Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.

Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA).

BACKGROUND: This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management. METHODS AND RESULTS: A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews. At enrollment, 68% of participants (mean [SD] age, 51.7 [11.5] years; 56% self-identified as Hispanic: Mexican ethnicity, 16% as Hispanic: other ethnicity, 16% as Black race, 8% as White race, and 1.6% as South Asian race) reported that their current health depended on blood pressure medications, and 48% were concerned about blood pressure medications. At trial completion, 80% were satisfied with LDQT, 96% were certain the benefits of taking LDQT outweighed the disadvantages, and 96% reported that LDQT was convenient to take. Both patients and health care professionals found LDQT acceptable because it reduced patients' perceived pill burden and facilitated medication adherence. Health care professionals stated that a perceived limitation of LDQT was the inability to titrate doses. Steps to facilitate LDQT implementation include introducing stepped-care combinations and treatment protocols, inclusion in clinical practice guidelines, and eliminating patient cost barriers. CONCLUSIONS: LDQT was an acceptable strategy for hypertension treatment among patients and health care professionals involved in the QUARTET USA clinical trial. Although LDQT was generally perceived as beneficial for maintaining patients' blood pressure control and facilitating adherence, some clinicians perceived limitations in titration inflexibility, adverse effects, and costs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03640312.

Addressing racial disparities in perinatal care for African American/Black individuals in the Chicago community health setting: a qualitative study.

BACKGROUND: There are persistent disparities in maternal and infant perinatal outcomes experienced by Black birthing persons compared with non-Hispanic white (NHW) individuals in the US. The differences in outcomes arise from not only socioeconomic factors and individual health behaviors but also structural racism. Recent research is beginning to elucidate the benefits of patient navigation to support underserved minoritized individuals who experience this constellation of barriers to equitable care. Qualitative research that utilizes both the experiences of Black birthing individuals and the expert opinion of healthcare providers working with them can serve to guide a patient navigation intervention to further decrease disparities in perinatal outcomes. METHODS: We conducted 30 interviews between August and December 2020 with Black birthing individuals in the Chicago metropolitan area and healthcare providers who care for this population both in Chicago and across the nation to explore their experiences, perceptions of barriers to care and ways to decrease inequities. RESULTS: Clinical care team members acknowledged the presence of health disparities experienced by Black pregnant individuals compared with their NHW counterparts stemming from racism, discrimination, and lack of resources. Patients similarly reported personal experiences with these disparities and barriers to care. The successful methods used by clinical care teams to help decrease these differences in the past included patient education on important topics such as breastfeeding and the use of patient advocates. Effectively screening for social determinants of health by someone the patient trusts was also cited as important. Regarding perinatal care practices, clinical care team members described the importance of patient education needs and care team cultural competency. Patients' reported positive and negative experiences corroborated these findings, emphasizing the importance of trust, listening, education, access to care, support, and patient advocacy. Finally, the care team members and patients agreed that active trust-building can help the provider/patient relationship and ultimately improve outcomes. CONCLUSIONS: These qualitative research findings improve the understanding of barriers to care and will help guide development of an intervention to reduce the health disparities experienced by Black pregnant persons.

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 .

The Complex Interplay of Communication and Trust in Healthcare Delivery.

Effective communication in clinician-patient relationships is an essential part of improving health outcomes. Ineffective communication in clinical settings leaves patients feeling undervalued and unheard. Breakdowns in communication can have particularly profound effects on minority or underserved populations, where health disparities already exist. Effective communication is critical for establishing trust, which allows individuals to feel they can share their concerns and questions. Distrust is a particularly important issue in maternal health, where current US rates of maternal mortality and morbidity are 3.1 times higher in Black and African American (AA) pregnant and birthing persons than their non-Hispanic white counterparts. To address the widespread issue of medical distrust and its connection with maternal health outcomes, the OPTIMIZE study is currently implementing an innovative intervention aimed at improving perinatal care for Black/AA pregnant persons. This intervention prompts clinician-patient conversations to enhance communication and repair trust, including a focus on patients' goals, concerns, social determinants of health, and safety. The implications of this intervention are broad, including the potential to improve trust and communication in other clinical specialties.

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.

Associations Between Health Literacy and Medication Self-Management Among Community Health Center Patients with Uncontrolled Hypertension.

PURPOSE: Examine associations between health literacy and several medication self-management constructs among a population of adults with uncontrolled hypertension. PATIENTS AND METHODS: Cross-sectional study of health center patients from the Chicago area with uncontrolled hypertension enrolled between April 2012 and February 2015. Medication self-management constructs-applied to hypertension medications, chronic condition medications and all medications-included: 1) medication reconciliation, 2) knowledge of drug indications, 3) understanding instructions and dosing, and 4) self-reported adherence over 4 days (no missed doses). We determined associations between health literacy and self-management outcomes using multivariable generalized linear regression. RESULTS: There were 1460 patients who completed screening interviews; 62.9% enrolled and had complete baseline data collected, and were included in the analysis. Of 919 participants, 47.4% had likely limited (low), 33.2% possibly limited, and 19.4% likely adequate health literacy. Compared to participants with likely adequate health literacy, participants with low health literacy were less likely to have chronic medications reconciled (18.0% versus 29.6%, p=0.007), know indications for chronic medications (64.1% versus 83.1%, p<0.001), and demonstrate understanding of instructions and dosing (68.1% versus 82.9%, p=0.001). Self-reported adherence to hypertension medications was higher among the low health literacy group (65.6% versus 56.0%, p=0.010). In multivariable models, health literacy was strongly associated with knowledge of drug indications, and understanding of instructions and dosing. CONCLUSION: Low health literacy was associated with worse medication self-management in several domains. However, non-adherence was greatest in the most health literate in unadjusted analysis. Among a population of patients with uncontrolled hypertension, the drivers of poor control may vary by health literacy.

Effect of Electronic Health Record-Based Medication Support and Nurse-Led Medication Therapy Management on Hypertension and Medication Self-management: A Randomized Clinical Trial.

Importance: Complex medication regimens pose self-management challenges, particularly among populations with low levels of health literacy. Objective: To test medication management tools delivered through a commercial electronic health record (EHR) with and without a nurse-led education intervention. Design, Setting, and Participants: This 3-group cluster randomized clinical trial was performed in community health centers in Chicago, Illinois. Participants included 794 patients with hypertension who self-reported using 3 or more medications concurrently (for any purpose). Data were collected from April 30, 2012, through February 29, 2016, and analyzed by intention to treat. Interventions: Clinics were randomly assigned to to groups: electronic health record-based medication management tools (medication review sheets at visit check-in, lay medication information sheets printed after visits; EHR-alone group), EHR-based tools plus nurse-led medication management support (EHR plus education group), or usual care. Main Outcomes and Measures: Outcomes at 12 months included systolic blood pressure (primary outcome), medication reconciliation, knowledge of drug indications, understanding of medication instructions and dosing, and self-reported medication adherence. Medication outcomes were assessed for all hypertension prescriptions, all prescriptions to treat chronic disease, and all medications. Results: Among the 794 participants (68.6% women; mean [SD] age, 52.7 [9.6] years), systolic blood pressure at 12 months was greater in the EHR-alone group compared with the usual care group by 3.6 mm Hg (95% CI, 0.3 to 6.9 mm Hg). Systolic blood pressure in the EHR plus education group was not significantly lower compared with the usual care group (difference, -2.0 mm Hg; 95% CI, -5.2 to 1.3 mm Hg) but was lower compared with the EHR-alone group (-5.6 mm Hg; 95% CI, -8.8 to -2.4 mm Hg). At 12 months, hypertension medication reconciliation was improved in the EHR-alone group (adjusted odds ratio [OR], 1.8; 95% CI, 1.1 to 2.9) and the EHR plus education group (adjusted odds ratio [OR], 2.0; 95% CI, 1.3 to 3.3) compared with usual care. Understanding of medication instructions and dosing was greater in the EHR plus education group than the usual care group for hypertension medications (OR, 2.3; 95% CI, 1.1 to 4.8) and all medications combined (OR, 1.7; 95% CI, 1.0 to 2.8). Compared with usual care, the EHR tools alone and EHR plus education interventions did not improve hypertension medication adherence (OR, 0.9; 95% CI, 0.6-1.4 for both) or knowledge of chronic drug indications (OR for EHR tools alone, 1.0 [95% CI, 0.6 to 1.5] and OR for EHR plus education, 1.1 [95% CI, 0.7-1.7]). Conclusions and Relevance: The study found that EHR tools in isolation improved medication reconciliation but worsened blood pressure. Combining these tools with nurse-led support suggested improved understanding of medication instructions and dosing but did not lower blood pressure compared with usual care. Trial Registration: ClinicalTrials.gov identifier: NCT01578577.

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.

Bringing voice in policy building.

Purpose The purpose of this paper is to describe the use of group concept mapping (GCM) as a tool for developing a conceptual model of an episode of acute, unscheduled care from illness or injury to outcomes such as recovery, death and chronic illness. Design/methodology/approach After generating a literature review drafting an initial conceptual model, GCM software (CS Global MAXTM) is used to organize and identify strengths and directionality between concepts generated through feedback about the model from several stakeholder groups: acute care and non-acute care providers, patients, payers and policymakers. Through online and in-person population-specific focus groups, the GCM approach seeks feedback, assigned relationships and articulated priorities from participants to produce an output map that described overarching concepts and relationships within and across subsamples. Findings A clustered concept map made up of relational data points that produced a taxonomy of feedback was used to update the model for use in soliciting additional feedback from two technical expert panels (TEPs), and finally, a public comment exercise was performed. The results were a stakeholder-informed improved model for an acute care episode, identified factors that influence process and outcomes, and policy recommendations, which were delivered to the Department of Health and Human Services's (DHHS) Assistant Secretary for Preparedness and Response. Practical implications This study provides an example of the value of cross-population multi-stakeholder input to increase voice in shared problem health stakeholder groups. Originality/value This paper provides GCM results and a visual analysis of the relational characteristics both within and across sub-populations involved in the study. It also provides an assessment of observational key factors supporting how different stakeholder voices can be integrated to inform model development and policy recommendations.

Cost-effectiveness analysis of early point-of-care lactate testing in the emergency department.

PURPOSE: To determine the cost-effectiveness of implementing a point-of-care (POC) Lactate Program in the emergency department (ED) for patients with suspected sepsis to identify patients who can benefit from early resuscitation. MATERIALS AND METHODS: We constructed a cost-effectiveness model to examine an ED with 30 000 patients annually. We evaluated a POC lactate program screening patients with suspected sepsis for an elevated lactate ≥4 mmol/L. Those with elevated lactate levels are resuscitated and their lactate clearance is evaluated by serial POC lactate measurements. The POC Lactate Program was compared with a Usual Care Strategy in which all patients with sepsis and an elevated lactate are admitted to the intensive care unit. Costs were estimated from the 2014 Medicare Inpatient and National Physician Fee schedules, and hospital and industry estimates. RESULTS: In the base-case, the POC Lactate Program cost $39.53/patient whereas the Usual Care Strategy cost $33.20/patient. The screened patients in the POC arm resulted in 1.07 quality-adjusted life years for an incremental cost-effectiveness ratio of $31 590 per quality-adjusted life year gained, well below accepted willingness-to-pay-thresholds. CONCLUSIONS: Implementing a POC Lactate Program for screening ED patients with suspected sepsis is a cost-effective intervention to identify patients responsive to early resuscitation.

A Conceptual Model for Episodes of Acute, Unscheduled Care.

We engaged in a 1-year process to develop a conceptual model representing an episode of acute, unscheduled care. Acute, unscheduled care includes acute illnesses (eg, nausea and vomiting), injuries, or exacerbations of chronic conditions (eg, worsening dyspnea in congestive heart failure) and is delivered in emergency departments, urgent care centers, and physicians' offices, as well as through telemedicine. We began with a literature search to define an acute episode of care and to identify existing conceptual models used in health care. In accordance with this information, we then drafted a preliminary conceptual model and collected stakeholder feedback, using online focus groups and concept mapping. Two technical expert panels reviewed the draft model, examined the stakeholder feedback, and discussed ways the model could be improved. After integrating the experts' comments, we solicited public comment on the model and made final revisions. The final conceptual model includes social and individual determinants of health that influence the incidence of acute illness and injury, factors that affect care-seeking decisions, specific delivery settings where acute care is provided, and outcomes and costs associated with the acute care system. We end with recommendations for how researchers, policymakers, payers, patients, and providers can use the model to identify and prioritize ways to improve acute care delivery.

Individual motivation and threat indicators of collaboration readiness in scientific knowledge producing teams: a scoping review and domain analysis.

This paper identifies a gap in the team science literature that considers intrapersonal indicators of collaboration as motivations and threats to participating in collaborative knowledge producing teams (KPTs). Through a scoping review process, over 150 resources were consulted to organize 6 domains of motivation and threat to collaboration in KPTs: Resource Acquisition, Advancing Science, Building Relationships, Knowledge Transfer, Recognition and Reward, and Maintenance of Beliefs. Findings show how domains vary in their presentation of depth and diversity of motivation and threat indicators as well as their relationship with each other within and across domains. The findings of 51 indicators resulting from the review provide a psychosocial framework for which to establish a hierarchy of collaborative reasoning for individual engagement in KPTs thus allowing for further research into the mechanism of collaborative engagement. The indicators serve as a preliminary step in establishing a protocol for testing of the psychometric properties of intrapersonal measures of collaboration readiness.

Pilot analysis of the Motivation Assessment for Team Readiness, Integration, and Collaboration (MATRICx) using Rasch analysis.

Healthcare services and the production of healthcare knowledge are increasingly dependent on highly functioning, multidisciplinary teams, requiring greater awareness of individuals' readiness to collaborate in translational science teams. Yet, there is no comprehensive tool of individual motivations and threats to collaboration that can guide preparation of individuals for work on well-functioning teams. This prospective pilot study evaluated the preliminary psychometric properties of the Motivation Assessment for Team Readiness, Integration, and Collaboration (MATRICx). We examined 55 items of the MATRICx in a sample of 125 faculty, students and researchers, using contemporary psychometric methods (Rasch analysis). We found that the motivator and threat items formed separate constructs relative to collaboration readiness. Further, respondents who identified themselves as inexperienced at working on collaborative projects defined the motivation construct differently from experienced respondents. These results are consistent with differences in strategic alliances described in the literature-for example, inexperienced respondents reflected features of cooperation and coordination, such as concern with sharing information and compatibility of goals. In contrast, the more experienced respondents were concerned with issues that reflected a collective purpose, more typical of collaborative alliances. While these different types of alliances are usually described as representing varying aspects along a continuum, our findings suggest that collaboration might be better thought of as a qualitatively different state than cooperation or coordination. These results need to be replicated in larger samples, but the findings have implications for the development and design of educational interventions that aim to ready scientists and clinicians for greater interdisciplinary work.

Hospital Culture of Transitions in Care: Survey Development.

Understanding hospital culture is important to effectively manage patient flow. The purpose of this study was to develop a survey instrument that can assess a hospital's culture related to in-hospital transitions in care. Key transition themes were identified using a multidisciplinary team of experts from 3 health care systems. Candidate items were rigorously evaluated using a modified Delphi technique. Findings indicate 8 themes associated with hospital culture-mediating transitions. Forty-four items reflect the themes.

The past, present, and future of urgent matters: lessons learned from a decade of emergency department flow improvement.

Over the past decade, emergency departments (ED) have encountered major challenges due to increased crowding and a greater public focus on quality measurement and quality improvement. Responding to these challenges, many EDs have worked to improve their processes and develop new and innovative models of care delivery. Urgent Matters has contributed to ED quality and patient flow improvement by working with hospitals throughout the United States. Recognizing that EDs across the country are struggling with many of the same issues, Urgent Matters-a program funded by the Robert Wood Johnson Foundation (RWJF)-has sought to identify, develop, and disseminate innovative approaches, interventions, and models to improve ED flow and quality. Using a variety of techniques, such as learning networks (collaboratives), national conferences, e-newsletters, webinars, best practices toolkits, and social media, Urgent Matters has served as a thought leader and innovator in ED quality improvement initiatives. The Urgent Matters Seven Success Factors were drawn from the early work done by program participants and propose practical guidelines for implementing and sustaining ED improvement activities. This article chronicles the history, activities, lessons learned, and future of the Urgent Matters program.