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.

Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial.

BACKGROUND/AIMS: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. METHODS: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. RESULTS: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. CONCLUSION: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.

Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: Outcomes of the PRIMIER cohort.

OBJECTIVE: To evaluate the real-world effectiveness of integrative medicine treatment on quality of life using the Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER). DESIGN: A prospective, longitudinal, observational evaluation of patient reported outcomes for quality of life. SETTING: Participants were patients from 17 integrative medicine clinics who received personalized, integrative medicine treatments between August 2013 and October 2017. MAIN OUTCOME MEASURES: Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS)- 29, Perceived Stress Scale-4 (PSS-4), and the Patient Activation Measure (PAM) at index (baseline) visit and at 2, 4, 6, and 12 month follow-up assessments. Electronic health record data included diagnostic and billing codes/descriptions. A linear mixed-effects model was used to test whether outcomes changed from index through 12 months RESULTS: During enrollment, 4883 participants began the assessment, 3658 completed the index measures, and 2374 (65 %) completed at least 1 follow-up assessment, had electronic health record data and at least 1 integrative medicine visit. Most participants (mean age=51.4 years) were white (88.4 %), female (79.7 %), and college-educated (78.5 %). Significant improvements (p < 0.001) were observed at 12-months on all PROMIS-29 measures, PSS-4, and PAM. At 12 months, clinically meaningful improvements were found for 38 % and 28 % on PROMIS-29 Mental and Physical Health Summary scores respectively. CONCLUSIONS: PRIMIER is the largest study to assess the real-world effectiveness of integrative medicine. Results indicate a statistical and clinical improvement across all measures at 12 months. Future research could explore whether dosing, timing or combinations of integrative medicine interventions have differential impacts on quality of life.

Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial.

BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.

Treatment for hepatitis C virus with direct acting antiviral agents: Perspectives and treatment experiences of people who inject drugs.

INTRODUCTION: Increasingly, people who inject drugs (PWID) infected with hepatitis C virus (HCV) are gaining access to highly effective direct-acting antiviral agents (DAAs). Although past studies examined patient experiences with interferon-based treatments, few have explored patient experiences with these new generation therapeutics. Research and real world experience indicate that many PWID can be successfully treated with the new DAAs. Yet a substantial minority fail to complete treatment or achieve only suboptimal adherence. This qualitative study examines experiences with treatment among participants in Project HERO, a large multisite trial designed to compare treatment delivery methods for DAAs. We explored treatment experiences among HERO participants, with the goal of understanding potential barriers to treatment engagement and completion. METHODS: We conducted qualitative interviews with a sample of 21 participants, including 14 who completed HCV treatment and 7 participants who discontinued treatment before the end of the 12-week medication course. The first phase of the analysis was descriptive, examining participants' life experiences, histories of disease and treatment seeking, experiences with the program, and barriers to treatment completion. The second phase of the analysis examined differences between completers and noncompleters. RESULTS: Participants offered a variety of reasons for seeking treatment. Both groups of participants reported highly positive experiences of the HERO trial. Participants described research staff as caring, respectful, and nonjudgmental. Substance use was reported by both groups, yet completers described "manageable" substance use, while noncompleters described substance use that sapped their energy and motivation. Shame over drug use was a barrier to treatment completion. Homelessness and a reported lack of social support were much more common in the noncompleter group. CONCLUSIONS: Reasons for noncompletion were not related to features of the clinical trial or treatment program. Our results indicate the importance of: 1) recognizing and addressing severe social and economic challenges such as homelessness; and 2) building a program culture of respect and compassion in treatment programs for PWID infected with HCV.

Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.

PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Differences in complications, cardiovascular risk factor, and diabetes management among participants enrolled at veterans affairs (VA) and non-VA medical centers in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE).

