The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes.

BACKGROUND: Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes. METHODS/DESIGN: The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS). CONCLUSIONS: This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.

Safety of SGLT2 inhibitors, DPP-4 inhibitors, and GLP-1 receptor agonists in US veterans with and without chronic kidney disease: a population-based study.

Background: We examined the real-world comparative safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i) vs. other newer anti-glycemic medications (dipeptidyl peptidase-4 inhibitors [DPP4i], glucagon-like peptide-1 receptor agonists [GLP1a]) in patients with and without chronic kidney disease (CKD). Methods: Among US Veterans with diabetes receiving care from the Veterans Affairs (VA) healthcare system over 2004-19, we identified incident users of SGLT2i vs. DPP4i vs. GLP1a monotherapy. In analyses stratified by CKD status, defined by estimated glomerular filtration rate and albuminuria, we examined associations of SGLT2i vs. DPP4i vs. GLP1a use with risk of infection-related (primary outcome) and genitourinary infection hospitalizations (secondary outcome) using multivariable Cox models. Findings: Among 92,269 patients who met eligibility criteria, 52% did not have CKD, whereas 48% had CKD. In the overall and non-CKD cohorts, compared to DPP4i use, SGLT2i use was associated with lower infection-related hospitalization risk (HRs [95% CIs] 0.74 [0.67-0.81] and 0.77 [0.67, 0.88], respectively), whereas GLP1a use demonstrated comparable risk. However, in the CKD cohort SGLT2i and GLP1a use were each associated with lower risk (HRs [95% CIs] 0.70 [0.61, 0.81] and 0.91 [0.84, 0.99], respectively). Propensity score-matched analyses showed similar findings in the non-CKD and CKD cohorts. In the overall, non-CKD, and CKD cohorts, SGLT2i use was associated with lower genitourinary infection hospitalization risk whereas GLP1a use showed comparable risk vs. DPP4i use. Interpretation: In a national cohort of Veterans with diabetes, compared with DPP4i use, SGLT2i use was associated with lower infection-related and genitourinary infection hospitalization risk. Funding: VA Health Services Research and Development, USA.

Incident Diuretic Use and Subsequent Risk of Bone Fractures: A Large Nationwide Observational Study of US Veterans.

OBJECTIVE: To investigate the association of incident use of diuretics with subsequent risk of incident bone fractures. PATIENTS AND METHODS: In a nationwide cohort of 863,339 US veterans receiving care from the VA health care system between October 1, 2004, and September 30, 2006, with follow-up through June 30, 2018, we examined the association of incident diuretic use (overall, and separately by thiazide, loop, and potassium-sparing diuretics) with subsequent risk of incident bone fractures using multivariable Cox regression models while minimizing confounding by indication using a target trial emulation approach. RESULTS: Patients were 63.3±12.9 years old; 93.5% (n=807,180) were male; and 27.1% (n=233,996) were diabetic. Their baseline estimated glomerular filtration rate was 84.4±16.5 mL/min per 1.73 m2. Among 863,339 patients, 424,386 (49.2%) newly initiated diuretics, of which 77.4% (n=328,524), 22.5% (n=95,457), and 0.1% (n=405) were thiazide, loop, and potassium-sparing diuretic users, respectively. After multivariable adjustments, incident diuretic use (vs non-use) was significantly associated with higher risk of incident fracture (adjusted HR [aHR], 1.14; 95% CI, 1.11 to 1.16). The association was most pronounced for loop diuretics (aHR, 1.39; 95% CI, 1.35 to 1.44) but less evident for thiazide diuretics (aHR, 1.08; 95% CI, 1.06 to 1.10) and was not significant for potassium-sparing diuretics (aHR, 0.97; 95% CI, 0.62 to 1.52). The diuretic-fracture association was more evident in younger (vs older) patients, those with (vs without) corticosteroid use, and those with lower (vs higher) serum sodium levels. CONCLUSION: Incident use of diuretics, particularly loop diuretics, was independently associated with higher risk of incident bone fractures. Our findings suggest distinct pathophysiologic contributions of diuretics to bone metabolism and the need for careful attention to skeletal outcomes when initiating diuretics.

