Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

Does engagement matter? The impact of patient and community engagement on implementation of cardiovascular health materials in primary care settings.

BACKGROUND: Engaging patients and community members in healthcare implementation, research and evaluation has become more popular over the past two decades. Despite the growing interest in patient engagement, there is scant evidence of its impact and importance. Boot Camp Translation (BCT) is one evidence-based method of engaging communities in research. The purpose of this report is to describe the uptake by primary care practices of cardiovascular disease prevention materials produced through four different local community engagement efforts using BCT. METHODS: EvidenceNOW Southwest (ENSW) was a randomized trial to increase cardiovascular disease (CVD) prevention in primary care practices. Because of its study design, Four BCTs were conducted, and the materials created were made available to participating practices in the "enhanced" study arm. As a result, ENSW offered one of the first opportunities to explore the impact of the BCT method by describing the uptake by primary care practices of health messages and materials created locally using the BCT process. Analysis compared uptake of locally translated BCT products vs. all other products among practices based on geography, type of practice, and local BCT. RESULTS: Within the enhanced arm of the study that included BCT, 69 urban and 13 rural practices participated with 9 being federally qualified community health centers, 14 hospital owned and 59 clinician owned. Sixty-three practices had 5 or fewer clinicians. Two hundred and ten separate orders for materials were placed by 43 of the 82 practices. While practices ordered a wide variety of BCT products, they were more likely to order materials developed by their local BCT. CONCLUSIONS: In this study, patients and community members generated common and unique messages and materials for cardiovascular disease prevention relevant to their regional and community culture. Primary care practices preferred the materials created in their region. The greater uptake of locally created materials over non-local materials supports the use of patient engagement methods such as BCT to increase the implementation and delivery of guideline-based care. Yes, patient and community engagement matters. TRIAL REGISTRATION AND IRB: Trial registration was prospectively registered on July 31, 2015 at ClinicalTrials.gov (NCT02515578, protocol identifier 15-0403). The project was approved by the Colorado Multiple Institutional Review Board and the University of New Mexico Human Research Protections Office.

A virtual recruitment protocol promotes enrollment of underrepresented groups in a diabetes prevention trial.

Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29-3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups.

A randomized, parallel group, pragmatic comparative-effectiveness trial comparing medication-assisted treatment induction methods in primary care practices: The HOMER study protocol.

Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

PURPOSE: To describe the characteristics of patients and practice of clinicians during standard-of-care for weight management in a large, multiclinic health system before the implementation of PATHWEIGH, a pragmatic weight management intervention. METHODS: We analyzed baseline characteristics of patients, clinicians, and clinics during standard-of-care for weight management before the implementation of PATHWEIGH, which will be evaluated for effectiveness and implementation in primary care using an effectiveness-implementation hybrid type-1 cluster randomized stepped-wedge clinical trial design. A total of 57 primary care clinics were enrolled and randomized to 3 sequences. Patients included in the analysis met the eligibility requirements of age ≥18 years and body mass index (BMI) ≥25 kg/m2 and had a weight-prioritized visit (defined a priori) during the period March 17, 2020 to March 16, 2021. RESULTS: A total of 12% of patients aged ≥18 years and with a BMI ≥25 kg/m2 seen in the 57 practices during the baseline period (n = 20,383) had a weight-prioritized visit. The 3 randomization sequences of 20, 18, and 19 sites were similar, with an overall mean patient age of 52 (SD 16) years, 58% women, 76% non-Hispanic White patients, 64% with commercial insurance, and with a mean BMI of 37 (SD 7) kg/m2. Documented referral for anything weight related was low (<6%), and 334 prescriptions of an antiobesity drug were noted. CONCLUSIONS: Of patients aged ≥18 years and with a BMI ≥25 kg/m2 in a large health system, 12% had a weight-prioritized visit during the baseline period. Despite most patients being commercially insured, referral to any weight-related service or prescription of antiobesity drug was uncommon. These results fortify the rationale for trying to improve weight management in primary care.

Implementation strategies preferred by primary care clinicians to facilitate cancer prevention and control activities.

Key clinical and community members need to be involved in the identification of feasible and impactful implementation strategies for translation of evidence-based interventions into practice. While a wide range of implementation strategies has been developed, there is little research on their applicability for cancer prevention and control (CPC) efforts in primary care. We conducted a survey of primary care physicians to identify implementation strategies they perceive as most feasible and impactful. The survey included both primary prevention behavior change counseling and cancer screening issues. Analyses contrasted ratings of feasibility and impact of nine implementation strategies, and among clinicians in different settings with a focus on comparisons between clinicians in rural vs. non-rural settings. We recruited a convenience sample of 326 respondents from a wide range of practice types from four practice-based research networks in 49 states and including 177 clinicians in rural settings. Ratings of impact were somewhat higher than those for feasibility. Few of the nine implementation strategies were high on both impact and feasibility. Only 'adapting to my practice' was rated higher than a 4 ("moderate") on both impact and feasibility. There were relatively few differences between rural and non-rural clinicians or associated with other clinician or setting characteristics. There is considerable variability in perceived impact and feasibility of implementation strategies for CPC activities among family medicine clinicians. It is important to assess both feasibility and impact of implementation strategies as well as their generalizability across settings. Our results suggest that optimal strategies to implement evidence-based CPC activities will likely need to be adapted for primary care settings. Future research is needed to replicate these findings and identify practical, implementation partner informed implementation strategies.

Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

An Assessment of Weight Loss Management in Health System Primary Care Practices.

BACKGROUND: Primary care practices can help patients address obesity through weight loss; however, there are many barriers to doing so. This study examined weight management services provided and factors associated with higher reported provision of services. METHODS: A survey was given to practice members in 18 primary care practices in a Colorado-based health system. The survey assessed weight management services to determine the amount and type of weight loss assistance provided and other factors that may be important. We used descriptive statistics to summarize responses and linear regression with generalized estimating equations to assess the association between the practice and practice member characteristics and the amount of weight management services provided. RESULTS: The overall response rate was 64% (254/399). On average, clinicians reported performing 73% of the services, and when grouped into minimal, basic, and extensive, the clinicians on average performed 87%, 68%, and 69% of them, respectively. In a multivariable model adjusted for demographics, factors associated with performing more services included perception of overall better practice culture and perception of weight management implementation climate. CONCLUSIONS: Practice-associated factors such as culture and implementation climate may be worth examining to understand how to implement weight management in primary care.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

Context: Despite the fact that obesity is both treatable and preventable, treating the comorbidities, rather than obesity per se remains the mainstay of therapy. Objective: To evaluate the efficacy and implementation of a pragmatic approach to weight management in primary care that prioritizes treatment of weight rather than weight-related diseases (PATHWEIGH). Study Design and Analysis: PATHWEIGH is a hybrid type 1 cluster randomized stepped wedge clinical trial. Clinics were enrolled and randomized to three sequences using covariate constrained randomization. Descriptive statistics were used to summarize clinic and patient characteristics with t-tests, Wilcoxon rank sums or Fisher's exact tests used to compare groups. Setting: Fifty-seven primary care clinics in rural, suburban and urban Colorado in a single healthcare system were utilized. Population Studied: Patients age >18 years and body mass index (BMI) >25 kg/m2 who had a weight-prioritized visit (WPV) in the prior year were enrolled. A WPV was defined as a chief complaint or reason for visit that included "weight", ICD-10 codes for weight or use of an intake questionnaire for weight. Intervention: None. This abstract describes the baseline (pre-intervention) characteristics of the clinics and patients treated with standard-of-care (SOC) for weight management. Outcome Measures: Baseline characteristics of the clinics and patients undergoing a WPV from March 17, 2020 - March 16, 2021. Results: 20,410 patients met these eligibility requirements representing 12% of patients >18 years and body mass index (BMI) >25 kg/m2 seen at the clinic during this baseline period. The three randomization sequences of 20, 18, and 19 sites were similar with an overall median age of 53 years (IQR: 39-65), 58% women, 76% non-Hispanic whites, 64% commercial insurance, and median BMI of 36 kg/m2 (IQR: 32-41). No sequence differences were seen for vital signs, relevant laboratory values, or numbers of comorbidities or medications that cause weight loss or weight gain. Referral for anything weight-related was low (<6%) and only 334 prescriptions of an anti-obesity medication were noted. Conclusions: Of patients >18 years and body mass index (BMI) >25 kg/m2 seen in the 57 primary care clinics, 12% had a weight-prioritized visit during the baseline period. Despite most being commercially insured, referral to any weight-related service or prescription of anti-obesity medication was uncommon.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care.

PURPOSE: Diabetes affects approximately 34 million Americans and many do not achieve glycemic targets. Continuous glucose monitoring (CGM) is associated with improved health outcomes for patients with diabetes. Most adults with diabetes receive care for their diabetes in primary care practices, where uptake of CGM is unclear. METHODS: We used a cross-sectional web-based survey to assess CGM prescribing behaviors and resource needs among primary care clinicians across the United States. We used descriptive statistics and multivariable regression to identify characteristics associated with prescribing behaviors, openness to prescribing CGM, and to understand resources needed to support use of CGM in primary care. RESULTS: Clinicians located more than 40 miles from the nearest endocrinologist's office were more likely to have prescribed CGM and reported greater likelihood to prescribe CGM in the future than those located within 10 miles of an endocrinologist. Clinicians who served more Medicare patients reported favorable attitudes toward future prescribing and higher confidence using CGM to manage diabetes than clinicians with lower Medicare patient volume. The most-needed resources to support CGM use in primary care were consultation on insurance issues and CGM training. CONCLUSIONS: Primary care clinicians are interested in using CGM for patients with diabetes, but many lack the resources to implement use of this diabetes technology. Use of CGM can be supported with education in the form of workshops and consultation on insurance issues targeted toward residents, recent graduates, and practices without a nearby endocrinologist. Continued expansion of Medicare and Medicaid coverage for CGM can also support CGM use in primary care.

