Blood pressure outcomes at 18 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study.

This pragmatic matched cohort study using EHR data extended the follow up to 18 months for BP outcomes comparing individuals prescribed remote patient monitoring (n = 288) and temporally-matched controls (n = 1152) from six primary care practices. After 18 months, the RPM-prescribed cohort had greater BP control < 140/90 mm Hg (RPM cohort: 71.5%, control cohort: 51.9%, p < 0.001) and lower systolic BP (131.6 versus 136.0 mm Hg, p = 0.004) using office and home measurements. BP control at 18 months assessed by office measurements only was also higher in the RPM group (62.2% versus 51.9%, p = 0.004).

Reducing Care Overuse in Older Patients Using Professional Norms and Accountability : A Cluster Randomized Controlled Trial.

BACKGROUND: Effective strategies are needed to curtail overuse that may lead to harm. OBJECTIVE: To evaluate the effects of clinician decision support redirecting attention to harms and engaging social and reputational concerns on overuse in older primary care patients. DESIGN: 18-month, single-blind, pragmatic, cluster randomized trial, constrained randomization. (ClinicalTrials.gov: NCT04289753). SETTING: 60 primary care internal medicine, family medicine and geriatrics practices within a health system from 1 September 2020 to 28 February 2022. PARTICIPANTS: 371 primary care clinicians and their older adult patients from participating practices. INTERVENTION: Behavioral science-informed, point-of-care, clinical decision support tools plus brief case-based education addressing the 3 primary clinical outcomes (187 clinicians from 30 clinics) were compared with brief case-based education alone (187 clinicians from 30 clinics). Decision support was designed to increase salience of potential harms, convey social norms, and promote accountability. MEASUREMENTS: Prostate-specific antigen (PSA) testing in men aged 76 years and older without previous prostate cancer, urine testing for nonspecific reasons in women aged 65 years and older, and overtreatment of diabetes with hypoglycemic agents in patients aged 75 years and older and hemoglobin A1c (HbA1c) less than 7%. RESULTS: At randomization, mean clinic annual PSA testing, unspecified urine testing, and diabetes overtreatment rates were 24.9, 23.9, and 16.8 per 100 patients, respectively. After 18 months of intervention, the intervention group had lower adjusted difference-in-differences in annual rates of PSA testing (-8.7 [95% CI, -10.2 to -7.1]), unspecified urine testing (-5.5 [CI, -7.0 to -3.6]), and diabetes overtreatment (-1.4 [CI, -2.9 to -0.03]) compared with education only. Safety measures did not show increased emergency care related to urinary tract infections or hyperglycemia. An HbA1c greater than 9.0% was more common with the intervention among previously overtreated diabetes patients (adjusted difference-in-differences, 0.47 per 100 patients [95% CI, 0.04 to 1.20]). LIMITATION: A single health system limits generalizability; electronic health data limit ability to differentiate between overtesting and underdocumentation. CONCLUSION: Decision support designed to increase clinicians' attention to possible harms, social norms, and reputational concerns reduced unspecified testing compared with offering traditional case-based education alone. Small decreases in diabetes overtreatment may also result in higher rates of uncontrolled diabetes. PRIMARY FUNDING SOURCE: National Institute on Aging.

Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study.

