Development and Implementation of a Flexible Yoga Therapy Protocol in the Group Acupuncture Therapy and Modified Yoga (GAPYOGA) Pilot Study.

Chronic pain is the most common reason U.S. adults seek medical care. Acupuncture and yoga show effectiveness, and a recent study assessed the feasibility of these two modalities for chronic pain at federally qualified health centers. Yoga research is rarely individualized, which is important for chronic pain treatments. Six experienced yoga professionals drew on research and clinical experience to co-create a yoga therapy protocol standardized for replication with flexibility for individual care. Yoga therapy was to be combined with a previously developed flexible acupuncture intervention in a feasibility trial. Categories of practices were identified as relevant and appropriate for chronic pain management in a federally qualified health center. Within each category, specific practices were listed for each provider to select as appropriate. These were based on usefulness for chronic pain, safety, ease of teaching/learning, and cultural appropriateness. The final manual included: (1) stabilizing poses, (2) mobilizing poses, (3) breathing practices, (4) relaxation, (5) mental practices, and (6) applied philosophy. Each participant began with an intake to inform practice selection. Ten subsequent sessions were 30 minutes each, with 1-2 participants receiving simultaneous care. First sessions included diaphragmatic breathing and some physical postures. All practices were adapted. Over 10 sessions, at least one practice from each category was included. Participants were given instructions/images for home practice. Individual charting ensured continuity of care and consistency across sessions. In evidence-informed practice, there exists a tension between replicability and individualization. A flexible protocol allows both. Future application in research and clinical settings will help to determine feasibility and effectiveness.

Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Settings for an Underserved Population: A Feasibility Pilot Study.

Background: Acupuncture and yoga have both been shown to be effective in chronic pain. Underrepresented populations have poorer pain outcomes with less access to effective pain care. Objective: To assess the feasibility of bundling group acupuncture with yoga therapy for chronic neck, back or osteoarthritis pain in safety net settings. Methods: This was a feasibility pilot in Bronx and Harlem primary care community health centers. Participants with chronic neck, back or osteoarthritis pain received acupuncture and yoga therapy over a 10-week period. Participants received 10 weekly acupuncture treatments in group setting; with Yoga therapy sessions beginning immediately following the 3rd session. Primary outcome was pain interference and pain intensity on the Brief Pain Inventory (BPI); Outcomes were measured at baseline, 10-week close of intervention, and 24-week follow-up. Results: 93 patients were determined to be eligible and completed the baseline interview. The majority of participants were non-White and Medicaid recipients. 78 (84%) completed the intervention and 10-week survey, and 58 (62%) completed the 24-week post intervention survey. Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. Patients showed statistically significant improvements in pain at the close of the intervention and at a somewhat lesser rate, at 24-weeks post intervention. Challenges included telephone outreach and site coordination integrating acupuncture with yoga therapy. The trial also had to be stopped early due to the COVID-19 pandemic. Conclusions: Bundling acupuncture therapy and yoga therapy is feasible for an underrepresented population with chronic pain in urban community health centers with preliminary indications of acceptability and benefit to participants.

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.

Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool.

BACKGROUND: Primary care providers manage most patients with chronic pain. Pain is a complex problem, particularly in underserved populations. A technology-enabled, point-of-care decision support tool may improve pain management outcomes. METHODS: We created an electronic health record (EHR)-based decision support tool, the Pain Management Support System-Primary Care (PMSS-PC), and studied the tool-plus-education in 6 Federally Qualified Health Center practices using a randomized, wait-list controlled design. The PMSS-PC generated "best practice alerts," gave clinicians access to a pain assessment template, psychological distress and substance use measures, guidelines for drug and non-drug therapies, and facilitated referrals. Practices were randomly assigned to early vs delayed (after 6 months) implementation of the intervention, including technical support and 6 webinars. The primary outcome was change in worst pain intensity scores after 6 months, assessed on the Brief Pain Inventory-Short Form. Changes in outcomes were compared between the practices using linear multilevel modeling. The EHR provided clinician data on PMSS-PC utilization. RESULTS: The 256 patients in the early implementation practices had significantly improved worst pain (standardized effect size [ES] = -.32) compared with the 272 patients in the delayed implementation practices (ES = -.11). There was very low clinician uptake of the intervention in both conditions. CONCLUSIONS: Early implementation of the PMSS-PC improved worst pain, but this effect cannot be attributed to clinician use of the tool. Further PMSS-PC development is not indicated, but practice-level interventions can improve pain, and studies are needed to identify the determinants of change.

Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot.

Objective: To identify factors associated with implementing bundled group acupuncture and yoga therapy (YT) to treat underserved patients with chronic pain in community health center (CHC) settings. This is not an implementation science study, but rather an organized approach for identification of barriers and facilitators to implementing these therapies as a precursor to a future implementation science study. Design: This study was part of a single-arm feasibility trial, which aimed to test the feasibility of bundling GA and YT for chronic pain in CHCs. Treatment outcomes were measured before and after the 10-week intervention period. Implementation feasibility was assessed through weekly research team meetings, weekly yoga provider meetings, monthly acupuncture provider meetings, and weekly provider surveys. Settings: The study was conducted in New York City at two Montefiore Medical Group (MMG) sites in the Bronx, and one Institute for Family Health (IFH) site in Harlem. Subjects: Participants in the feasibility trial were recruited from IFH and MMG sites, and needed to have had lower back, neck, or osteoarthritis pain for >3 months. Implementation stakeholders included the research team, providers of acupuncture and YT, referring providers, and CHC staff. Results: Implementation of these therapies was assessed using the Consolidated Framework for Implementation Research. We identified issues associated with scheduling, treatment fidelity, communication, the three-way disciplinary interaction of acupuncture, yoga, and biomedicine, space adaptation, site-specific logistical and operational requirements, and patient-provider language barriers. Issues varied as to their frequency and resolution difficulty. Conclusions: This feasibility trial identified implementation issues and resolution strategies that could be further explored in future implementation studies. Clinical Trial Registration No.: NCT04296344.

Integrative medicine smart phrase pilot study: Evaluating an EHR tool to improve providers' attitudes, knowledge and use of herbal and dietary supplements.

CONTEXT: While many patients use herbal and dietary supplements (H/DS) for wellness, disease prevention and treatment, providers still cite a lack of resources and formal training as barriers to responding to patients' inquiries about H/DS. Although the federal government, academic institutions and the private sector now offer more opportunities for education and research on H/DS, greater support in real time is needed to facilitate providers during the clinical encounter. OBJECTIVE: This small, pilot study evaluates the effects of implementation of smart phrases in the electronic health record (EHR) and an educational intervention on providers' knowledge, attitude and use of H/DS in the clinical encounter. DESIGN, SETTING AND PARTICIPANTS: The study was conducted at The Institute for Family Health (IFH), a Federally Qualified Health Center and academic health center which operates the Department of Family Medicine and Community Health in affiliation with the Icahn School of Medicine at Mount Sinai. Baseline and post-intervention surveys were conducted to explore providers' attitudes, knowledge and use of integrative medicine (IM) smart phrases on H/DS. MAIN OUTCOME MEASURES: Providers' awareness of smart phrases of H/DS, knowledge of the content, confidence in using smart phrases to discuss H/DS, self-reported use of smart phrases were measured. RESULTS: A total of 32 subjects participated in the intervention and completed the baseline survey. Only half of the participants were familiar with the IM smart phrases in our system and 12.5% felt they were aware of the information covered in these smart phrases. Eighteen of 32 participants completed the post-intervention assessment. The intervention was successful in statistically increasing participants' self-reported awareness of the information covered in the IM smart phrases (p<0.01). Increased confidence in using IM smart phrases to initiate patients on a new supplement showed statistical significance (p=0.03). There were no clear patterns in reported behavior changes following the training with the exception of a significant increase in the self-reported frequency of past month use of IM smart phrases during a patient visit (p=0.01). Lastly, there were no changes in the frequency of smart phrase use in the EHR. CONCLUSION: The implementation and adoption of evidence-based use of H/DS in the clinical encounter requires a sustained educational component to make the availability of smart phrases via technology (EHR) an effective strategy.

A Randomized Trial of a Group-Based Integrative Medicine Approach Compared to Waitlist Control on Irritable Bowel Syndrome Symptoms in Adults.