Priorities for improvement across cancer and non-cancer related preventive services among rural and non-rural clinicians.

INTRODUCTION: It is not realistic for most clinicians to perform the multitude of recommended preventive primary care services. This is especially true in low resource and rural settings, creating challenges to delivering high-quality care. This study collected stakeholder input from clinicians on which services they most need to improve. METHODS: The authors conducted a survey of primary care physicians 9-12/2021, with an emphasis on rural practices, to assess areas in which clinicians felt the greatest needs for improvement. The survey focused on primary prevention (behavior change counseling) and cancer screening, and contrasted needs for improvement for these services vs. other types of screening, and between clinicians in rural vs. non-rural practices. RESULTS: There were 326 respondents from 4 different practice-based research networks, a wide range of practice types, 49 states and included 177 clinicians in rural settings. Respondents rated the need to improve delivery of primary prevention counseling services highest, with needs for nutrition and dietary assessment and counseling rated highest followed by physical activity and with almost no differences between rural and nonrural. Needs for improvement in cancer screenings were rated higher than non-cancer screenings, except for blood pressure screening. CONCLUSIONS: Both rural and nonrural primary care clinicians feel a need for improvement, especially with primary prevention activities. Although future research is needed to replicate these findings with different populations and other types of preventive service activities, greater priority should be given to development of practical, stakeholder informed assistance and resources for primary care to conduct primary prevention.

Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.

PURPOSE: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT.

Increasing Capacity for Treatment of Opioid Use Disorder in Rural Primary Care Practices.

PURPOSE: Evidence supports treatment for opioid use disorder (OUD) with buprenorphine in primary care practices (PCPs). Barriers that slow implementation of this treatment include inadequately trained staff. This study aimed to increase the number of rural PCPs providing OUD treatment with buprenorphine. This evaluation describes the impact of a practice team training on the implementation and delivery of OUD treatment with buprenorphine in PCPs of rural Colorado. METHODS: Implementing Technology and Medication Assisted Treatment Team Training in Rural Colorado (IT MATTTRs) was a multilevel implementation study that included a practice-focused intervention to improve awareness, adoption, and use of buprenorphine treatment for OUD. Participating PCP teams received the IT MATTTRs Practice Team Training and support. Practices' implementation of treatment components was assessed before and after training. Practice-reported and population-level data from the Prescription Drug Monitoring Program were obtained to describe changes in delivery of treatment after training. RESULTS: Forty-two practices received team training. Practices reported an average of 4.7 treatment-related components in place at baseline compared with 13.0 at 12-month follow-up (F[2,56] = 31.17, P <.001). The proportion of participating practices providing or referring patients for treatment increased from 18.8% to 74.4%. The increase in number of people with a prescription for buprenorphine was significantly greater in the study region over a 4-year period compared with the rest of the state (Wald χ2 = 15.73, P <.001). CONCLUSIONS: The IT MATTTRs training for PCP teams in OUD treatment with buprenorphine addressed elements beyond clinician waiver training to make implementation feasible and effectively increased implementation and delivery of this treatment in rural Colorado.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. METHODS: A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. DISCUSSION: The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678752 . Registered on December 21, 2020.

Does a Rural Community-Based Intervention Improve Knowledge and Attitudes of Opioid Use Disorder and Medication-Assisted Treatment? A Report From the IT MATTTRs Study.

PURPOSE: Understanding knowledge of and attitudes toward medication-assisted treatment (MAT) for opioid use disorder (OUD) is important to changing the conversation about this devastating public health problem. While several studies report clinician knowledge and attitudes and training, less is known about community member perspectives. As part of the Implementing Technology and Medication Assisted Treatment Team Training in Rural Colorado study (IT MATTTRs), this study describes the implementation of community-based interventions developed by rural community members and researchers to increase awareness and promote positive attitudes toward MAT for OUD and explores changes in community members' OUD and MAT knowledge and beliefs. METHODS: Using the Boot Camp Translation process, the High Plains Research Network and Colorado Research Network MAT Advisory Councils developed multicomponent interventions on MAT for OUD. Baseline and postintervention surveys were administered using venue-based sampling of community members in rural communities. FINDINGS: Surveys were completed by 789 community members at baseline and 798 at postintervention. Nearly half (49%) reported exposure to at least 1 intervention product. Greater exposure to intervention materials was associated with beliefs that using opioids to get high in rural communities is a problem (P < .0001), that opioid addiction is a chronic disease (P = .0032), and that OUD can be treated locally (P = .0003). CONCLUSIONS: Partnering with local community members resulted in the successful development and implementation of community-based interventions, exposure to which was associated with OUD knowledge and beliefs. Locally created interventions should be included in comprehensive approaches to stem the OUD epidemic.