Building Statewide Quality Improvement Capacity to Improve Cardiovascular Care and Health Equity: Lessons from the Tennessee Heart Health Network.

DRIVING FORCES: Many states with high rates of cardiovascular disease (CVD) lack statewide quality improvement (QI) infrastructure (for example, resources, leadership, community) to address relevant health needs of the population. Academic health centers are well positioned to play a central role in addressing this deficiency. This article describes early experience and lessons learned in building statewide QI infrastructure through the Tennessee Heart Health Network (Network). APPROACH: A statewide, multistakeholder network composed of primary care practices (PCPs), health systems, health plans, QI organizations, patients, and academic institutions was led by the University of Tennessee Health Science Center (UTHSC), an academic health center, to improve cardiovascular health by supporting dissemination and implementation of patient-centered outcomes research (PCOR) evidence-based interventions in primary care. PCPs were required to select and implement at least one of three interventions (health coaching, tailored health-related text messaging, and pharmacist-physician collaboration). OUTCOMES AND KEY INSIGHTS: Thirty statewide organizational partners joined the Network in year one, including 18 health systems representing 77 PCPs (30.0% of 257 potentially eligible PCPs identified) with approximately 300,000 patients. The organizational partners share EHRs for the ongoing tracking and reporting of key health metrics, including hypertension control and delivery of tobacco cessation counseling. Of the 77 PCPs, 62 continue participation after year two (80.5% retention). Main barriers to participation and reasons for discontinuing participation included reluctance to share data and changes in leadership at the health system level. These 62 PCPs selected the following interventions to implement: health coaching (41.9%), tailored health-related text messages (48.4%), and pharmacist-physician collaboration (40.3%). CONCLUSION AND WHAT'S NEXT: Academic health centers have broad reach and high acceptability by diverse stakeholders. Tennessee's experience illustrates how academic health centers can serve as platforms for building a statewide infrastructure for disseminating, implementing, and sustaining QI interventions at the practice level. Assessment of Network impact is ongoing.

Efficacy Studies of Home-Based Occupational Therapy Services Following Stroke: A Scoping Review.

The aim of this scoping review was to review and assess recent studies on the efficacy of home-based occupational therapy interventions for adults post-stroke. The number of efficacy studies is limited. The few studies available suggest that occupational therapy delivered in home settings may improve outcomes for stroke patients. There is also limited use of occupation-based assessments, interventions, and outcome measures in studies addressing home-based occupational therapy. Methodologies should be improved to include contexts, caregiver training, and self-efficacy. Further high-quality studies are needed on the efficacy home-based occupational therapy services.

Association of oral iron replacement therapy with kidney failure and mortality in CKD patients.

Background: Oral iron is the predominant route of iron replacement (IRT) but its benefits and safety are unclear in patients with chronic kidney disease (CKD). Methods: We examined the association of oral IRT vs no IRT with end-stage kidney disease (ESKD) and mortality in a national cohort of US Veterans. We identified 17 413 incident new users of oral IRT with estimated glomerular filtration rates <60 mL/min/1.73 m2 and 32 530 controls who did not receive any IRT during 2004-18. We used propensity score-overlap weighting to account for differences in key baseline characteristics associated with the use of oral IRT. We examined associations using competing risk regression and Cox models. Results: In the cohort of 49 943 patients, 1616 (3.2%) patients experienced ESKD and 28 711 (57%) patients died during a median follow-up of 1.9 years. Oral IRT was not associated with ESKD [subhazard ratio (HR) (95% confidence interval, CI) 1.00 (0.84-1.19), P = .9] and was associated with higher risk of all-cause mortality [HR (95% CI) 1.06 (1.01-1.11), P = .01]. There was significant heterogeneity of treatment effect for mortality, with oral IRT associated with higher mortality in the subgroups of patients without congestive heart failure (CHF), anemia or iron deficiency. In patient with blood hemoglobin <10 g/dL oral IRT was associated with significantly lower mortality. Conclusion: Oral IRT was associated with lower mortality only in patients with anemia. In patients without anemia, iron deficiency or CHF, the risk-benefit ratio of oral IRT should be further examined.

Association of iron therapy with incidence of chronic kidney disease.

