on COT in settings that implemented a COT dose reduction initiative and then a COT risk stratification/monitoring initiative to similar patients on COT from control settings. From 2006 to 2014, 31,142 patients on COT (22,673 intervention, 8,469 control) experienced 311 fatal or nonfatal opioid overdoses. In primary analyses, changes in opioid overdose rates among patients on COT did not differ significantly between intervention and control settings with the implementation of either dose reduction or risk stratification/monitoring. In planned secondary analyses, overdose rates decreased significantly (17% per year) during the dose reduction initiative among patients on COT in intervention settings (relative annual change, 0.83; 95% confidence interval, 0.70-0.99), but not in control settings (0.98. 95% confidence interval, 0.70-1.39). We conclude that overdose rates among patients on COT were not decreased by risk stratification and monitoring initiatives. Results were inconsistent for COT dose reduction, with no significant difference between intervention and control settings (primary hypothesis test), but a significant decrease in overdose rates within the intervention setting during dose reduction (secondary hypothesis test). PERSPECTIVE: Risk stratification/monitoring interventions among patients on COT did not decrease opioid overdose rates. The effects of COT dose reduction on opioid overdose rates were inconsistent. Greater decreases in COT dose, a larger control group, or both may have been needed to identify conclusive reductions in opioid overdose rates.

Impact of initiatives to reduce prescription opioid risks on medically attended injuries in people using chronic opioid therapy.

PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates. RESULTS: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings. CONCLUSIONS: Risk reduction initiatives did not decrease injuries in people using COT.

Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation.

OBJECTIVE: To support implementation of effective treatments for back pain that can be delivered to a range of people, we summarize learnings from our process evaluation of the MATCH trial's implementation of an adaptation of the STarT Back risk-stratified care model. DESIGN: Our logic model-driven evaluation focused primarily on qualitative data sources. SETTING: This study took place in a US-based health care delivery system that had adapted and implemented the STarT Back stratified care approach. This was the first formal test of the strategy in a US setting. METHODS: Data collection included observation of implementation activities, staff/provider interviews, and post-training evaluation questionnaires. Data were analyzed using thematic analysis of qualitative data and descriptive statistics for questionnaire data. RESULTS: We found that both primary care teams and physical therapists at intervention clinics gave the training high scores on evaluation questionnaires and reported in the interviews that they found the training engaging and useful. However, there was significant variation in the extent to which the risk stratification strategy was incorporated into care. Some primary care providers reported that the intervention changed their conversations with patients and increased their confidence in working with patients with back pain. Providers using the STarT Back tool did not change referral rates for recommended matched treatments. CONCLUSIONS: These insights provide guidance for future efforts to adapt and implement the STarT Back strategy and other complex practice change interventions. They emphasize the need for primary care-based interventions to minimize complexity and the need for ongoing monitoring and feedback.

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

BACKGROUND: The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England. OBJECTIVE: This trial evaluated the effect of implementing an adaptation of this approach in a US setting. DESIGN: The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. PARTICIPANTS: Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later. INTERVENTIONS: The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients' risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training. MAIN MEASURES: Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. KEY RESULTS: Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. CONCLUSIONS: A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. TRIAL REGISTRATION: National Clinical Trial Number NCT02286141.

Cost-effectiveness of Mindfulness-based Stress Reduction Versus Cognitive Behavioral Therapy or Usual Care Among Adults With Chronic Low Back Pain.

STUDY DESIGN: Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP). OBJECTIVE: To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC. SUMMARY OF BACKGROUND DATA: CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored. METHODS: A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization. RESULTS: Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR. CONCLUSION: In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society. LEVEL OF EVIDENCE: 2.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. METHODS/DESIGN: This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. DISCUSSION: This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02224183.

Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience.

BACKGROUND: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. PURPOSE: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. METHODS: Women from three geographic areas with a weekly average of ≥14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. RESULTS: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2% CONCLUSIONS: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.

Effect of risk adjustment method on comparisons of health care utilization between complementary and alternative medicine users and nonusers.