AIMS: We evaluated differences in participants with type 2 diabetes (T2DM) enrolled in the GRADE study at VA vs non-VA sites, focusing on cardiovascular risk factors and rates of diabetes care target achievements. METHODS: We compared baseline characteristics between participants at VA (n = 1216) and non-VA (n = 3831) sites, stratifying analyses by cardiovascular disease (CVD) history. RESULTS: VA and non-VA participants had similar diabetes duration (4.0 years), HbA1c (7.5%), and BMI (34 kg/m2); however, VA participants had more individuals ≥ 65 years (37.3% vs 19.8%, p < 0.001), men (90.0% vs 55.2%, p < 0.001), hypertension (75.8% vs 63.6%, p < 0.001), hyperlipidemia (76.6% vs 64.6%, p < 0.001), current smokers (19.0% vs 12.1%, p < 0.001), nephropathy (20.4% vs 17.0%, p < 0.05), albuminuria (18.4% vs 15.1%, p < 0.05), and CVD (10.4% vs 5.2%, p < 0.001). In those without CVD, more VA participants were treated with lipid (70.8% vs 59.5%, p < 0.001) and blood pressure (74.9% vs 65.4%, p < 0.001) lowering medications, and had LDL-C < 70 mg/dl (32.9% vs 24.2%, p < 0.05). Among those with CVD, more VA participants had BP < 140/90 (80.2% vs 70.1%, p < 0.05) after adjusting for demographics. CONCLUSION: GRADE participants at VA sites had more T2DM complications, greater CVD risk and were more likely to be treated with medications to reduce it, leading to more LDL-C at goal than non-VA participants, highlighting differences in diabetes populations and care.

Facilitators and barriers to post-discharge pain assessment and triage: a qualitative study of nurses' and patients' perspectives.

BACKGROUND: After hospital discharge, patients can experience symptoms prompting them to seek acute medical attention. Early evaluation of patients' post-discharge symptoms by healthcare providers may improve appropriate healthcare utilization and patient safety. Post-discharge follow-up phone calls, which are used for routine transitional care in U.S. hospitals, serve as an important channel for provider-patient communication about symptoms. This study aimed to assess the facilitators and barriers to evaluating and triaging pain symptoms in cardiovascular patients through follow-up phone calls after their discharge from a large healthcare system in Central Massachusetts. We also discuss strategies that may help address the identified barriers. METHODS: Guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), we completed semi-structured interviews with 7 nurses and 16 patients in 2020. Selected nurses conducted (or supervised) post-discharge follow-up calls on behalf of 5 clinical teams (2 primary care; 3 cardiology). We used thematic analysis to identify themes from interviews and mapped them to the domains of the PRISM model. RESULTS: Participants described common facilitators and barriers related to the four domains of PRISM: Intervention (I), Recipients (R), Implementation and Sustainability Infrastructure (ISI), and External Environment (EE). Facilitators include: (1) patients being willing to receive provider follow-up (R); (2) nurses experienced in symptom assessment (R); (3) good care coordination within individual clinical teams (R); (4) electronic health record system and call templates to support follow-up calls (ISI); and (5) national and institutional policies to support post-discharge follow-up (EE). Barriers include: (1) limitations of conducting symptom assessment by provider-initiated follow-up calls (I); (2) difficulty connecting patients and providers in a timely manner (R); (3) suboptimal coordination for transitional care among primary care and cardiology providers (R); and (4) lack of emphasis on post-discharge follow-up call reimbursement among cardiology clinics (EE). Specific barriers for pain assessment include: (1) concerns with pain medication misuse (R); and (2) no standardized pain assessment and triage protocol (ISI). CONCLUSIONS: Strategies to empower patients, facilitate timely patient-provider communication, and support care coordination regarding pain evaluation and treatment may reduce the barriers and improve processes and outcomes of pain assessment and triage.

Barriers to Prevention and Timely Presentation of Diabetic Foot Ulcers: Perspectives of Patients from a High-risk Urban Population in the United States.

