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Background Uncontrolled blood pressure (BP) remains a leading cause of death in the United States. The American Medical Association developed a quality improvement program to improve BP control, but it is unclear how to efficiently implement this program at scale across multiple health systems. Methods and Results We conducted BP MAP (Blood Pressure Measure Accurately, Act Rapidly, and Partner With Patients), a comparative effectiveness trial with clinic‐level randomization to compare 2 scalable versions of the quality improvement program: Full Support (with support from quality improvement expert) and Self‐Guided (using only online materials). Outcomes were clinic‐level BP control (<140/90 mm Hg) and other BP‐related process metrics calculated using electronic health record data. Difference‐in‐differences were used to compare changes in outcomes from baseline to 6 months, between intervention arms, and to a nonrandomized Usual Care arm composed of 18 health systems. A total of 24 safety‐net clinics in 9 different health systems underwent randomization and then simultaneous implementation. BP control increased from 56.7% to 59.1% in the Full Support arm, and 62.0% to 63.1% in the Self‐Guided arm, whereas BP control dropped slightly from 61.3% to 60.9% in the Usual Care arm. The between‐group differences‐in‐differences were not statistically significant (Full Support versus Self‐Guided=+1.2% [95% CI, −3.2% to 5.6%], P =0.59; Full Support versus Usual Care=+3.2% [−0.5% to 6.9%], P =0.09; Self‐Guided versus Usual Care=+2.0% [−0.4% to 4.5%], P =0.10). Conclusions In this randomized trial, 2 methods of implementing a quality improvement intervention in 24 safety net clinics led to modest improvements in BP control that were not statistically significant. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03818659.

ImportanceLate-onset meningitis (LOM) has been associated with adverse neurodevelopmental outcomes in children born extremely preterm.ObjectiveTo report the incidence of LOM during birth hospitalization and neurodevelopmental outcomes at 18 to 26 months’ corrected age.Design, Setting, and ParticipantsThis cohort study is a secondary analysis of a multicenter prospective cohort of children born at 22 to 26 weeks’ gestation between 2003 and 2017 with follow-up from 2004 to 2021. The study was conducted at 25 Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers.ExposuresCulture-confirmed LOM.Main Outcomes and MeasuresIncidence and microbiology of LOM (2003-2017); lumbar puncture (LP) performance in late-onset sepsis (LOS) evaluations (2011-2017); composite outcome of death or neurodevelopmental impairment (NDI; 2004-2021).ResultsAmong 13 372 infants (median [IQR] gestational age, 25.4 [24.4-26.1] weeks; 6864 [51%] boys), LOM was diagnosed in 167 (1%); LOS without LOM in 4564 (34%); and neither LOS nor LOM in 8641 (65%). The observed incidence of LOM decreased from 2% (95% CI, 1%-3%) in 2003 to 0.4% (95% CI, 0.7%-1.0%) in 2017 (P &amp;lt; .001). LP performance in LOS evaluations decreased from 36% (95% CI, 33%-40%) in 2011 to 24% (95% CI, 21%-27%) in 2017 (P &amp;lt; .001). Among infants with culture-confirmed LOS, LP performance decreased from 58% (95% CI, 51%-65%) to 45% (95% CI, 38%-51%; P = .008). LP performance varied by center among all LOS evaluations (10%-59%, P &amp;lt; .001) and among those with culture-confirmed LOS (23%-79%, P &amp;lt; .001). LOM occurred in the absence of concurrent LOS in 27 of 167 cases (16%). The most common LOM isolates were coagulase-negative Staphylococcus (98 [59%]), Candida albicans (38 [23%]), and Escherichia coli (27 [16%]). Death or NDI occurred in 22 of 46 children (48%) with LOM due to coagulase-negative Staphylococcus, 43 of 67 (64%) due to all other bacterial pathogens, and 26 of 33 (79%) due to fungal pathogens. The adjusted relative risk of death or NDI was increased among children with LOM (aOR, 1.53; 95% CI, 1.04-2.25) and among those with LOS without LOM (aOR, 1.41; 95% CI, 1.29-1.54) compared with children with neither infection.Conclusions and RelevanceIn this cohort study, LP was performed with decreasing frequency, and the observed incidence of LOM also decreased. Both LOM and LOS were associated with increased risk of death or NDI; risk varied by LOM pathogen. The full association of LOM with outcomes of children born extremely preterm may be underestimated by current diagnostic practices.