OBJECTIVES: Complementary and alternative medicine (CAM) providers are becoming more integrated into the United States health care system. Because patients self-select CAM use, risk adjustment is needed to make the groups more comparable when analyzing utilization. This study examined how the choice of risk adjustment method affects assessment of CAM use on overall health care utilization. DESIGN AND SUBJECTS: Insurance claims data for 2000-2003 from Washington State, which mandates coverage of CAM providers, were analyzed. Three (3) risk adjustment methods were compared in patients with musculoskeletal conditions: Adjusted Clinical Groups (ACG), Diagnostic Cost Groups (DCG), and the Charlson Index. Relative Value Units (RVUs) were used as a proxy for expenditures. Two (2) sets of median regression models were created: prospective, which used risk adjustments from the previous year to predict RVU in the subsequent year, and concurrent, which used risk adjustment measures to predict RVU in the same year. RESULTS: The sample included 92,474 claimants. Prospective models showed little difference in the effect of CAM use on RVU among the three risk adjustment methods, and all models had low predictive power (R(2) ≤0.05). In the concurrent models, coefficients were similar in direction and magnitude for all risk adjustment methods, but in some models the predicted effect of CAM use on RVU differed by as much as double between methods. Results of DCG and ACG models were similar and were stronger than Charlson models. CONCLUSIONS: Choice of risk adjustment method may have a modest effect on the outcome of interest.

The association of complementary and alternative medicine use and health care expenditures for back and neck problems.

BACKGROUND: Health care costs associated with use of complementary and alternative medicine (CAM) by patients with spine problems have not been studied in a national sample. OBJECTIVES: To estimate the total and spine-specific medical expenditures among CAM and non-CAM users with spine problems. RESEARCH DESIGN: Analysis of the 2002-2008 Medical Expenditure Panel Survey. SUBJECTS: Adults (above 17 y) with self-reported neck and back problems who did or did not use CAM services. MEASURES: Survey-weighted generalized linear regression and propensity matching to examine expenditure differences between CAM users and non-CAM users while controlling for patient, socioeconomic, and health characteristics. RESULTS: A total of 12,036 respondents with spine problems were included, including 4306 (35.8%) CAM users (40.8% in weighted sample). CAM users had significantly better self-reported health, education, and comorbidity compared with non-CAM users. Adjusted annual medical costs among CAM users was $424 lower (95% confidence interval: $240, $609; P<0.001) for spine-related costs, and $796 lower (95% confidence interval: $121, $1470; P = 0.021) for total health care cost than among non-CAM users. Average expenditure for CAM users, based on propensity matching, was $526 lower for spine-specific costs (P<0.001) and $298 lower for total health costs (P = 0.403). Expenditure differences were primarily due to lower inpatient expenditures among CAM users. CONCLUSIONS: CAM users did not add to the overall medical spending in a nationally representative sample with neck and back problems. As the causal associations remain unclear in these cross-sectional data, future research exploring these cost differences might benefit from research designs that minimize confounding.

Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year.

BACKGROUND: Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes. METHODS: Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. RESULTS: Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by -0.90 % (P = 0.02) in the ANC cohort at 6-months, a -0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (-0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12). CONCLUSIONS: Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.

Patient and clinician openness to including a broader range of healing options in primary care.

PURPOSE: We studied the openness of patients and clinicians to introducing a broader range of healing options into primary care. METHODS: Focus groups were conducted with primary care patients (4 groups) and clinicians (3 groups) from an integrated medical care system in 2008. Transcripts of discussions were analyzed using an immersion/crystallization approach. RESULTS: Both patients (n = 44) and clinicians (n = 32) were open to including a wider variety of healing options in primary care. Patients desired some evidence of effectiveness, although there was wide variation in the type of evidence required. Many patients believed that the clinician's personal and practice experience was an important form of evidence. Patients wanted to share in the decision to refer and the choice of options. Clinicians were most concerned with safety of specific treatments, including some of the herbs and dietary supplements. They also believed they lacked adequate information about the nature, benefits, and risks of many alternatives, and they were not aware of local practitioners and resources to whom they could confidently refer their patients. Both patients and clinicians were concerned that services recommended be covered by insurance or be affordable to patients. CONCLUSIONS: Integrating additional healing options into primary care may be feasible and desirable, as well as help meet the needs of patients with conditions that have not been responsive to standard medical treatments.

A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial.

