The Design and Rationale of a Multicenter Real-World Trial: The Southeastern Collaboration To Improve Blood Pressure Control in the US Black Belt – Addressing the Triple Threat

BACKGROUND: Impoverished African Americans (AA) with hypertension face poor health outcomes. PURPOSE: To conduct a cluster-randomized trial testing two interventions, alone and in combination, to improve blood pressure (BP) control in AA with persistently uncontrolled hypertension. METHODS: We engaged primary care practices serving rural Alabama and North Carolina residents, and in each practice we recruited approximately 25 AA adults with persistently uncontrolled hypertension (mean systolic BP \u3e140 mmHg over the year prior to enrollment plus enrollment day BP assessed by research assistants ≥140/90 mmHg). Practices were randomized to peer coaching (PC), practice facilitation (PF), both PC and PF (PC + PF), or enhanced usual care (EUC). Coaches met with participants from PC and PC + PF practices weekly for 8 weeks then monthly over one year, discussing lifestyle changes, medication adherence, home monitoring, and communication with the healthcare team. Facilitators met with PF and PC + PF practices monthly to implement ≥1 quality improvement intervention in each of four domains. Data were collected at 0, 6, and 12 months. RESULTS: We recruited 69 practices and 1596 participants; 18 practices (408 participants) were randomized to EUC, 16 (384 participants) to PF, 19 (424 participants) to PC, and 16 (380 participants) to PC + PF. Participants had mean age 57 years, 61% were women, and 56% reported annual income \u3c$20,000. LIMITATIONS: The PF intervention acts at the practice level, possibly missing intervention effects in trial participants. Neither PC nor PF currently has established clinical reimbursement mechanisms. CONCLUSIONS: This trial will fill evidence gaps regarding practice-level vs. patient-level interventions for rural impoverished AA with uncontrolled hypertension

Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial

IMPORTANCE: Rural Black participants need effective intervention to achieve better blood pressure (BP) control. OBJECTIVE: Among Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control. DESIGN, SETTING, AND PARTICIPANTS: A cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022. INTERVENTIONS: Practice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months. RESULTS: A total of 69 practices were randomized, and 1209 participants\u27 data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial\u27s participants. CONCLUSIONS AND RELEVANCE: The results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults

Identification of outliers and positive deviants for healthcare improvement: looking for high performers in hypoglycemia safety in patients with diabetes

Abstract Background The study objectives were to determine: (1) how statistical outliers exhibiting low rates of diabetes overtreatment performed on a reciprocal measure – rates of diabetes undertreatment; and (2) the impact of different criteria on high performing outlier status. Methods The design was serial cross-sectional, using yearly Veterans Health Administration (VHA) administrative data (2009–2013). Our primary outcome measure was facility rate of HbA1c overtreatment of diabetes in patients at risk for hypoglycemia. Outlier status was assessed by using two approaches: calculating a facility outlier value within year, comparator group, and A1c threshold while incorporating at risk population sizes; and examining standardized model residuals across year and A1c threshold. Facilities with outlier values in the lowest decile for all years of data using more than one threshold and comparator or with time-averaged model residuals in the lowest decile for all A1c thresholds were considered high performing outliers. Results Using outlier values, three of the 27 high performers from 2009 were also identified in 2010–2013 and considered outliers. There was only modest overlap between facilities identified as top performers based on three thresholds: A1c  9%) than VA average in the population of patients at high risk for hypoglycemia. Conclusions Statistical identification of positive deviants for diabetes overtreatment was dependent upon the specific measures and approaches used. Moreover, because two facilities may arrive at the same results via very different pathways, it is important to consider that a “best” practice may actually reflect a separate “worst” practice

Myocardial infarction and physical function: the REasons for Geographic And Racial Differences in Stroke prospective cohort study

Objective To examine associations between myocardial infarction (MI) and multiple physical function metrics.Methods Among participants aged≥45 years in the REasons for Geographic And Racial Differences in Stroke prospective cohort study, instrumental activities of daily living (IADL), activities of daily living (ADL), gait speed, chair stands and Short Form-12 physical component summary (PCS) were assessed after approximately 10 years of follow-up. We examined associations between MI and physical function (no MI (n=9472), adjudicated MI during follow-up (n=288, median 4.7 years prior to function assessment), history of MI at baseline (n=745), history of MI at baseline and adjudicated MI during follow-up (n=70, median of 6.7 years prior to function assessment)). Models were adjusted for sociodemographic characteristics, health behaviours, depressive symptoms, cognitive impairment, body mass index, diabetes, hypertension and urinary albumin to creatinine ratio. We examined subgroups defined by age, gender and race.Results The average age at baseline was 62 years old, 56% were women and 35% were black. MI was significantly associated with worse IADL and ADL scores, IADL dependency, chair stands and PCS, but not ADL dependency or gait speed. For example, compared with participants without MI, IADL scores (possible range 0–14, higher score represents worse function) were greater for participants with MI during follow-up (difference: 0.37 (95% CI 0.16 to 0.59)), MI at baseline (0.26 (95% CI 0.12 to 0.41)) and MI at baseline and follow-up (0.71 (95% CI 0.15 to 1.26)), p<0.001. Associations tended to be greater in magnitude among participants who were women and particularly black women.Conclusion MI was associated with various measures of physical function. These decrements in function associated with MI may be preventable or treatable

State-Level Variability in Veteran Reliance on Veterans Health Administration and Potentially Preventable Hospitalizations: A Geospatial Analysis

Most Veterans who use the Veterans Health Administration (VHA) also utilize private-sector health care providers. To better inform local and regional health care planning, we assessed the association between reliance on VHA ambulatory care and total and system-specific preventable hospitalization rates (PHRs) at the state level. We conducted a retrospective dynamic cohort study using Veterans with diabetes mellitus, aged 66 years or older, and dually enrolled in VHA and Medicare parts A and B from 2004 to 2010. While controlling for median age and proportion of males, we measured the association between reliance on VHA ambulatory care and PHRs at the state level using multivariable ordinary least square regression, geographically weighted regression, and generalized additive models. We measured geospatial patterns in PHRs using global Moran’s I and univariate local indicator spatial analysis. Approximately 30% of hospitalized Veterans experienced a preventable hospitalization. Reliance on VHA ambulatory care at the state level ranged from 13.92% to 67.78% and was generally not associated with PHRs. Geospatial analysis consistently identified a cluster of western states with low PHRs from 2006 to 2010. Given the generally low reliance on VHA ambulatory care and lack of association between this reliance and PHRs, policy changes to improve Veterans’ health care outcomes should address private-sector care in addition to VHA care

State-Level Variability in Veteran Reliance on Veterans Health Administration and Potentially Preventable Hospitalizations: A Geospatial Analysis

Most Veterans who use the Veterans Health Administration (VHA) also utilize private-sector health care providers. To better inform local and regional health care planning, we assessed the association between reliance on VHA ambulatory care and total and system-specific preventable hospitalization rates (PHRs) at the state level. We conducted a retrospective dynamic cohort study using Veterans with diabetes mellitus, aged 66 years or older, and dually enrolled in VHA and Medicare parts A and B from 2004 to 2010. While controlling for median age and proportion of males, we measured the association between reliance on VHA ambulatory care and PHRs at the state level using multivariable ordinary least square regression, geographically weighted regression, and generalized additive models. We measured geospatial patterns in PHRs using global Moran’s I and univariate local indicator spatial analysis. Approximately 30% of hospitalized Veterans experienced a preventable hospitalization. Reliance on VHA ambulatory care at the state level ranged from 13.92% to 67.78% and was generally not associated with PHRs. Geospatial analysis consistently identified a cluster of western states with low PHRs from 2006 to 2010. Given the generally low reliance on VHA ambulatory care and lack of association between this reliance and PHRs, policy changes to improve Veterans’ health care outcomes should address private-sector care in addition to VHA care

Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control

Background: Racial disparities related to hypertension prevalence and control persist, with Black persons continuing to have both high prevalence and suboptimal control. The Black Belt region of the US Southeast is characterized by multiple critical priority populations: rural, low-income, and minority (Black). Methods: In a cluster-randomized, controlled, pragmatic implementation trial, the Southeastern Collaboration to Improve Blood Pressure Control evaluated two multi-component, multi-level functional interventions – peer coaching (PC) and practice facilitation (PF) (separately and combined) – as adjuncts to usual care to improve blood pressure control in the Black Belt. The overall goal was to randomize 80 primary care practices (later reduced to 69 practices) in Alabama and North Carolina to one of four interventions: 1) enhanced usual care (EUC); 2) EUC plus PC; 3) EUC plus PF; or 4) EUC plus both PC and PF. Several measures to facilitate recruitment and retention of practices were employed, including practice readiness assessment. Results: Contact was initiated with 248 practices during the study enrollment period. Of these, 99 declined participation, 39 were ineligible, and 41 were being evaluated for inclusion when the target number of practices was reached. The remaining 69 practices eventually were enrolled, with 18 practices randomized to EUC, 19 to PC, 16 to PF, and 16 to PC plus PF. Only two practices (2.9%) were withdrawn during the study. Several facilitators of and barriers to practice recruitment and retention were identified. Conclusion: Our findings underscore the importance of a structured approach to recruiting primary care practices in a pragmatic implementation trial.ClinicalTrials.gov registration number NCT0286666