ImportanceSelf-measured blood pressure (SMBP) with commercially available connected smartphone applications may help patients effectively use SMBP measurements.ObjectiveTo determine if enhanced SMBP paired with a connected smartphone application was superior to standard SMBP for blood pressure (BP) reduction or patient satisfaction.Design, Setting, and ParticipantsThis randomized clinical trial was conducted among 23 health systems participating in PCORnet, the National Patient-Centered Clinical Research Network, and included patients who reported having uncontrolled BP at their last clinic visit, a desire to lower their BP, and a smartphone. Enrollment and randomization occurred from August 3, 2019, to December 31, 2020, which was followed by 6 months of follow-up for each patient. Analysis commenced shortly thereafter.InterventionsEligible participants were randomly assigned to enhanced SMBP using a device that paired with a connected smartphone application (enhanced) or a standard device (standard). Participants received their device in the mail, along with web-based educational materials and phone-based support as needed. No clinician engagement was undertaken, and the study provided no special mechanisms for delivering measurements to clinicians for use in BP management.Main Outcomes and MeasuresReduction in systolic BP, defined as the difference between clinic BP at baseline and the most recent clinic BP extracted from electronic health records at 6 months.ResultsEnrolled participants (1051 enhanced [50.0%] vs 1050 standard [50.0%]; 1191 women [56.7%]) were mostly middle-aged or older (mean [SD] age, 58 [13] years), nearly a third were Black or Hispanic (645 [31%]), and most were relatively comfortable using technology (mean [SD], 4.1 [1.1] of 5). The mean (SD) change in systolic BP from baseline to 6 months was −10.8 (18) mm Hg vs −10.6 (18) mm Hg (enhanced vs standard: adjusted difference, −0.19 mm Hg; 95% CI, −1.83 to 1.44;P = .81). Secondary outcomes were mostly null, except for documented attainment of BP control to lower than 140/&amp;lt;90 mm Hg, which occurred in 32% enhanced vs 29% standard groups (odds ratio, 1.15; 95% CI, 1.01-1.34). Most participants were very likely to recommend their SMBP device to a friend (70% vs 69%).Conclusions and RelevanceThis randomized clinical trial found that enhanced SMBP paired with a smartphone application is not superior to standard SMBP for BP reduction or patient satisfaction.Trial RegistrationClinicalTrials.gov Identifier:NCT03796689

Background The National Patient‐Centered Clinical Research Network Blood Pressure Control Laboratory Surveillance System was established to identify opportunities for blood pressure (BP) control improvement and to provide a mechanism for tracking improvement longitudinally. Methods and Results We conducted a serial cross‐sectional study with queries against standardized electronic health record data in the National Patient‐Centered Clinical Research Network (PCORnet) common data model returned by 25 participating US health systems. Queries produced BP control metrics for adults with well‐documented hypertension and a recent encounter at the health system for a series of 1‐year measurement periods for each quarter of available data from January 2017 to March 2020. Aggregate weighted results are presented overall and by race and ethnicity. The most recent measurement period includes data from 1 737 995 patients, and 11 956 509 patient‐years were included in the trend analysis. Overall, 15% were Black, 52% women, and 28% had diabetes. BP control (<140/90 mm Hg) was observed in 62% (range, 44%–74%) but varied by race and ethnicity, with the lowest BP control among Black patients at 57% (odds ratio, 0.79; 95% CI, 0.66–0.94). A new class of antihypertensive medication (medication intensification) was prescribed in just 12% (range, 0.6%–25%) of patient visits where BP was uncontrolled. However, when medication intensification occurred, there was a large decrease in systolic BP (≈15 mm Hg; range, 5–18 mm Hg). Conclusions Major opportunities exist for improving BP control and reducing disparities, especially through consistent medication intensification when BP is uncontrolled. These data demonstrate substantial room for improvement and opportunities to close health equity gaps.