OBJECTIVE: We investigated the association of oral iron replacement with the incidence of chronic kidney disease (CKD) in a population with normal kidney function to study the effects of iron replacement on the development of new onset CKD. METHODS: In a national cohort of US Veterans with no pre-existing CKD, we identified 33 894 incident new users of oral iron replacement and a comparable group of 112 780 patients who did not receive any iron replacement during 2004-2018. We examined the association of oral iron replacement versus no iron replacement with the incidence of eGFR <60 mL/min/1.73 m2 and the incidence of urine albumin creatinine ratio (UACR) ≥30 mg/g in competing risk regressions and in Cox models. We used propensity score weighing to account for differences in key baseline characteristics associated with the use of oral iron replacement. RESULTS: In the cohort of 146 674 patients, a total of 18 547 (13%) patients experienced incident eGFR <60 mL/min/1.73 m2 , and 16 117 patients (11%) experienced new onset UACR ≥30 mg/g. Oral iron replacement was associated with significantly higher risk of incident eGFR <60 mL/min/1.73 m2 (subhazard ratio, 95% confidence interval [CI]: 1.3 [1.22-1.38], p < .001) and incident albuminuria (subhazard ratio, 95% CI: 1.14 [1.07-1.22], p < .001). CONCLUSION: Oral iron replacement is associated with higher risk of new onset CKD. The long-term kidney safety of oral iron replacement should be tested in clinical trials.

Comorbidities and neighborhood factors associated with prescription of sodium-glucose cotransporter protein-2 inhibitors and glucagon-like peptide-1 receptor agonists among medically underserved populations.

BACKGROUND: Evidence from clinical trials shows that newer second-line diabetes medications-glucagon-like peptide 1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is)-have cardio-renal protective effects in addition to their glucose-lowering properties. Despite strong evidence of benefits, there is limited evidence regarding prescribing patterns for these medications, especially among populations at high risk for disparities. OBJECTIVE: To examine the associations of cardio-renal and obesity comorbidities and neighborhood factors with the prescribing of GLP-1RAs or SGLT2is in comparison with dipeptidyl peptidase 4 inhibitors (DPP-4is) or sulfonylureas (SFUs) and for each of the newer second-line diabetes medications (GLP-1RA vs DPP-4i, SGLT2i vs DPP-4i, GLP-1RA vs SFU, and SGLT2i vs SFU) in medically underserved populations. METHODS: A retrospective cohort study was conducted using electronic medical records from a health care delivery system that serves medically underserved populations in the Mid-South region of the United States. Metformin-treated adult patients with type 2 diabetes, and at least 1 prescription for GLP-1RA, SGLT2i, DPP-4i, or SFU class medications, were identified between April 2016 and August 2021. Neighborhood factors were assessed at the census tract level by geocoding and linking patient addresses to neighborhood-level risk factors. Using multilevel logistic regression models, we examined the associations of comorbidities and neighborhood factors with the prescription of newer second-line diabetes medications. RESULTS: 7,723 patients received newer second-line diabetes medications, with 16% prescribed GLP-1RAs, 11% prescribed SGLT2is, 28% prescribed DPP-4is, and 45% prescribed SFUs. Patients with cerebrovascular disease were significantly less likely to receive newer second-line diabetes medications (odds ratio [OR] = 0.65, 95% CI = 0.52-0.80). Patients with obesity were more likely to receive newer second-line diabetes medications (OR = 1.68, 95% CI = 1.48-1.90). Living in neighborhoods with higher proportions of college graduates was associated with a higher likelihood of receiving newer second-line diabetes medications (quartile 3 vs 1: OR = 1.30, 95% CI = 1.06-1.59; and quartile 4 vs 1: OR = 1.46, 95% CI = 1.13-1.88). CONCLUSIONS: Our findings demonstrate substantial underprescribing and significant clinical and neighborhood variations in the use of newer second-line diabetes medications. We found lower use of newer second-line diabetes medications among patients with cerebrovascular disease and higher use in those with obesity. Our findings also suggest that newer second-line diabetes medications are first adopted by those in higher socioeconomic groups, thus increasing disparities in care. DISCLOSURES: Dr Surbhi reports grants or contracts from the Tennessee Department of Health, Agency for Healthcare Research and Quality, and PhRMA Foundation. Dr Bailey reports honoraria from the SouthEast Texas Chapter of the American College of Healthcare Executives, leadership or fiduciary role in the Coalition for Better Health and The Healthy City, Inc., and stock or stock options in Proctor and Gamble, Walmart, and Apple. Dr Kovesdy reports personal fees from Bayer, Abbott, AstraZeneca, Takeda, Tricida, Akebia, Cara Therapeutics, Vifor, Rockwell, CSL Behring, Boehringer Ingelheim, and GSK, outside the submitted work. The other authors report no conflicts of interest.