Relationship of primary care clinician characteristics with continuous glucose monitoring use and confidence.

Context: Continuous glucose monitoring (CGM) provides clearer readings of blood glucose levels than traditional finger-stick glucose tests and is associated with improved diabetes outcomes such as reduced HbA1c. CGM can inform insulin dosing and diet decisions, and alert patients to hypoglycemia. A lack of endocrinologists in the majority of U.S. counties, particularly rural areas, and long wait times in many endocrinologists' offices create disparities in CGM access for patients with diabetes. Expanding use of CGM in primary care can improve care and patient diabetes outcomes. Objective: Understand primary care clinicians' experience with CGM to determine feasibility and resources needed to prescribe CGM. Study Design: Quantitative phase of explanatory sequential mixed methods study using cross-sectional online survey. Setting: Primary care. Population studied: Primary care physicians and advanced practice providers across the U.S. Outcome Measures: Past CGM prescribing behaviors, future likelihood to prescribe, resources needed to prescribe. Results: 632 respondents. Role: 72% attending physicians. Organization: Federally Qualified Health-Center (or similar) (27%), hospital-owned (27%), private practice (22%). Half (47%) had seen patients with CGM but never prescribed; two-fifths (39%) had prescribed CGM. Three-fifths (62%) moderately or very likely to prescribe CGM in the future. Likelihood to have prescribed CGM: Post-training physicians more likely than residents (OR=0.303, CI=.160-.575) or PA/NPs (OR=0.356, CI=.165-.766), part-time practice less likely than full-time (OR=0.546, CI=.305-.978), <75% time delivering primary care less likely than 75%+ (OR=0.595, CI=.371-.955), and location greater than 40 miles from an endocrinologist more likely than endocrinologist within 10 miles (OR=1.941, CI=1.17-3.21). Likelihood to prescribe with access to various resources greatest for consultation on insurance issues (72% moderately/very likely) and CGM education/training (72% moderately/very likely). Conclusions: Primary care clinicians have interest in prescribing CGM for patients with diabetes. Clinician type, percentage of time spent practicing, portion of time delivering primary care, and distance from endocrinologist are related to likelihood to prescribe CGM. Previous experience prescribing CGM may improve confidence and likelihood of future prescribing. Consultation, education and training on CGM for primary care clinicians may increase access to CGM.

Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial.

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions. Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race. Design, Setting, and Participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis. Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values. Main Outcomes and Measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured. Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]). Conclusions and Relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03028597.

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

Bikes for Life: Measuring the effects of a bicycle distribution program on 6 to 12-year-old children's BMI and health behaviors.

Treating pediatric obesity is challenging. The objective was to evaluate effect of receiving a bicycle on (a) physical activity, (b) sedentary activity, (c) Body Mass Index (BMI), and (d) eating habits. A stepped-wedge randomized controlled trial of 6- to 12-year-old patients with overweight/obesity was conducted April 2012-2018. Participants were randomized to wait 0, 2, 4, or 6 months for a bicycle. Outcomes on activity, BMI and eating were collected at 3, 6, 9- and 12-months after children received a bicycle. A total of 525 participants with 387 (74%) completed 3-month follow-up questionnaire, and 346 (66%) completed 12-month follow-up visit. Participants were mostly Latino/a (71%) and low income (58%), and 31% had never ridden a bicycle. Median baseline BMI was 98th percentile. At 3 months, 62% reported bicycle use last week, on average 3.6 days. Time spent on sedentary activities decreased by 48 min/day (p = 0.04), and time spent playing sports increased by 1.7 h/week (p < 0.01). No reduction in BMI was seen. Consumption of sugary drinks decreased (by 0.59 servings/week, p < 0.01), and consumption of vegetables increased (0.71 servings/week, p = 0.04). At 12 months, sedentary time, sugary drink and vegetable consumption remained significantly more favorable than at enrollment (p < 0.01, p < 0.01, p = 0.04 respectively), but not significantly different (p = 0.47 for sedentary, p = 0.73 for sugary drink) and significantly less favorable (p < 0.01 for vegetables) than at the time of intervention. Participants reported riding bicycle, improved activity and dietary habits, though reversion towards baseline behavior was seen by one year and no change in BMI from enrollment.