BACKGROUND: Few studies have evaluated the effectiveness of massage for chronic low back pain. OBJECTIVE: To compare the effectiveness of 2 types of massage and usual care for chronic back pain. DESIGN: Parallel-group randomized, controlled trial. Randomization was computer-generated, with centralized allocation concealment. Participants were blinded to massage type but not to assignment to massage versus usual care. Massage therapists were unblinded. The study personnel who assessed outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00371384) SETTING: An integrated health care delivery system in the Seattle area. PATIENTS: 401 persons 20 to 65 years of age with nonspecific chronic low back pain. INTERVENTION: Structural massage (n = 132), relaxation massage (n = 136), or usual care (n = 133). MEASUREMENTS: Roland Disability Questionnaire (RDQ) and symptom bothersomeness scores at 10 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes). Mean group differences of at least 2 points on the RDQ and at least 1.5 points on the symptom bothersomeness scale were considered clinically meaningful. RESULTS: The massage groups had similar functional outcomes at 10 weeks. The adjusted mean RDQ score was 2.9 points (95% CI, 1.8 to 4.0 points) lower in the relaxation group and 2.5 points (CI, 1.4 to 3.5 points) lower in the structural massage group than in the usual care group, and adjusted mean symptom bothersomeness scores were 1.7 points (CI, 1.2 to 2.2 points) lower with relaxation massage and 1.4 points (CI, 0.8 to 1.9 points) lower with structural massage. The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks but were small. LIMITATION: Participants were not blinded to treatment. CONCLUSION: Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months. No clinically meaningful difference between relaxation and structural massage was observed in terms of relieving disability or symptoms. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine.

Insurance coverage and subsequent utilization of complementary and alternative medicine providers.

BACKGROUND: Since 1996, Washington State law has required that private health insurance cover licensed complementary and alternative medicine (CAM) providers. OBJECTIVE: To evaluate how insured people used CAM providers and what role this played in healthcare utilization and expenditures. STUDY DESIGN: Cross-sectional analysis of insurance enrollees from western Washington in 2002. METHODS: Analysis of insurance demographic data, claims files, benefit information, diagnoses, CAM and conventional provider utilization, and healthcare expenditures for 3 large health insurance companies. RESULTS: Among more than 600,000 enrollees, 13.7% made CAM claims. This included 1.3% of enrollees with claims for acupuncture, 1.6% for naturopathy, 2.4% for massage, and 10.9% for chiropractic. Patients enrolled in preferred provider organizations and point-of-service products were notably more likely to use CAM than those with health maintenance organization coverage. The use of CAM was greater among women and among persons 31 to 50 years of age. The use of chiropractic was more frequent in less populous counties. The CAM provider visits usually focused on musculoskeletal complaints except for naturopathic physicians, who treated a broader array of problems. The median per-visit expenditures were 39.00 dollars for CAM care and 74.40 dollars for conventional outpatient care. The total expenditures per enrollee were 2589 dollars, of which 75 dollars(2.9%) was spent on CAM. CONCLUSIONS: The number of people using CAM insurance benefits was substantial; the effect on insurance expenditures was modest. Because the long-term trajectory of CAM cost under third-party payment is unknown, utilization of these services should be followed.

The role of alternative medical providers for the outpatient treatment of insured patients with back pain.

STUDY DESIGN: Analysis of health insurance claims from 2 large Washington State companies. OBJECTIVE: To evaluate the prevalence and cost of complementary and alternative medicine (CAM) provider use for back pain treatment. SUMMARY OF BACKGROUND DATA: Washington State requires all commercial insurance to cover licensed CAM providers. METHODS: Outpatient claims for the treatment of back pain were analyzed by the International Classification of Disease-9 codes and provider type. The number of visits and expenditures associated with different forms of treatments were calculated. RESULTS: Back pain accounted for 15% of all outpatient visits, and these companies spent more than $52 million on 652,593 claims submitted by 104,358 adults. Most people used only CAM (43%) or only conventional providers (45%) for back pain treatment, with merely 12% using both. Patients who saw only CAM providers had fewer comorbidities than the other 2 groups and made approximately twice as many visits as "conventional only" users (median 4 vs. 2). Average amount allowed per outpatient low back pain claim was lower for CAM visits (mean $50, SD $28) than for conventional visits (mean $128, SD $173). Total outpatient costs for the treatment of back pain were highest for the group using both CAM and conventional care (mean $1079, SD $1185), and lowest for the group using CAM only (mean $342, SD $429). CONCLUSION: Many people with back pain use only CAM for their treatment. Although less expensive, this group also appears to be less severely ill. Because of the high prevalence of this condition, cost-effectiveness studies that include CAM therapies are still warranted.

A survey of training and practice patterns of massage therapists in two US states.

BACKGROUND: Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics. METHODS: As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits). RESULTS: Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians. CONCLUSION: This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy.