Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial.

BACKGROUND: Shortening time between office visits for patients with uncontrolled hypertension represents a potential strategy for improving blood pressure (BP). OBJECTIVE: We evaluated the impact of multimodal strategies on time between visits and on improvement in systolic BP (SBP) among patients with uncontrolled hypertension. DESIGN: We used a stepped-wedge cluster randomized controlled trial with three wedges involving 12 federally qualified health centers with three study periods: pre-intervention, intervention, and post-intervention. PARTICIPANTS: Adult patients with diagnosed hypertension and two BPs ≥ 140/90 pre-randomization and at least one visit during post-randomization control period (N = 4277). INTERVENTION: The core intervention included three, clinician hypertension group-based trainings, monthly clinician feedback reports, and monthly meetings with practice champions to facilitate implementation. MAIN MEASURES: The main measures were change in time between visits when BP was not controlled and change in SBP. A secondary planned outcome was changed in BP control among all hypertension patients in the practices. KEY RESULTS: Median follow-up times were 34, 32, and 32 days and the mean SBPs were 142.0, 139.5, and 139.8 mmHg, respectively. In adjusted analyses, the intervention did not improve time to the next visit compared with control periods, HR = 1.01 (95% CI: 0.98, 1.04). SBP was reduced by 1.13 mmHg (95% CI: -2.10, -0.16), but was not maintained during follow-up. Hypertension control (< 140/90) in the practices improved by 5% during intervention (95% CI: 2.6%, 7.3%) and was sustained post-intervention 5.4% (95% CI: 2.6%, 8.2%). CONCLUSIONS: The intervention failed to shorten follow-up time for patients with uncontrolled BP and showed very small, statistically significant improvements in SBP that were not sustained. However, the intervention showed statistically and clinically relevant improvement in hypertension control suggesting that the intervention affected clinician decision-making regarding BP control apart from visit frequency. Future practice initiatives should consider hypertension control as a primary outcome. CLINICAL TRIAL: www.ClinicalTrials.gov Identifier: NCT02164331.

Implementing DASH-aligned Congregate Meals and Self-Measured Blood Pressure in two senior centers: An open label study.

BACKGROUND AND AIMS: Cardiovascular Disease (CVD) poses significant health risks for seniors, especially among low-income and minority communities. Senior centers offer multiple services. We tested whether implementing two evidence-based interventions- DASH-aligned meals provided through an existing congregate meal program, and support for home Self-Measured Blood Pressure (SMBP) monitoring-lowers blood pressure among participants at two senior centers serving low-income, racially diverse communities. METHODS AND RESULTS: Open-label study, enrolling clients aged ≥60, eating ≥4 meals/week at two NYC senior centers. Participants received DASH-aligned congregate meals, and training in nutrition, BP management education, and personal SMBP device. Co-Primary outcomes: a) change in systolic BP measured by independent health professionals, and b) change in percent with "controlled BP" (Eighth Joint National Committee (JNC-8) Guidelines), at Month 1 compared to Baseline. SECONDARY OUTCOMES: Changes in BP at Months 3 and 5/6 (last measure). We enrolled 94 participants; COVID closures interrupted implementation mid-study. Mean systolic BP at Month-1 changed by -4.41 mmHg (n = 61 p = 0.07) compared to Baseline. Participants with controlled BP increased (15.7%) at Month 1. Change in mean BP at Month 1 was significantly correlated with BMI (p = 0.02), age (p = 0.04), and baseline BP (p < 0.001). Mean systolic SMBP changed by -6.9 mmHg (p = 0.004) at Months 5/6. CONCLUSIONS: Implementing an evidence-based multi-component BP-lowering intervention within existing congregate meal programs at senior centers serving minority and low-income communities is feasible, and early findings show promising evidence of effectiveness. This approach to cardiovascular risk reduction should be further tested for widespread adoption and impact. Registered on ClinicalTrials.gov NCT03993808 (June 21st, 2019).

Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

BACKGROUND: Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. METHODS AND RESULTS: Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). CONCLUSIONS: A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00233220.

Molecular Types of Methicillin-Resistant Staphylococcus aureus and Methicillin-Sensitive S. aureus Strains Causing Skin and Soft Tissue Infections and Nasal Colonization, Identified in Community Health Centers in New York City.

In November 2011, The Rockefeller University Center for Clinical and Translational Science (CCTS), the Laboratory of Microbiology and Infectious Diseases, and Clinical Directors Network (CDN) launched a research and learning collaborative project with six community health centers in the New York City metropolitan area to determine the nature (clonal type) of community-acquired Staphylococcus aureus strains causing skin and soft tissue infections (SSTIs). Between November 2011 and March 2013, wound and nasal samples from 129 patients with active SSTIs suspicious for S. aureus were collected and characterized by molecular typing techniques. In 63 of 129 patients, the skin wounds were infected by S. aureus: methicillin-resistant S. aureus (MRSA) was recovered from 39 wounds and methicillin-sensitive S. aureus (MSSA) was recovered from 24. Most-46 of the 63-wound isolates belonged to the CC8/Panton-Valentine leukocidin-positive (PVL(+)) group of S. aureus clone USA300: 34 of these strains were MRSA and 12 were MSSA. Of the 63 patients with S. aureus infections, 30 were also colonized by S. aureus in the nares: 16 of the colonizing isolates were MRSA, and 14 were MSSA, and the majority of the colonizing isolates belonged to the USA300 clonal group. In most cases (70%), the colonizing isolate belonged to the same clonal type as the strain involved with the infection. In three of the patients, the identity of invasive and colonizing MRSA isolates was further documented by whole-genome sequencing.

Blood Pressure Visit Intensification Study in Treatment: Trial design.

BACKGROUND: There is a presumption that, for patients with uncontrolled blood pressure (BP), early follow-up, that is, within 4 weeks of an elevated reading, improves BP control. However, data are lacking regarding effective interventions for increasing clinician frequency of follow-up visits and whether such interventions improve BP control. METHODS/DESIGN: Blood Pressure Visit Intensification Study in Treatment involves a multimodal approach to improving intensity of follow-up in 12 community health centers using a stepped wedge study design. DISCUSSION: The study will inform effective interventions for increasing frequency of follow-up visits among patients with uncontrolled BP and determine whether increasing follow-up frequency is associated with better BP control.

Molecular Epidemiologic and Geo-Spatial Characterization of Staphylococcus aureus Cultured from Skin and Soft Tissue Infections from United States-Born and Immigrant Patients Living in New York City.

(1) Background: With increasing international travel and mass population displacement due to war, famine, climate change, and immigration, pathogens, such as Staphylococcus aureus (S. aureus), can also spread across borders. Methicillin-resistant S. aureus (MRSA) most commonly causes skin and soft tissue infections (SSTIs), as well as more invasive infections. One clonal strain, S. aureus USA300, originating in the United States, has spread worldwide. We hypothesized that S. aureus USA300 would still be the leading clonal strain among US-born compared to non-US-born residents, even though risk factors for SSTIs may be similar in these two populations (2) Methods: In this study, 421 participants presenting with SSTIs were enrolled from six community health centers (CHCs) in New York City. The prevalence, risk factors, and molecular characteristics for MRSA and specifically clonal strain USA300 were examined in relation to the patients' self-identified country of birth. (3) Results: Patients born in the US were more likely to have S. aureus SSTIs identified as MRSA USA300. While being male and sharing hygiene products with others were also significant risks for MRSA SSTI, we found exposure to animals, such as owning a pet or working at an animal facility, was specifically associated with risk for SSTIs caused by MRSA USA300. Latin American USA300 variant (LV USA300) was most common in participants born in Latin America. Spatial analysis showed that MRSA USA300 SSTI cases were more clustered together compared to other clonal types either from MRSA or methicillin-sensitive S. aureus (MSSA) SSTI cases. (4) Conclusions: Immigrants with S. aureus infections have unique risk factors and S. aureus molecular characteristics that may differ from US-born patients. Hence, it is important to identify birthplace in MRSA surveillance and monitoring. Spatial analysis may also capture additional information for surveillance that other methods do not.

Stakeholder Engagement In a Comparative Effectiveness/Implementation Study to Prevent Staphylococcus Aureus Infection Recurrence: CA-MRSA Project (CAMP2).

BACKGROUND: Methicillin-resistant or methicillin-sensitive Staphylococcus aureus skin and soft tissue infections pose serious clinical and public health challenges. Few protocols exist for outpatient education, decolonization and decontamination. OBJECTIVES: This trial implemented infection prevention protocols in homes via community health workers/Promotoras. METHODS: We engaged clinicians, patient stakeholders, clinical and laboratory researchers, New York-based federally qualified health centers and community hospital emergency departments. The Clinician and Patient Stakeholder Advisory Committee (CPSAC) convened in person and remotely for shared decision-making and trial oversight. RESULTS: The intervention trial consented participants with skin and soft tissue infections from Methicillin-resistant Staphylococcus aureus or methicillin-sensitive Staphylococcus aureus, completed home visits, obtained surveillance cultures from index patients and household members and sampled household environmental surfaces at baseline and three months. LESSONS LEARNED: The retention of the CPSAC during the trial demonstrated high levels of engagement. CONCLUSIONS: CPSAC was highly effective throughout design and execution by troubleshooting recruitment and home visit challenges.

Implementing DASH-Aligned Meals and Self-Measured Blood Pressure to Reduce Hypertension at Senior Centers: A RE-AIM Analysis.

Low-income, minority seniors face high rates of hypertension that increase cardiovascular risk. Senior centers offer services, including congregate meals, that can be a valuable platform to reach older adults in underserved communities. We implemented two evidence-based interventions not previously tested in this setting: DASH-aligned congregate meals and Self-Measured Blood Pressure (SMBP), to lower blood pressure (BP) at two senior centers serving low-income, racially diverse communities. The study enrolled congregate meal program participants, provided training and support for SMPB, and nutrition and BP education. DASH-aligned meals delivered 40% (lunch) or 70% (breakfast and lunch) of DASH requirements/day. Primary outcomes were change in BP, and BP control, at Month 1. Implementation data collected included client characteristics, menu fidelity, meal attendance, SMBP adherence, meal satisfaction, input from partner organizations and stakeholders, effort, and food costs. We used the RE-AIM framework to analyze implementation. Study Reach included 94 older, racially diverse participants reflecting neighborhood characteristics. Effectiveness: change in systolic BP at Month 1 trended towards significance (-4 mmHg, p = 0.07); change in SMBP reached significance at Month 6 (-6.9 mmHg, p = 0.004). We leveraged existing community-academic partnerships, leading to Adoption at both target sites. The COVID pandemic interrupted Implementation and Maintenance and may have attenuated BP effectiveness. DASH meals served were largely aligned with planned menus. Meal attendance remained consistent; meal satisfaction was high. Food costs increased by 10%. This RE-AIM analysis highlights the acceptability, feasibility, and fidelity of this DASH/SMBP health intervention to lower BP at senior centers. It encourages future research and offers important lessons for organizations delivering services to older adults and addressing cardiovascular risk among vulnerable populations.

Comparative Effectiveness Study of Home-Based Interventions to Prevent CA-MRSA Infection Recurrence.

Recurrent skin and soft tissue infections (SSTI) caused by Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) or Methicillin-Sensitive Staphylococcus aureus (CA-MSSA) present treatment challenges. This community-based trial examined the effectiveness of an evidence-based intervention (CDC Guidelines, topical decolonization, surface decontamination) to reduce SSTI recurrence, mitigate household contamination/transmission, and improve patient-reported outcomes. Participants (n = 186) were individuals with confirmed MRSA(+)/MSSA(+) SSTIs and their household members. During home visits; Community Health Workers/Promotoras provided hygiene instructions; a five-day supply of nasal mupirocin; chlorhexidine for body cleansing; and household disinfecting wipes (Experimental; EXP) or Usual Care Control (UC CON) pamphlets. Primary outcome was six-month SSTI recurrence from electronic health records (EHR). Home visits (months 0; 3) and telephone assessments (months 0; 1; 6) collected self-report data. Index patients and participating household members provided surveillance culture swabs. Secondary outcomes included household surface contamination; household member colonization and transmission; quality of life; and satisfaction with care. There were no significant differences in SSTI recurrence between EXP and UC in the intent-to-treat cohort (n = 186) or the enrolled cohort (n = 119). EXP participants showed reduced but non-significant colonization rates. EXP and UC did not differ in household member transmission, contaminated surfaces, or patient-reported outcomes. This intervention did not reduce clinician-reported MRSA/MSSA SSTI recurrence. Taken together with other recent studies that employed more intensive decolonization protocols, it is possible that a promotora-delivered intervention instructing treatment for a longer or repetitive duration may be effective and should be examined by future studies.

Using attendance data for social network analysis of a community-engaged research partnership.

BACKGROUND: The Rockefeller University Center for Clinical and Translational Science (RU-CCTS) and Clinical Directors Network (CDN), a Practice-Based Research Network (PBRN), fostered a community-academic research partnership involving Community Health Center (CHCs) clinicians, laboratory scientists, clinical researchers, community, and patient partners. From 2011 to 2018, the partnership designed and completed Community-Associated Methicillin-Resistant Staphylococcus Aureus Project (CAMP1), an observational study funded by the National Center for Advancing Translational Sciences (NCATS), and CAMP2, a Comparative Effectiveness Research Study funded by the Patient-Centered Outcomes Research Institute (PCORI). We conducted a social network analysis (SNA) to characterize this Community-Engaged Research (CEnR) partnership. METHODS: Projects incorporated principles of Community-Based Participatory Research (CAMP1/2) and PCORI engagement rubrics (CAMP2). Meetings were designed to be highly interactive, facilitate co-learning, share governance, and incentivize ongoing engagement. Meeting attendance formed the raw dataset enriched by stakeholder roles and affiliations. We used SNA software (Gephi) to form networks for four project periods, characterize network attributes (density, degree, centrality, vulnerability), and create sociograms. Polynomial regression models were used to study stakeholder interactions. RESULTS: Forty-seven progress meetings engaged 141 stakeholders, fulfilling 7 roles, and affiliated with 28 organizations (6 types). Network size, density, and interactions across organizations increased over time. Interactions between Community Members or Recruiters/Community Health Workers and almost every other role increased significantly across CAMP2 (P < 0.005); Community Members' centrality to the network increased over time. CONCLUSIONS: In a partnership with a highly interactive meeting model, SNA using operational attendance data afforded a view of stakeholder interactions that realized the engagement goals of the partnership.

Theoretical and Pragmatic Adaptation of the 5As Model to Patient-Centered Hypertension Counselling.

Patient-centered communication is a means for engaging patients in partnership. However, patient centered communication has not always been grounded in theory or in clinicians' pragmatic needs. The objective of this report is to present a practical approach to hypertension counselling that uses the 5As framework and is grounded in theory and best communication practices.

The medication Adherence and Blood Pressure Control (ABC) trial: a multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population.

The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been published in which objective measures of adherence (electronic pill bottles) were used to assess the effectiveness of these behavioral interventions for hypertension. This study tested a combination of commercially-available interventions that can be easily accessed by health care providers and patients, and therefore may provide a real-world solution to the problem of non-adherence among hypertensives. The aim of the ABC Trial was to test the effectiveness of a stepped care intervention in improving both medication adherence to an antihypertensive medication regimen and BP control. Step 1 of the intervention employed home Self-BP Monitoring (SBPM); at this stage, there were two arms: (1) Usual Care (UC) and (2) Intervention. At Step 2, patients in the intervention arm whose BP had not come under control after 3 months were further randomized to one of two conditions: (1) continuation of SBPM (alone) or (2) continuation of SBPM plus telephone-based nurse case management (SBPM+NCM). Electronic Medication Event Monitoring (MEMS) was the primary measure of medication adherence, and in-office BP was the primary measure of hypertension control. We present an overview of the study design, details of the administrative structure of the study and a description of clinical site recruitment, patient recruitment, and follow-up assessments.

From the Bench to the Barbershop: Community Engagement to Raise Awareness About Community-Acquired Methicillin-Resistant Staphylococcus aureus and Hepatitis C Virus Infection.

BACKGROUND: Infectious diseases, such as hepatitis C and community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA), are emerging health issues. OBJECTIVES: The CA-MRSA Project (CAMP1) extended its learning collaborative to the barbershop/hair salon settings to increase awareness and prevention of CA-MRSA and hepatitis C infections. METHODS: Education sessions on CA-MRSA and hepatitis C were conducted with 43 estheticians at nine barbershop/hair salons in New York City. All completed pre-post intervention knowledge tests. Low-cost primary care referral cards were also distributed in the CA-MRSA education project. RESULTS: Knowledge about CA-MRSA risks (p < .0003) and infection prevention measures (p < .0001), as well as hepatitis C knowledge and prevention (both p < .0001) increased. Nine shops received referral cards (n = 500) and 4% of the cards (n = 19) were distributed to clients. No self-referrals were reported. CONCLUSIONS: CAMP1 successfully recruited and trained a cadre of estheticians on CA-MRSA and hepatitis C prevention increasing their health knowledge deepening our engagement with the community.

Recurrent furunculosis caused by a community-acquired Staphylococcus aureus strain belonging to the USA300 clone.

BACKGROUND: A 24-year-old female with recurrent skin and soft tissue infections (SSTI) was enrolled as part of a multicenter observational cohort study conducted by a practice-based research network (PBRN) on community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). METHODS: Strains were characterized by pulsed-field gel electrophoresis (PFGE), spa typing, and multilocus sequence typing. MRSA strains were analyzed for SCCmec type and the presence of the Panton-Valentine leukocidin (PVL) and arginine catabolic mobile element (ACME) using PCR. RESULTS: In the first episode, S. aureus was recovered from the wound and inguinal folds; in the second, S. aureus was recovered from a lower abdomen furuncle, inguinal folds, and patellar fold. Molecular typing identified CA-MRSA clone USA300 in all samples as spa-type t008, ST8, SCCmecIVa, and a typical PFGE pattern. The strain carried virulence genes pvl and ACME type I. Five SSTI episodes were documented despite successful resolution by antibiotic treatment, with and without incision and drainage. CONCLUSIONS: The source of the USA300 strain remains unknown. The isolate may represent a persistent strain capable of surviving extensive antibiotic pressure or a persistent environmental reservoir may be the source, possibly in the patient's household, from which bacteria were repeatedly introduced into the skin flora with subsequent infections.

Counseling African Americans to Control Hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks.

Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive blacks. The goal of this study is to evaluate the effectiveness of a multilevel, multicomponent, evidence-based intervention compared with usual care in improving BP control among hypertensive blacks who receive care in community health centers. The primary outcomes are BP control rate at 12 months and maintenance of intervention 1 year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost-effectiveness of the intervention. Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with 2 conditions: intervention condition and usual care. Thirty community health centers were randomly assigned equally to the intervention condition group (n=15) or the usual care group (n=15). The intervention comprises 3 components targeted at patients (interactive computerized hypertension education, home BP monitoring, and monthly behavioral counseling on lifestyle modification) and 2 components targeted at physicians (monthly case rounds based on Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines, chart audit and provision of feedback on clinical performance and patients' home BP readings). All outcomes are assessed at quarterly study visits for 1 year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Poor BP control is one of the major reasons for the mortality gap between blacks and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population.