INTRODUCTION: Irritable bowel syndrome (IBS) is a chronic debilitating functional gastrointestinal disorder that affects a large proportion of the general population. Dietary and mind-body approaches have shown some effectiveness in reducing IBS symptoms. OBJECTIVES: The purpose of this project was to test the feasibility of a low cost, group-oriented integrative medicine approach to IBS, and to explore whether such an approach improves participant outcomes. METHODS: This was a randomized-controlled trial involving a 4-week group-oriented treatment intervention combining dietary intervention and mind-body therapies followed by 8-weeks of telephonic health coaching. Differences between the intervention and control groups on IBS-specific measures were examined at baseline, 4, 8, and 12-week. RESULTS: Fifty-two participants completed the study, 30 in the control group and 22 in the intervention group. On the IBS Symptom Severity Score, at 4 weeks the intervention group showed statistically significant improvement compared to the control group (p < .02), which was sustained at the 8 and 12-week data points as well, with the proportion of the intervention group experiencing moderate to severe symptoms decreasing from 81.3% at baseline to 45% at week 4 and 54.5% at week 12. A statistically significant improvement was also seen on the CES-D measure of depression between baseline and week 12 in the intervention group compared to controls. On the IBS Quality of Life measure we did not observe a statistically significant difference between the groups. CONCLUSIONS: This low-cost, group-oriented intervention approach offers a strategy to address the challenge of access to this type of integrative approach for patients of low socioeconomic status or limited means.

Race and Ethnicity Do Not Clinically Associate with Quality of Life Among Patients with Chronic Severe Pain in a Federally Qualified Health Center.

Objective: Previous research suggests that race/ethnicity predicts health-related quality of life (HRQL) in chronic pain populations but has not examined this in community settings. This study evaluated this association in 522 community-dwelling patients with chronic pain treated at a Federally Qualified Health Center (FQHC). Design: Cross-sectional secondary analysis. Setting: Six practice sites of an FQHC in New York. Subjects: One hundred forty-two non-Hispanic blacks, 121 non-Hispanic whites, 219 Hispanics, and 40 classified as "other" with severe chronic pain. Methods: Patients with chronic severe pain (three or more months with worst pain ≥ 4/10 or T-score > 60.5 on the Patient-Reported Outcomes Measurement Information System pain interference tool) were interviewed as part of a clinical trial. Race/ethnicity and other potential predictors of HRQL were assessed. Results: Mean age was 53.0 years, and 70.1% were women; 62.8% earned less than $10,000 per year, and 22.8% were Spanish-speaking with low acculturation. Mean worst pain during the past week was 8.6/10, and 39.6% used opioids. In multivariate analyses, race/ethnicity was not significantly associated with mental HRQL. Hispanics had significantly lower physical HRQL than non-Hispanic whites or blacks, but this difference was not clinically meaningful (mean T-scores = 33.9 [Hispanics], 35.8 [non-Hispanic whites], and 35.6 [non-Hispanic blacks]). Mental HRQL was predicted by depression, anxiety, pain disability, income, and physical HRQL; physical HRQL was predicted by race/ethnicity, anxiety, pain disability, age, care satisfaction, and mental HRQL. Conclusions: Race/ethnicity does not explain important variation in HRQL reported by diverse patients with chronic pain. Psychological distress, pain disability, age, and socioeconomic status predicted this health outcome. Future studies may clarify modifiers of these associations to guide treatment in FQHC populations.

Integrative Medicine in Residency: Feasibility and Effectiveness of an Online Program.

BACKGROUND AND OBJECTIVES: Online curricular interventions in residency have been proposed to address challenges of time, cost, and curriculum consistency. This study is designed to determine the feasibility and effectiveness of a longitudinal, multisite online curriculum in integrative medicine (IMR) for residents. METHODS: Residents from eight family medicine programs undertook the 200-hour online IMR curriculum. Their medical knowledge (MK) scores at completion were compared to a control group from four similar residency programs. Study and control groups were comparable in baseline demographics, and MK scores. Course completion, MK scores, and course evaluations were assessed. RESULTS: Of 186 IMR residents, 76.9% met completion requirements. The IMR group showed statistically significant higher MK scores at residency completion, the control group did not (IMR: 79.2% vs. CONTROL: 53.2% mean correct). Over three-fourths of IMR participants (range 79-92%) chose the top two rating categories for each course evaluation item. In an exit survey, ability to access the curriculum for 1 additional year and intention to utilize IM approaches after residency were the highest ranked items. CONCLUSIONS: The demonstrated feasibility, effectiveness, and positive evaluations of the IMR curriculum indicate that a multisite, online curricular intervention is a potentially viable approach to offering new curriculum with limited on-site faculty expertise for other family medicine residencies.

Complementary/Integrative Therapies That Work: A Review of the Evidence.

Significant evidence supports the effectiveness and safety of several complementary or integrative treatment approaches to common primary care problems. Acupuncture is effective in the management of chronic low back pain. Mind-body interventions such as cognitive behavior therapy, yoga, tai chi, qi gong, and music therapy may be helpful for treating insomnia. Exercise can reduce anxiety symptoms. Herbal preparations and nutritional supplements can be useful as first-line therapy for certain conditions, such as fish oil for hypertriglyceridemia, St. John's wort for depression, and Ginkgo biloba extract for dementia, or as adjunctive therapy, such as coenzyme Q10 for heart failure. Probiotic supplementation can significantly reduce the likelihood of antibiotic-associated diarrhea. Physicians should caution patients about interactions, and counsel them about the quality and safety of herbal and nutritional supplements.

Increasing resident recruitment into family medicine: effect of a unique curriculum in integrative medicine.

INTRODUCTION: Healthcare reform is highlighting the need for more family practice and other primary care physicians. The Integrative Medicine in Residency (IMR) curriculum project helped family medicine residencies pilot a new, online curriculum promoting prevention, patient-centered care competencies, use of complementary and alternative medicine along with conventional medicine for management of chronic illness. A major potential benefit of the IMR program is enhanced recruitment into participating residencies, which is reported here. METHODS: Using an online questionnaire, accepted applicants to the eight IMR pilot programs (n = 152) and four control programs (n = 50) were asked about their interests in learning integrative medicine (IM) and in the pilot sites how the presence of the IMR curriculum affected their ranking decisions. RESULTS: Of residents at the IMR sites, 46.7% reported that the presence of the IMR was very important or important in their ranking decision. The IMR also ranked fourth overall in importance of ranking after geography, quality of faculty, and academic reputation of the residency. The majority of IMR residents (87.5%) had high to moderate interest in learning IM during their residency; control residents also had a high interest in learning IM (61.2%). CONCLUSIONS: The presence of the IMR curriculum was seen as a strong positive by applicants in ranking residencies. Increasing the adoption of innovative IM curricula, such as the IMR, by residency programs may be helpful in increasing applications of competitive medical students into primary care residencies as well as in responding to the expressed interest in learning the IM approach to patient care.

Integrative medicine in residency education: developing competency through online curriculum training.

INTRODUCTION: The Integrative Medicine in Residency (IMR) program, a 200-hour Internet-based, collaborative educational initiative was implemented in 8 family medicine residency programs and has shown a potential to serve as a national model for incorporating training in integrative/complementary/alternative medicine in graduate medical education. INTERVENTION: The curriculum content was designed based on a needs assessment and a set of competencies for graduate medical education developed following the Accreditation Council for Graduate Medical Education outcome project guidelines. The content was delivered through distributed online learning and included onsite activities. A modular format allowed for a flexible implementation in different residency settings. EVALUATION: TO ASSESS THE FEASIBILITY OF IMPLEMENTING THE CURRICULUM, A MULTIMODAL EVALUATION WAS UTILIZED, INCLUDING: (1) residents' evaluation of the curriculum; (2) residents' competencies evaluation through medical knowledge testing, self-assessment, direct observations, and reflections; and (3) residents' wellness and well-being through behavioral assessments. RESULTS: The class of 2011 (n  =  61) had a high rate of curriculum completion in the first and second year (98.7% and 84.2%) and course evaluations on meeting objectives, clinical utility, and functioning of the technology were highly rated. There was a statistically significant improvement in medical knowledge test scores for questions aligned with content for both the PGY-1 and PGY-2 courses. CONCLUSIONS: The IMR program is an advance in the national effort to make training in integrative medicine available to physicians on a broad scale and is a success in terms of online education. Evaluation suggests that this program is feasible for implementation and acceptable to residents despite the many pressures of residency.

Integrative medicine approach to chronic pain.

Chronic pain can be a frustrating condition for patient and clinician. The integrative medicine approach to pain can offer hope, adding safe complementary and alternative medical (CAM) therapies to mitigate pain and suffering. Such CAM therapies include nutrition, supplements and herbs, manual medicine, acupuncture, yoga, and mind-body approaches. The evidence is heterogeneous regarding these approaches, but some evidence suggests efficacy and confirms safety. The integrative medicine approach can be beneficial in a patient with chronic pain.