7029 Background: CBP501, a synthetic duodecapeptide, enhances the cytotoxicity of cisplatin in cell lines and xenografts, including NCI-H226 human mesothelioma. CBP501 increases cisplatin influx into tumor cells through an interaction with calmodulin, and inhibits cell cycle progression by abrogating DNA repair at the G2 checkpoint. Phase I clinical trials combining CBP501 with cisplatin alone or with pemetrexed showed acceptable safety profiles and suggested activity. The most common toxicity of CBP501 is infusion-related urticaria, which is easily managed with diphenhydramine. Methods: Chemotherapy-naive patients with unresectable MPM were stratified by histology (epithelioid vs other) and performance status (PS 0-1 vs 2) and randomized 2:1 to Arm A: pemetrexed/cisplatin plus CBP501 25 mg/m2 IV (42 pts planned), or Arm B: pemetrexed/cisplatin alone at standard doses (21 pts planned). Patients continued on treatment until progression or intolerance; no maintenance therapy was delivered. The primary endpoint is progression free survival (PFS) in Arm A; if > 23 of the 42 patients remain free of progression more than 4 months, the combination will be deemed worthy of further study. In addition to standard CT imaging to assess response and PFS, PET scans, pulmonary function tests, and mesothelin levels were performed. Results: Enrollment was completed in October 2011. 65 pts from 14 institutions were randomized, and 63 were treated. Patient characteristics in the two arms were similar and as follows: median age 65, 82% male, 71% epithelioid histology, 8% PS2. Grade 3/4 treatment-related toxicities were uncommon, no different than expected from standard chemotherapy, and comparable in the two arms. 70% of patients treated with CBP501 had infusion reactions, all grade 1-2. The best overall response rate in evaluable patients (modified RECIST, investigator assessed) was 12/37 (32%) (95% CI 18-50) in Arm A, and 3/22 (14%) (95% CI 3-35) in Arm B. The median number of chemotherapy cycles was 5.5 in Arm A, 5 in Arm B. Conclusions: Data on the primary endpoint of PFS in Arm A are maturing and will be presented at the meeting.

Background: Uncontrolled blood pressure (BP) is a leading preventable cause of death that remains common in the US population despite the availability of effective medications. New technology and program innovation has high potential to improve BP but may be expensive and burdensome for patients, clinicians, health systems, and payers and may not produce desired results or reduce existing disparities in BP control. Methods and Results: The PCORnet Blood Pressure Control Laboratory is a platform designed to enable national surveillance and facilitate quality improvement and comparative effectiveness research. The platform uses PCORnet, the National Patient-Centered Clinical Research Network, for engagement of health systems and collection of electronic health record data, and the Eureka Research Platform for eConsent and collection of patient-reported outcomes and mHealth data from wearable devices and smartphones. Three demonstration projects are underway: BP track will conduct national surveillance of BP control and related clinical processes by measuring theory-derived pragmatic BP control metrics using electronic health record data, with a focus on tracking disparities over time; BP MAP will conduct a cluster-randomized trial comparing effectiveness of 2 versions of a BP control quality improvement program; BP Home will conduct an individual patient-level randomized trial comparing effectiveness of smartphone-linked versus standard home BP monitoring. Thus far, BP Track has collected electronic health record data from over 826 000 eligible patients with hypertension who completed ≈3.1 million ambulatory visits. Preliminary results demonstrate substantial room for improvement in BP control (<140/90 mm Hg), which was 58% overall, and in the clinical processes relevant for BP control. For example, only 12% of patients with hypertension with a high BP measurement during an ambulatory visit received an order for a new antihypertensive medication. Conclusions: The PCORnet Blood Pressure Control Laboratory is designed to be a reusable platform for efficient surveillance and comparative effectiveness research; results from demonstration projects are forthcoming.