Racial and Socioeconomic Characteristics Associated with the use of Telehealth Services Among Adults With Ambulatory Sensitive Conditions.

Introduction: The COVID-19 pandemic led to a major transition for patients from routine ambulatory-care-based in-person primary care visits to telehealth visits to manage chronic diseases. However, it remains unclear the extent to which individuals access telehealth services and whether such utilization varies along neighborhood characteristics, especially among racial minorities. This study aims to examine the association of outpatient telehealth utilization with sociodemographic, clinical, and neighborhood characteristics among adults with ambulatory care sensitive conditions (ACSCs) during the COVID-19 pandemic. Methods: We included adults treated for an ACSC between March 5, 2020, and December 31, 2020, at a single ambulatory-care-based healthcare system, which serves a large population of low-income patients in the South region of the United States (i.e., Memphis, TN, Metropolitan Statistical Area). Telehealth utilization was defined by outpatient procedural codes and providers' notes on the type of visits. Generalized linear mixed models were used to examine the association of sociodemographic, clinical, and neighborhood factors with telehealth utilization in the overall cohort and the racial subpopulations. Results: Among the 13,962 adults with ACSCs, 8583 (62.5%) used outpatient telehealth services. Patients who were older, female, with mental disorders, and who had more comorbidities had higher rates of telehealth services (p < .05). Controlling for covariates, we observed 75.2% and 23.1% increased use of telehealth services among Hispanics and other race groups, respectively, compared to Whites. Patients who commuted more than 30 minutes to health facilities were slightly less likely to use telehealth services [OR: 0.994 (0.991,0.998)]. Racial minorities (Blacks and Hispanics) with mental disorders were more likely to use telehealth service when compared to Whites. Discussion: We found that among patients being treated for ACSCs, the use of telehealth services was highly prevalent in Hispanic patients in general and were more pronounced among both Hispanics and Black patients who have mental disorders.

Effect of continuity of care on emergency department and hospital visits for obesity-associated chronic conditions: A federated cohort meta-analysis.

BACKGROUND: Obesity-associated chronic conditions (OCC) are prevalent in medically underserved areas of the Southern US. Continuity of care with a primary care provider is associated with reduced preventable healthcare utilization, yet little is known regarding the impact of continuity of care among populations with OCC. This study aimed to examine whether continuity of care protects patients living with OCC and the subgroup with type 2 diabetes (OCC+T2D) from emergency department (ED) and hospitalizations, and whether these effects are modified by race and patient residence in health professional shortage areas (HPSA) METHODS: We conducted a retrospective federated cohort meta-analysis of 2015-2018 data from four large practice-based research networks in the Southern U.S. among adult patients with obesity and one more more additional diagnosed OCC. The outcomes included overall and preventable ED visits and hospitalizations. Continuity of care was assessed at the clinic-level using the Bice-Boxerman Continuity of Care Index RESULTS: A total of 111,437 patients with OCC and 47,071 patients with OCC+T2D from the four large practice-based research networks in the South were included in the meta-analysis. Continuity of Care index varied among sites from a mean (SD) of 0.6 (0.4) to 0.9 (0.2). Meta-analysis demonstrated that, regardless of race or residence in HPSA, continuity of care significantly protected OCC patients from preventable ED visits (IRR:0.95; CI:0.92-0.98) and protected OCC+T2D patients from overall ED visits (IRR:0.92; CI:0.85-0.99), preventable ED visits (IRR:0.95; CI:0.91-0.99), and overall hospitalizations (IRR:0.96; CI:0.93-0.98) CONCLUSION: Improving continuity of care may reduce ED and hospital use for patients with OCC and particularly those with OCC+T2D.