Remote patient monitoring (RPM) for hypertension enables automatic transmission of blood pressure (BP) and pulse into the electronic health record (EHR), but its effectiveness in primary care is unknown. This pragmatic matched cohort study using EHR data compared BP outcomes between individuals prescribed RPM and temporally-matched controls from six primary care practices. We retrospectively created a cohort of 288 Medicare-enrolled patients prescribed BP RPM (cases) and 1152 propensity score-matched controls (1:4). Matching was based on age, sex, systolic blood pressure (SBP), marital status, and other characteristics. Outcomes at 3, 6, 9 and 12 months were: controlling high BP (most recent BP < 140/90 mm Hg), antihypertensive medication intensification, and most recent SBP assessed using: all measurements, and office measurements only. At baseline, RPM-prescribed patients and controls had similar ages and systolic BP. BP control diverged at 3 months (RPM: 72.2%, control: 51%, p < 0.001). This difference persisted but decreased over follow-up. After 12 months, the RPM-prescribed cohort had greater BP control (RPM: 71.5%, control: 58.1%, p < 0.001) and lower SBP (132.3 versus 136.5 mm Hg, p = 0.003) using all measurements, but they did not differ using only office measurements (12 month BP control: 60.8% versus 58.1%, p = 0.44; SBP: 135.9 versus 136.5 mm Hg, p = 0.91). At 12 months, the most recent BP measurements were more current for RPM-prescribed patients (median [IQR] 8 [0-109] versus 134 [56-239] days). Net increases in antihypertensive medications by 12 months were similar. Implementation of RPM in primary care could inform hypertension management strategies and increase hypertension control. Registration: ClinicalTrials.gov identifier: NCT05562921.

Prospective Cohort Study of Remote Patient Monitoring with and without Care Coordination for Hypertension in Primary Care.

BACKGROUND: Out-of-office blood pressure (BP) measurements contribute valuable information for guiding clinical management of hypertension. Measurements from home devices can be directly transmitted to patients' electronic health record for use in remote monitoring programs. OBJECTIVE: This study aimed to compare in primary care practice care coordinator-assisted implementation of remote patient monitoring (RPM) for hypertension to RPM implementation alone and to usual care. METHODS: This was a pragmatic observational cohort study. Patients aged 65 to 85 years with Medicare insurance from two populations were included: those with uncontrolled hypertension and a general hypertension group seeing primary care physicians (PCPs) within one health system. Exposures were clinic-level availability of RPM plus care coordination, RPM alone, or usual care. At two clinics (13 PCPs), nurse care coordinators with PCP approval offered RPM to patients with uncontrolled office BP and assisted with initiation. At two clinics (39 PCPs), RPM was at PCPs' discretion. Twenty clinics continued usual care. Main measures were controlling high BP (<140/90 mm Hg), last office systolic blood pressure (SBP), and proportion with antihypertensive medication intensification. RESULTS: Among the Medicare cohorts with uncontrolled hypertension, 16.7% (39/234) of patients from the care coordination clinics were prescribed RPM versus <1% (4/600) at noncare coordination sites. RPM-enrolled care coordination group patients had higher baseline SBP than the noncare coordination group (148.8 vs. 140.0 mm Hg). After 6 months, in the uncontrolled hypertension cohorts the prevalences of controlling high BP were 32.5% (RPM with care coordination), 30.7 % (RPM alone), and 27.1% (usual care); multivariable adjusted odds ratios (95% confidence interval) were 1.63 (1.12-2.39; p = 0.011) and 1.29 (0.98-1.69; p = 0.068) compared with usual care, respectively. CONCLUSION: Care coordination facilitated RPM enrollment among poorly controlled hypertension patients and may improve hypertension control in primary care among Medicare patients.

Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching.