Background: The Patient-Centered Outcomes Research Institute (PCORI) funded National Blood Pressure Surveillance System (BP Track) is a new national system that generates quarterly metrics of blood pressure (BP) control and BP-related quality metrics for participating healthcare systems from electronic health record (EHR) data. Methods: Queries against standardized EHR data in the national Patient-Centered Clinical Research Network (PCORnet) Common Data Model format produce a set of quality metrics relevant to improving BP control, including Controlling High BP (NQF 0018) and Improvement in BP (CMS65v7), and eight process measures specific to clinical management and treatment practices for improving BP control ( Table ). The metrics, aggregated overall and by health system are reported back to health systems via user-friendly Tableau dashboards, and allow for observation of metric trends. Results: To date, 19 datamarts have contributed EHR data from 1,177,232 patients who met the eligibility criteria for the BP Control measure and 4,454,729 encounters that included a BP measurement during the measurement period. Average age was 62 years; 10% were young adults (<45 years), 17% were African American, 52% female, 28% had diabetes, 15% had coronary heart disease, and 14% had depression. Results demonstrate substantial opportunity for improvement in overall BP control (60% with BP<140/<90 mmHg, range: 42-72%), and many healthcare processes, including medication intensification (12%, 0.6-22%) and use of fixed dose combination medications (24%, 0-88%, Table ). Conclusion: Major opportunities exist for improving BP control, especially in improving the frequency and quality of BP medication prescribing for patients with high BP. The BP Track National BP Surveillance System will track these metrics, by demographic subgroup and over time, and will generate data that can guide and focus quality improvement initiatives aimed at effective BP management.

Background: New technology and healthcare delivery approaches may help improve blood pressure (BP) control. Randomized controlled trials (RCTs) can demonstrate effectiveness of these emerging approaches, both overall and especially within underserved populations, but RCTs are expensive. Our objective is to establish a national platform to support BP control surveillance and efficient RCTs. Methods: The PCORnet BP Control Laboratory, designed and launched in partnership with the American Heart Association (AHA) and the American Medical Association (AMA), leverages electronic health record (EHR) systems throughout the US, the National Patient-Centered Outcomes Research Network (PCORnet), and the NIH-funded Eureka Research Platform, which enables direct-to-participant research including collection of patient-reported outcomes and mHealth data from wearable devices and smartphones. We will use these resources to 1) Conduct national surveillance through quarterly EHR data queries to calculate and track institution- and clinic-level BP control metrics across 23 PCORnet institutions, overall and within key subgroups, and support participation in the AHA/AMA’s Target:BP recognition program (BP Track); 2) Compare effectiveness of a Full Support versus Self-Guided version of the AMA’s Measure Accurately, Act Rapidly, and Partner with Patients (MAP) program at improving BP control in a cluster randomized trial of 24 safety net clinics (BP MAP); and 3) Compare effectiveness of Smartphone-linked versus standard home BP monitoring at reducing systolic BP in an individual-level, direct-to-participant RCT of 2000 patients with uncontrolled BP (BP Home). Results: Preliminary BP Track queries demonstrate an overall BP control rate of 56%, lower control in Black patients (51%), substantial heterogeneity in clinic-level metrics (e.g., 33% vs. 64% BP control), and low rates of medication intensification (9% prescribed a new medication class when BP was high). BP Track will launch PCORnet-wide queries in June; BP MAP in May; and BP Home in August 2019. Conclusions: Feasibility testing is underway to determine if the PCORnet BP Control Laboratory will be useful for investigators interested in conducting efficient RCTs of BP control interventions.