Feasibility of a Brief Intervention to Increase Rapid Primary Care Follow-Up Among African American Patients With Uncontrolled Diabetes.

The management of diabetes, like many other chronic conditions, depends on effective primary care engagement. Patients with diabetes without a usual source of care have a higher risk of uncontrolled disease, hospitalizations, and early death. Our objective was to study the effect of a brief intervention to help patients in medically underserved areas obtain rapid primary care follow-up appointments following hospitalization. We performed a pilot pragmatic randomized controlled trial of adult patients with uncontrolled diabetes who had been admitted to one of three hospitals in the Memphis, TN, area. The enhanced usual care arm received a list of primary care clinics, whereas the intervention group had an appointment made for them preceding their index discharge. Patients in both groups were evaluated for primary care appointment attendance within seven and fourteen days of index discharge. In addition, we examined barriers patients encounter to receiving rapid primary care follow-up using a secret shopper approach to assess wait times when calling primary care offices. Twelve patients were enrolled with six in each trial arm. Baseline demographics, access to medical care, and health literacy were similar across the groups. Primary care follow-up was also similar across the groups; no improvements in follow-up rates were seen in the group receiving assistance with making appointments. Identified barriers to making primary care follow-up appointments included inability to schedule an urgent appointment, long hold times when calling doctor's offices and lack of transportation. Additionally, hold times when calling primary care offices were found to be excessively long in the medically underserved areas studied. The study demonstrates the feasibility of providing patient assistance with scheduling rapid primary care follow-up appointments at the time of discharge and the potential to improve care transitions and access to primary care among patients living in medically underserved areas. Larger pragmatic trials are needed to further test alternative approaches for insuring rapid primary care follow-up in vulnerable patients with ambulatory care-sensitive chronic conditions.

Association of Weight Loss With Type 2 Diabetes Remission Among Adults in Medically Underserved Areas: A Retrospective Cohort Study.

PURPOSE: To examine the association between weight loss and type 2 diabetes remission among vulnerable populations living in medically underserved areas of the Mid-Southern United States. DESIGN: Quantitative, retrospective cohort study. SETTING: 114 ambulatory sites and 5 adults' hospitals in the Mid-South participating in a regional diabetes registry. PARTICIPANTS: 9,900 adult patients with type 2 diabetes, stratified by remission status, with 1 year of baseline electronic medical record data, and 1 year of follow-up data for the 2015-2018 study period. MEASURES: The outcomes were diabetes remissions, categorized as any remission, partial remission, and complete remission based on the guidelines of the American Diabetes Association. The exposure was weight loss, calculated by the change in the Body Mass Index (BMI) as a proxy measure. ANALYSIS: χ2 tests, Fisher's exact tests, and the Mann-Whitney U-test were used to examine the differences in patient characteristics by remission status across the 3 remission categories, as appropriate. Multiple multivariable logistic regressions adjusting for confounders were performed to estimate the adjusted odds ratios (aORs) for the associations between weight loss and diabetes remission. RESULTS: Among 9,900 patients identified, a reduction of 0.3 kg/m2 (standard deviation: 2.5) in the average BMI from the baseline to the follow-up was observed. 10.8% achieved any type of remission, with 9.8% for partial and 1.0% for complete remissions. Greater weight loss was significantly associated with an increased likelihood of any (aOR = 1.07, 95% confidence interval (CI), 1.06-1.08), partial (aOR 1.06, 95% CI, 1.04-1.07), and complete diabetes remission (aOR 1.10, 95% CI, 1.07-1.13). CONCLUSIONS: Weight loss is significantly associated with diabetes remission among patients living in medically underserved areas, but complete remission is rare.

Refining a traditional urban-rural classification approach to better assess heterogeneity of treatment effects in patient-centered outcomes research.