Objectives: Since 2019, the Centers for Medicare and Medicaid Services covers remote physiologic monitoring (RPM) for blood pressure (BP) per hypertension diagnosis and treatment guidelines. Here, we integrated Omron VitalSight RPM into the health system's electronic health record to transmit BP and pulse without manual entry, assessed feasibility, and used pragmatic prospective matched cohort studies to assess initial effects in (1) uncontrolled (last two office BP ≥140/90 mmHg) and (2) general (diagnosed hypertension or last office BP ≥140/90 mmHg) hypertension patient populations. Materials and Methods: Seventeen clinicians at two internal medicine practices were oriented. Eligible patients were aged 65-85 years had Medicare insurance with ≥1 office visit in the previous year. We prospectively identified matched controls (age, sex, BP, and number of office visits in previous year) from other primary care practices within the health system and estimated the association between RPM availability (clinic-level) and patient BP outcomes after 6 months. ClinicalTrials.gov: NCT04604925. Results: Feasibility. Uptake was low at pilot clinics: 10 physicians prescribed RPM to 118 patients during the 6-month pilot. This included 7% (14/207) of the prespecified uncontrolled hypertension cohort and 3.3% (78/2356) of the general hypertension cohort. Surveyed clinicians (n = 4) reported changing their patients' medical treatment in response to RPM BPs, although they recommended having a dedicated RN or LPN to review BP readings. Effectiveness. At 6 months, BP control was greater at pilot practices than among matched controls (uncontrolled: 31.4% vs 22.8%; P = .007; general: 64.0% vs 59.7%; P < .001). Systolic BP at last office visit did not differ (mean [SD] 146.0 [15.7] vs 147.1 [15.6]; P = .48) in the uncontrolled population, and was lower in the general population (131.8 [15.7] vs 132.8 [15.9]; P = .04).The frequency of antihypertensive medication changes was similar in both groups (uncontrolled P = .986; general P = .218). Discussion and Conclusions: Uptake notwithstanding, RPM may have improved BP control. A potential mechanism is increased physician awareness of and attention to uncontrolled hypertension. Barriers to RPM use among physicians require further study.

Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol.

The accuracy of Omron 10 Series BP7450 (HEM-7342T-Z), Omron Platinum BP5450 (HEM-7343T-Z), Walmart Equate Premium 8000 Series UA-8000WM, Walgreens Premium 15+ WGNBPA-960BT, and CVS Series 800 BP3MW1-4YCVS were assessed in an adult general population compared to a mercury sphygmomanometer standard according to the ISO 81060-2:2018/AMD 1:2020 validation procedure. Omron selected the monitors and included three non-Omron monitors because they were from large retail vendors in the United States and these monitors did not have accessible results from validation testing. The BP7450, N = 85, passed both criteria for the standard. Mean (SD) differences in paired SBP and DBP determinations between the test device and reference were 0.5 (7.7) and 2.5 (6.8) mm Hg. The BP5450, N = 86, passed both criteria. Mean (SD) differences in paired SBP and DBP determinations were 1.9 (7.0) and 3.6 (6.4) mm Hg. The UA-8000WM, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 2.5 (8.0) and 5.1 (6.4) mm Hg. The WGNBPA-240BT, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 7.9 (8.5) and 5.5 (6.7) mm Hg. The BP3MW1-4YCVS, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 5.8 (8.7) and 3.1 (5.6) mm Hg. These findings emphasize the importance of verifying the validation status of home blood pressure monitors before use by consumers.

Design of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial.

BACKGROUND: Overtesting and treatment of older patients is common and may lead to harms. The Choosing Wisely campaign has provided recommendations to reduce overtesting and overtreatment of older adults. Behavioral economics-informed interventions embedded within the electronic health record (EHR) have been shown to reduce overuse in several areas. Our objective is to conduct a parallel arm, pragmatic cluster-randomized trial to evaluate the effectiveness of behavioral-economics-informed clinical decision support (CDS) interventions previously piloted in primary care clinics and designed to reduce overtesting and overtreatment in older adults. METHODS/DESIGN: This trial has two parallel arms: clinician education alone vs. clinician education plus behavioral-economics-informed CDS. There are three co-primary outcomes for this trial: (1) prostate-specific antigen (PSA) screening in older men, (2) urine testing for non-specific reasons in older women, and (3) overtreatment of diabetes in older adults. All eligible primary care clinics from a large regional health system were randomized using a modified constrained randomization process and their attributed clinicians were included. Clinicians were recruited to complete a survey and educational module. We randomized 60 primary care clinics with 374 primary care clinicians and achieved adequate balance between the study arms for prespecified constrained variables. Baseline annual overuse rates for the three co-primary outcomes were 25%, 23%, and 17% for the PSA, urine, and diabetes measures, respectively. DISCUSSION: This trial is evaluating behavioral-economics-informed EHR-embedded interventions to reduce overuse of specific tests and treatments for older adults. The study will evaluate the effectiveness and safety of these interventions.

Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial.

