Process of Engaging Community and Scientific Partners in the Development of the CIRCL-Chicago Study Protocol.

Objectives: Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a "bundle" of evidence-based interventions significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods: The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results: The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions: The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.

Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.

BACKGROUND: Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy. OBJECTIVE: The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP < 180 and DBP < 110 mm Hg and patients on monotherapy with SBP < 160 and DBP < 100 mm Hg. METHODS/DESIGN: QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care. DISCUSSION: QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.

Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study.

BACKGROUND: Older adults with chronic pain, opioid use, and opioid use disorder (OUD) present complex management decisions in primary care. Clinical tools are needed to improve care delivery. This study protocol describes the planned implementation and evaluation of I-COPE (Improving Chicago Older Adult Opioid and Pain Management through Patient-centered Clinical Decision Support and Project ECHO®) to improve care for this population. METHODS: This study uses a pragmatic, expanding cohort stepped-wedge design to assess the outcomes. The study will be implemented in 35 clinical sites across metropolitan Chicago for patients aged ≥ 65 with chronic pain, opioid use, or OUD who receive primary care at one of the clinics. I-COPE includes the integration of patient-reported data on symptoms and preferences, clinical decision support tools, and a shared decision-making tool into routine primary care for more effective management of chronic pain, opioid prescribing, and OUD in older adults. Primary care providers will be trained through web-based videos and an optional Project ECHO® course, entitled "Pain Management and OUD in Older Adults." The RE-AIM framework will be used to assess the I-COPE implementation. Effectiveness outcomes will include an increased variety of recommended pain treatments, decreased prescriptions of higher-risk pain treatments, and decreased patient pain scores. All outcomes will be evaluated 6 and 12 months after implementation. PCPs participating in Project ECHO® will be evaluated on changes in knowledge, attitudes, and self-efficacy using pre- and post-course surveys. DISCUSSION: This study will provide evidence about the effectiveness of collecting patient-reported data on symptoms and treatment preferences and providing clinical decision support and shared decision-making tools to improve management for older adults with chronic pain, opioid use, and OUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04878562 .

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes.

PURPOSE: Examine a clinic-based approach to improve food security and glycemic control among patients with diabetes. DESIGN: One-group repeated-measures design. SETTING: Federally Qualified Health Centers in a large Midwest city. SAMPLE: Of the 933 patients with diabetes who consented at baseline, 398 (42.66%) returned during the follow-up period for a visit that included Hemoglobin A1c (HbA1c) results. INTERVENTION: Integrated social medicine approach that includes food insecurity screening, nutrition education, and assistance accessing food resources as a standard-of-care practice designed to minimize disruptions in how patients and providers experience medical care. MEASURES: HbA1c collected as part of a standard blood panel. ANALYSIS: Repeated-measure, mixed-effect linear regression models. RESULTS: There was a decrease in mean HbA1c (Δ = -0.22, P = 0.01) over the study period. The model examining change over time, glycemic control (GC), and food security status (F1, 352 = 5.80, P = 0.02) indicated that among participants with poor GC (33.12%), food secure (FS) participants exhibited significantly greater levels of improvement than food insecure (FI) participants (Δ = -0.55, P = 0.04). Among participants with good GC, changes in HbA1c were not significantly different between FS and FI participants (Δ = 0.23, P = 0.21). CONCLUSION: Providing nutrition education and food assistance improved HbA1c profiles among FS and FI participants, but FI participants may face social and structural challenges that require additional support from health care teams.

A Multipronged Initiative to Improve Productivity and Patient Access in a Federally Qualified Health Center Network.

In 2012, Access Community Health Network, a Federally Qualified Health Center (FQHC) network with 36 health centers serving the greater Chicago area, embarked on a 3-year initiative to improve patient access. "Dramatic Performance Improvement" (DPI) included the adoption of modified open access scheduling and practice changes designed to improve capacity and the ability to balance supply and demand. This article describes DPI implementation, strategies, and associated outcomes, including a 20% decrease in no-show rate, a 33% drop in time to the third next available appointment (TNAA), a 37% decrease in cycle time, and a 13% increase in patient satisfaction.

Associations between obesity and asthma in a low-income, urban, minority population.

BACKGROUND: Community-based studies of obesity, asthma, biomarkers of oxidative stress, and adipokines among low-income, urban, minority populations are lacking. Oxidative stress, perhaps modulated by adipokines, may increase airway inflammation in obese individuals. OBJECTIVES: To characterize associations between obesity and asthma in a low-income, urban, minority community and evaluate adipokines, biomarkers of inflammation, and oxidant-antioxidant balance in association with asthma and obesity. METHODS: A door-to-door evaluation of asthma and obesity prevalence was performed in a low-income housing development. Nonsmoking adults and children underwent additional evaluation, including allergy skin testing, and measures of serum adipokines, and indicators of oxidative stress in blood and exhaled breath. RESULTS: The prevalences of current asthma and a body mass index in the 85th percentile or higher were 15.8% and 35.3%, respectively, among 350 nonsmokers older than 4 years. Asthma and obesity were not associated with one another (odds ratio, 1.0; 95% confidence interval, 0.55-1.84). Among 116 nonsmoking participants who underwent biomarker evaluation, obesity was not associated with exhaled nitric oxide. In multivariate logistic models that adjusted for age category, sex, and a body mass index in 85th percentile or higher, leptin concentrations in the highest quartile were associated with asthma (odds ratio, 8.34; 95% confidence interval, 1.29-50.2) but not with atopy. Adiponectin was associated with total antioxidant capacity in exhaled breath. CONCLUSION: Asthma and obesity, although both common in a low-income, minority community, were not associated with one another. Nevertheless, adipokines were associated with asthma status and with markers of oxidative stress in the lungs, providing some support for an adipokine-inflammatory mechanistic link between the two conditions.