This article describes a rationale and approach for modifying the traditional rural-urban commuting area (RUCA) coding scheme used to classify U.S. ZIP codes to enable suburban/rural vs. urban core comparisons in health outcomes research that better reflect current geographic differences in access to care in U.S. populations at risk for health disparities. The proposed method customization is being employed in the Patient-Centered Outcomes Research Institute-funded Management Of Diabetes in Everyday Life (MODEL) study to assess heterogeneity of treatment effect for patient-centered diabetes self-care interventions across the rural-urban spectrum. The proposed suburban/rural vs. urban core classification scheme modification is based on research showing that increasing suburban poverty and rapid conversion of many rural areas into suburban areas in the U.S. has resulted in similar health care access problems in areas designated as rural or suburban.•The RUCA coding scheme was developed when a much higher percentage of U.S. individuals resided in areas with very low population density.•Using the MODEL study example, this study demonstrates that the RUCA classification scheme using ZIP codes does not reflect real differences in health care access experienced by medically underserved study participants.•Both internal and external validation data suggest that the proposed suburban/rural vs. urban core customization of the RUCA geographic coding scheme better reflects real differences in healthcare access and is better able to assess the differential impact of clinical interventions designed to address geographic differences in access among vulnerable populations.

Time to Development of Overt Diabetes and Macrovascular and Microvascular Complications Among Patients With Prediabetes: A Retrospective Cohort Study.

Objective In this study, we aimed to determine the effect of age, gender, race, and obesity on the development of overt diabetes and macro/microvascular events among patients with prediabetes. Methods This was a retrospective cohort study of patient records available through a national electronic health record (EHR) database from 2012 to 2017. Patients with prediabetes in the baseline year of 2012 were identified. Macro/microvascular events were defined as the diagnosis of myocardial infarction (MI), stroke, or chronic kidney disease (CKD). The effects of age, gender, race, and obesity on the incidence of diabetes and macro/microvascular events between 2013-2017 were assessed using the multivariate Cox proportional-hazards model. Results Among the total 5,230 patients with prediabetes in 2012, 16.7% developed overt diabetes, and 19.7% developed a macro/microvascular event. Elderly patients (HR: 2.96, 95% CI: 2.12-4.13), males (HR: 1.38, 95% CI: 1.20-1.59), and African-Americans (HR: 1.47, 95% CI: 1.26-1.73) were at a higher risk of experiencing a macro/microvascular event. Additionally, male gender (HR: 1.27, 95% CI: 1.11-1.46) and obesity (HR: 1.24, 95% CI: 1.08-1.43) were significant factors associated with the development of overt diabetes. Furthermore, when diabetes status was added as an interaction term to the Cox proportional-hazards model, no statistical difference was found with respect to any of the other independent variables. It can therefore be inferred that those with prediabetes and overt diabetes had a similar risk of developing macro/microvascular events. Conclusions Based on our findings, factors including advanced age, obesity, male gender, and African race significantly impact the progression to diabetes and associated macro/microvascular events.

Using preliminary data and prospective power analyses for mid-stream revision of projected group and subgroup sizes in pragmatic patient-centered outcomes research.

Pragmatic clinical trials are commonly used in patient-centered outcomes research to assess heterogeneity of treatment effects. Patient-Centered Outcomes Research Institute (PCORI) methodology standards for assessing heterogeneity of treatment effects are extremely rigorous, but their implementation in real-world settings can be difficult. Predicting recruitment effectiveness and subgroup characteristics is often challenging and may require mid-stream revision of projected group and subgroup sizes. Yet, little real-world data are available to demonstrate methodologically valid approaches to address situations where such revisions are necessary. These data were used for mid-stream revision of group and subgroup sizes in the Management of Diabetes in Everyday Life (MODEL) clinical trial. The planned number of randomized participants retained over the one-year study period was reduced from 800 to 581 due to recruitment difficulties among potential participants residing in rural areas. Prospective power analyses are based on the revised target of 581 participants retained and the proportions of 167 participants with various key baseline characteristics, who had been randomized in MODEL by January 2018, as reported to the Patient Center Outcomes Research Institute (PCORI) and the MODEL Data Safety and Monitoring Committee. Power calculations are based on two-sided t-tests with type-I error rates of 0.05 and the assumption that effect sizes will range from small (standardized difference = 0.36) to medium (= 0.50). The primary outcome variables are how many days in the previous week participants 1) ate healthy meals, 2) participated in at least 30 minutes of physical activity, and 3) took medications as prescribed. The POWER procedure of SAS 9.4 was used for all analyses. These data, along with the approach, can assist statisticians as they plan future pragmatic clinical trials evaluating heterogeneity of treatment effects. These data can help inform investigators, conducting patient-centered outcomes research, as they define subgroups for either confirmatory analyses for testing heterogeneity of treatment effects or for exploratory analyses where estimation of confidence bounds may be useful for generating future hypotheses. (This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (SC15-1503-28336), www.ClinicalTrials.gov and Identifier: NCT02957513 [1].).