Importance: Mobile applications (apps) may help improve hypertension self-management. Objective: To investigate the effect of an artificial intelligence smartphone coaching app to promote home monitoring and hypertension-related behaviors on systolic blood pressure level compared with a blood pressure tracking app. Design, Setting, and Participants: This was a 2-group, open, randomized clinical trial. Participants with uncontrolled hypertension were recruited in 2016 and 2017 and were followed up for 6 months. Data analysis was performed from April 2019 to December 2019. Interventions: Intervention group participants received a smartphone coaching app to promote home monitoring and behavioral changes associated with hypertension self-management plus a home blood pressure monitor. Control participants received a blood pressure tracking app plus a home blood pressure monitor. Main Outcomes and Measures: The primary study outcome was systolic blood pressure at 6 months. Secondary outcomes included self-reported antihypertensive medication adherence, home monitoring and self-management practices, measures of self-efficacy associated with blood pressure, weight, and self-reported health behaviors. Results: There were 333 participants randomized, and 297 completed the follow-up assessment. Among the participants who completed the study, the mean (SD) age was 58.9 (12.8) years, 182 (61.3%) were women, and 103 (34.7%) were black. Baseline mean (SD) systolic blood pressure was 140.6 (12.2) mm Hg among intervention participants and 141.8 (13.4) mm Hg among control participants. After 6 months, the corresponding mean (SD) systolic blood pressures were 132.3 (15.0) mm Hg and 135.0 (13.9) mm Hg, with a between-group adjusted difference of -2.0 mm Hg (95% CI, -4.9 mm Hg to 0.8 mm Hg; P = .16). At 6 months, self-confidence in controlling blood pressure was greater in the intervention group (0.36 point on a 5-point scale; 95% CI, 0.18 point to 0.54 point; P < .001). There were no significant differences between the 2 groups in other secondary outcomes. The adjusted difference in self-reported physical activity was 26.7 minutes per week (95% CI, -5.4 minutes per week to 58.8 minutes per week; P = .10). Subgroup analysis raised the possibility that intervention effects differed by age. Conclusions and Relevance: Among individuals with uncontrolled hypertension, those randomized to a smartphone coaching app plus home monitor had similar systolic blood pressure compared with those who received a blood pressure tracking app plus home monitor. Given the direction of the difference in systolic blood pressure between groups and the possibility for differences in treatment effects across subgroups, future studies are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT03288142.

Outreach to Promote Management of Cardiovascular Risk in Primary Care Among Patients With Rheumatoid Arthritis Seen in Rheumatology Practice.

OBJECTIVE: Rheumatoid arthritis (RA) confers a 1.5- to 2.0-fold increased risk of cardiovascular disease (CVD). A prior multifaceted quality improvement approach to improving CVD preventive care increased CVD risk factor assessments, but there was no significant effect on the management of risk factors. We tested the impact of adding a proactive outreach strategy promoting primary care treatment of CVD risk factors among patients with RA through their rheumatology practice. METHODS: Through electronic health record searches, we identified patients with RA who were potential candidates for hypertension treatment initiation or intensification, statin therapy, or a smoking-cessation intervention. A nonclinician care manager contacted patients by phone and mail on behalf of the rheumatologists, provided information about the identified risk factor(s), recommend follow-up with primary care physicians (PCPs), sent correspondence to PCPs, and followed up with patients to see what actions had been taken. We measured preventive cardiology quality indicators and compared preintervention and intervention time periods using interrupted time series methods. RESULTS: During the 6-month intervention period, the proportion of patients prescribed at least moderate-intensity statin treatment for primary prevention rose from 18.4% to 23.8%. The rate of increase was 1.06% greater per month than during the preceding period (P < 0.001). Rates of increase in hypertension diagnosis and control improved more rapidly during this phase (P < 0.001 for each) and reversed preceding negative trends. CONCLUSION: Implementing proactive nonclinician outreach to encourage primary care-based treatment of CVD risk factors was associated with increases in statin prescribing and in hypertension diagnosis and control. Smoking was not affected.