Diabetic foot amputation is a preventable complication that is increasing in incidence in the United States, with disparities across geography, race, ethnicity, and income. This qualitative study explored the experiences of people in a low-income urban area in the United States in preventing and obtaining care for foot ulcers. Sixteen adults with foot ulcers were identified through purposive sampling based on records of hospital stays and primary care visits. Semi-structured interviews were transcribed and analyzed for key themes. Participants described inadequate understanding of diabetic foot disease: many sought care only after developing advanced symptoms. They identified social and health system factors as barriers to timely access to care. Some participants described a realization of the seriousness of their condition and an ability to improve self-care after developing an ulcer. Patients' experiences can inform the design of amputation-reduction initiatives to achieve more desirable results, including enhanced self-management capabilities, timely access, and attention to social determinants.

Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial.

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites). RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8). In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts. TRIAL REGISTRATION ClinicalTrials.govNCT01911208.

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.

NExUS-Heart: Novel examinations using smart technologies for heart health-Data sharing from commercial wearable devices and telehealth engagement in participants with or at risk of atrial fibrillation.

Background: Telemedicine and commercial wearable devices capable of detecting atrial fibrillation (AF) have revolutionized arrhythmia care during coronavirus disease 2019. However, not much is known about virtual patient-provider interactions or device sharing behaviors. Objective: The purpose of this study was to characterize how participants with or at risk of AF are engaging with their providers in the context of telemedicine and using commercially wearable devices to manage their health. Methods: We developed a survey to describe participant behaviors around telemedicine encounters and commercial wearable device use. The survey was distributed to participants diagnosed with AF or those at risk of AF (as determined by being at least 65 years old and having a CHA2DS2-VASc stroke risk score of >2) in the University of Massachusetts Memorial Health Care system. Results: The survey was distributed to 23,530 patients, and there were 1222 (5.19%) participant responses. Among the participants, 327 (26.8%) had AF and 895 (73.2%) were at risk of AF. Neither device ownership nor device type use differed by AF status. After adjusting for covariates that may influence surveyed participant communication patterns, we found that participants with AF were more likely to share their wearable device-derived data with providers (adjusted odds ratio 1.87; 95% confidence interval 1.02-3.41). Rates of sharing physical activity or sleep data were low for both groups and did not differ by AF status. Conclusion: Compared with participants at risk of developing AF, those with AF were more likely to share heart rate and rhythm data from their commercial wearable devices with providers. However, both groups had similar rates of sharing physical activity and sleep data, telemedicine engagement, and technology use and ownership.

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

BACKGROUND: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

"Not Alone Anymore": The Experiences of Adults With Diabetes in New York's Medicaid Health Home Program.

BACKGROUND: New York State Medicaid's Health Home program is an example of a natural experiment that could affect individuals with diabetes. While evaluations of interventions such as the Health Home program are generally based solely on clinical and administrative data and rarely examine patients' experience, patients may add to the understanding of the intervention's implementation and mechanisms of impact. OBJECTIVE: The objective of this study was to qualitatively examine the health and nonmedical challenges faced by Medicaid-insured patients with diabetes and their experiences with the services provided by New York's Health Homes to address these challenges. RESEARCH DESIGN: We performed 10 focus groups and 23 individual interviews using a guide developed in collaboration with a stakeholder board. We performed a thematic analysis to identify cross-cutting themes. SUBJECTS: A total of 63 Medicaid-insured individuals with diabetes, 31 of whom were enrolled in New York's Health Home program. RESULTS: While participants were not generally familiar with the term "Health Home," they described and appreciated services consistent with Health Home enrollment delivered by care managers. Services addressed challenges in access to care, especially by facilitating and reminding participants about appointments, and nonmedical needs, such as transportation, housing, and help at home. Participants valued their personal relationships with care managers and the psychosocial support they provided. CONCLUSIONS: From the perspective of its enrollees, the Health Home program primarily addressed access to care, but also addressed material and psychosocial needs. These findings have implications for Health Home entities and for research assessing their impact.

Individual vs. Group Delivery of Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary Care-a Randomized Trial.

BACKGROUND: Acupuncture has been shown to be effective for the treatment of chronic musculoskeletal back, neck, and osteoarthritis pain. However, access to acupuncture treatment has been limited in medically underserved and low-income populations. OBJECTIVE: Acupuncture therapy delivered in groups could reduce cost and expand access. We compared the effectiveness of group versus individual acupuncture for pain and function among ethnically diverse, low-income primary care patients with chronic musculoskeletal pain. DESIGN: This was a randomized comparative effectiveness non-inferiority trial in 6 Bronx primary care community health centers. Participants with chronic (> 3 months) back, neck, or osteoarthritis pain were randomly assigned to individual or group acupuncture therapy for 12 weeks. PARTICIPANTS: Seven hundred seventy-nine participants were randomized. Mean age was 54.8 years. 35.3% of participants identified as black and 56.9% identified as Latino. Seventy-six percent were Medicaid insured, 60% reported poor/fair health, and 37% were unable to work due to disability. INTERVENTIONS: Participants received weekly acupuncture treatment in either group or individual setting for 12 weeks. MAIN MEASURES: Primary outcome was pain interference on the Brief Pain Inventory at 12 weeks; secondary outcomes were pain severity (BPI), physical and mental well-being (PROMIS-10), and opiate use. Outcome measures were collected at baseline, 12 and 24 weeks. KEY RESULTS: 37.5% of individual arm and 30.3% in group had > 30% improvement in pain interference (d = 7.2%, 95% CI - 0.6%, 15.1%). Non-inferiority of group acupuncture was not demonstrated for the primary outcome assuming a margin of 10%. In the responder analysis of physical well-being, 63.1% of individual participants and 59.5% of group had clinically important improvement at 12 weeks (d = 3.6%, 95% CI - 4.2%, 11.4%). CONCLUSIONS: Both individual and group acupuncture therapy delivered in primary care settings reduced chronic pain and improved physical function at 12 weeks; non-inferiority of group was not shown. TRIAL REGISTRATION: Clinicaltrials.gov # NCT02456727.

Assessing the association of depression and anxiety with symptom reporting among individuals with type 2 diabetes.

Depression and anxiety have been linked to increased somatic symptoms among individuals with type 2 diabetes (T2D), but their independent effects and role in symptom attributions remain unclear. This study examined depression and anxiety in relation to total symptoms and symptom attributions in a diverse sample of 120 adults with T2D. Multiple linear regression tested associations after controlling for medical comorbidities and insulin use. Clinician-rated depression (ß = .53, p < .001), self-reported depression (ß = .59, p < .001) and self-reported anxiety (ß = .62, p < .001) were positively associated with total somatic symptoms. Models adjusting for depression and anxiety revealed significant independent effects for each, regardless of measurement method. In attribution models, only self-reported depression (ß = .27, p = .003) was significantly associated with greater attribution to diabetes, whereas clinician-rated depression (ß = .19, p = .047), self-reported depression (ß = .38, p < .001) and anxiety (ß = .28, p = .004) were associated with increased attribution to medications. In models adjusting for depression and anxiety, self-reported depression was a significant independent predictor of diabetes (ß = .29, p = .023) and medication (ß = .38, p = .004) attribution; anxiety was a significant predictor of medication attribution (ß = .25, p = .039). Findings suggest depression and anxiety are implicated in overall increases in somatic symptom complaints and an increased tendency to attribute these symptoms to diabetes and side-effects of diabetes medications among adults with T2D.

Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: a qualitative study.

Background: Recruitment of participants into research studies, especially individuals from minority groups, is challenging; lack of diversity may lead to biased findings. Aim: To explore beliefs about research participation among individuals who were approached and eligible for the GRADE study. Methods: In-depth qualitative telephone interviews with randomized participants (n = 25) and eligible individuals who declined to enroll (n = 26). Results: Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation. Few participants understood how comparative effectiveness research differed from other types of trials; however, some features of comparative effectiveness research were perceived as lower risk. Conclusion: We identified facilitators and addressable barriers to participation in research studies.

Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study.

INTRODUCTION: Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC). METHOD: We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes. CONCLUSION: If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.