Continuity of Care for Patients with Obesity-Associated Chronic Conditions: Protocol for a Multisite Retrospective Cohort Study.

BACKGROUND: Obesity affects nearly half of adults in the United States and is contributing substantially to a pandemic of obesity-associated chronic conditions such as type 2 diabetes, hypertension, and arthritis. The obesity-associated chronic condition pandemic is particularly severe in low-income, medically underserved, predominantly African-American areas in the southern United States. Little is known regarding the impact of geographic, income, and racial disparities in continuity of care on major health outcomes for patients with obesity-associated chronic conditions. OBJECTIVE: The aim of this study is to assess, among patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes, (1) whether continuity of care is associated with lower overall and potentially preventable emergency department and hospital utilization, (2) the effect of geographic, income, and racial disparities on continuity of care and on health care utilization, (3) whether continuity of care particularly protects individuals at risk for disparities from adverse health outcomes, and (4) whether characteristics of health systems are associated with higher continuity of care and better outcomes. METHODS: Using 2015-2018 data from 4 practice-based research networks participating in the Southern Obesity and Diabetes Coalition, we will conduct a retrospective cohort analysis and distributed meta-analysis. Patients with obesity-associated chronic conditions and with type 2 diabetes will be assessed within each health system, following a standardized study protocol. The primary study outcomes are overall and preventable emergency department visits and hospitalizations. Continuity of care will be calculated at the facility level using a modified version of the Bice-Boxerman continuity of care index. Race will be assessed using electronic medical record data. Residence in a low-income area or a health professional shortage area respectively will be assessed by linking patient residence ZIP codes to the Centers for Medicare & Medicaid Services database. RESULTS: In 4 regional health systems across Tennessee, Mississippi, Louisiana, and Arkansas, a total of 53 adult hospitals were included in the study. A total of 147,889 patients with obesity-associated chronic conditions who met study criteria were identified in these health systems, of which 45,453 patients met the type 2 diabetes criteria for inclusion. Results are expected by the end of 2020. CONCLUSIONS: This study should reveal whether health system efforts to increase continuity of care for patients with obesity and diabetes have potential to improve outcomes and reduce costs. Analyzing disparities in continuity of care and their effect on major health outcomes can help demonstrate how to improve care and use of health care resources for vulnerable patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes. Better understanding of the association between continuity and health care utilization for these vulnerable populations will contribute to the development of higher-value health systems in the southern United States. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20788.

A mid-South chronic disease registry and practice-based research network to address disparities.

OBJECTIVES: To describe an innovative health information technology (HIT) model for supporting community-wide health improvement through multiprovider collaboration in a regional population health registry and practice-based research network (PBRN). STUDY DESIGN: Case study. METHODS: We describe the HIT data structure and governance of the Diabetes Wellness and Prevention Coalition (DWPC) Registry and PBRN based in Memphis, Tennessee. The population served and their characteristics were assessed for all adult patients with at least 1 encounter in a participating health care delivery system from January 1, 2013, to March 31, 2019. Disparities in access and health care utilization were assessed by residential zip code. RESULTS: The DWPC Registry is a chronic disease and population health data warehouse designed to facilitate chronic disease surveillance and tracking of processes and outcomes of care in medically underserved areas of the mid-South. The Registry primarily focuses on obesity-associated chronic conditions such as diabetes, hypertension, hyperlipidemia, and chronic kidney disease. It combines patient data from 7 regional health systems, which include 6 adult hospitals and more than 50 outpatient practices, covering 462,223 adults with 2,032,425 clinic visits and 602,679 hospitalizations and/or emergency department visits from January 1, 2013, to March 31, 2019. The most prevalent chronic conditions include obesity (37.2%), hypertension (34.4%), overweight (26.4%), hyperlipidemia (18.0%), and type 2 diabetes (14.0%). The Registry provides quarterly practice improvement reports to participating clinics, facilitates surveillance of and outreach to patients with unmet health needs, and supports a pragmatic clinical trial and multiple cohort studies. CONCLUSIONS: Regional registries and PBRNs are powerful tools that can support real-world quality improvement and population health efforts to reduce disparities and improve equity in chronic disease care in medically underserved communities across the United States.

The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.

Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.

Medication nonadherence, mental health, opioid use, and inpatient and emergency department use in super-utilizers.

OBJECTIVES: To examine whether mental health conditions, opioid use, and medication nonadherence are associated with inpatient and emergency department (ED) use among Medicare super-utilizers from medically underserved areas. STUDY DESIGN: Retrospective panel study. METHODS: The study included Medicare super-utilizers (≥3 hospitalizations or ≥2 hospitalizations with ≥2 ED visits in 6 months) served by a health system in a medically underserved area in the South from February 2013 to December 2014 with at least 1 filled prescription for hypertension, type 2 diabetes, cardiovascular, and/or chronic obstructive pulmonary disease/asthma medications. We used random effects negative binomial models to assess whether mental health diagnosis, opioid use, and medication nonadherence were associated with preventable and overall hospitalizations and ED visits stratified by age (18-64 vs ≥65 years). RESULTS: Overall chronic disease medication nonadherence was associated with more frequent hospitalizations and ED visits for both younger (hospitalizations: incidence rate ratio [IRR], 1.31; 95% CI, 1.16-1.47; ED visits: IRR, 1.33; 95% CI, 1.14-1.55) and older (hospitalizations: IRR, 1.34; 95% CI, 1.20-1.49; ED visits: IRR, 1.18; 95% CI, 1.02-1.38) beneficiaries. Mental health diagnosis was significantly associated with higher hospitalizations and ED visits among both age groups. Although associations between opioid medication use and inpatient and ED use were inconsistent and not significant in most cases, we found that 7 or more days' supply of opioids was associated with lower preventable hospitalizations in Medicare beneficiaries 65 years or older. CONCLUSIONS: The study findings highlight the importance of improving medication adherence and addressing behavioral health needs in Medicare super-utilizers.

Can primary care access reduce health care utilization for patients with obesity-associated chronic conditions in medically underserved areas?

OBJECTIVES: The prevalence and burdens of obesity-associated chronic conditions (OCC) are rising nationwide, particularly in health professional shortage areas (HPSA). This study examined the impact of access to primary care on health care utilization for vulnerable populations with OCC in the South. METHODS: Adult patients with obesity (BMI ≥ 30 kg/m2 ), greater than or equal to one additional OCC, and self-reported primary care access data were retrospectively identified from hospital and emergency department (ED) electronic medical records of a major health care system in the South. Multivariable logistic regression assessed factors associated with self-reported access to primary care. Multivariable zero-inflated negative binomial models assessed effect of HPSA residence on relationships between self-reported access to primary care and health care utilization. RESULTS: A total of 29 674 patients were identified. Hypertension (76.1%), type 2 diabetes mellitus (34.1%), and hyperlipidemia (32.9%) were the most prevalent OCC. Males (odds ratio [OR]: 0.43; 95% confidence interval [CI], 0.40-0.47), unmarried (OR: 0.69; 95% CI, 0.63-0.76), and uninsured (OR: 0.29; 95% CI, 0.27-0.32) had lower odds of access to primary care. For patients living in HPSA (vs non-HPSA), access to primary care was associated with higher incidence of overall ED use (relative risk [RR]: 1.38; 95% CI, 1.19-1.61) and lower incidence of potentially preventable hospital use (RR: 0.59; 95% CI, 0.38-0.92). CONCLUSION: Paradoxically, access to primary care may increase ED use while reducing potentially preventable hospital utilization for patients with OCC in HPSA. Increasing access to primary care alone, without strengthening its capacity to serve the needs of vulnerable patients, may be insufficient to reduce hospital utilization.