Effects of 2 Forms of Practice Facilitation on Cardiovascular Prevention in Primary Care: A Practice-randomized, Comparative Effectiveness Trial.

BACKGROUND: Effective quality improvement (QI) strategies are needed for small practices. OBJECTIVE: The objective of this study was to compare practice facilitation implementing point-of-care (POC) QI strategies alone versus facilitation implementing point-of-care plus population management (POC+PM) strategies on preventive cardiovascular care. DESIGN: Two arm, practice-randomized, comparative effectiveness study. PARTICIPANTS: Small and mid-sized primary care practices. INTERVENTIONS: Practices worked with facilitators on QI for 12 months to implement POC or POC+PM strategies. MEASURES: Proportion of eligible patients in a practice meeting "ABCS" measures: (Aspirin) Aspirin/antiplatelet therapy for ischemic vascular disease, (Blood pressure) Controlling High Blood Pressure, (Cholesterol) Statin Therapy for the Prevention and Treatment of Cardiovascular Disease, and (Smoking) Tobacco Use: Screening and Cessation Intervention, and the Change Process Capability Questionnaire. Measurements were performed at baseline, 12, and 18 months. RESULTS: A total of 226 practices were randomized, 179 contributed follow-up data. The mean proportion of patients meeting each performance measure was greater at 12 months compared with baseline: Aspirin 0.04 (95% confidence interval: 0.02-0.06), Blood pressure 0.04 (0.02-0.06), Cholesterol 0.05 (0.03-0.07), Smoking 0.05 (0.02-0.07); P<0.001 for each. Improvements were sustained at 18 months. At 12 months, baseline-adjusted difference-in-differences in proportions for the POC+PM arm versus POC was: Aspirin 0.02 (-0.02 to 0.05), Blood pressure -0.01 (-0.04 to 0.03), Cholesterol 0.03 (0.00-0.07), and Smoking 0.02 (-0.02 to 0.06); P>0.05 for all. Change Process Capability Questionnaire improved slightly, mean change 0.30 (0.09-0.51) but did not significantly differ across arms. CONCLUSION: Facilitator-led QI promoting population management approaches plus POC improvement strategies was not clearly superior to POC strategies alone.

Using Electronic Health Records to Measure Quality Improvement Efforts: Findings from a Large Practice Facilitation Initiative.

BACKGROUND: Federal incentives for electronic health record (EHR) use typically require quality measure reporting over calendar year or 90-day periods. However, required reporting periods may not align with time frames of real-world quality improvement (QI) efforts. This study described primary care practices' ability to obtain measures with reporting periods aligning with a large QI initiative. METHODS: Researchers conducted a substudy of a randomized trial testing practice facilitation strategies for preventive cardiovascular care. Three quality measures (aspirin for ischemic vascular disease; blood pressure control for hypertension; smoking screening/cessation) were collected quarterly over one year. The primary outcome was a binary indicator of whether a practice facilitator obtained all three measures with "rolling 12-month" reporting periods (that is, the year preceding each study quarter). RESULTS: The study included 107 practices, 63 (58.9%) of which met the primary outcome of obtaining all measures with rolling 12-month reporting periods. Smaller practices were less likely to meet the primary outcome (p < 0.001). Practices used 11 different EHRs, 3 of which were unable to consistently produce rolling 12-month measures; at 33 practices (30.8%) using these 3 EHRs, facilitators met a secondary outcome of obtaining prior calendar year and rolling 3-month measures. Facilitators reported barriers to data collection such as practices lacking optional EHR features, and EHRs' inability to produce reporting periods across two calendar years. CONCLUSION: EHR vendors' compliance with federal reporting requirements is not necessarily sufficient to support real-world QI work. Improvements are needed in the flexibility and usability of EHRs' quality measurement functions, particularly for smaller practices.

Changes in Care After Implementing a Multifaceted Intervention to Improve Preventive Cardiology Practice in Rheumatoid Arthritis.

Rheumatoid arthritis (RA) increases cardiovascular disease (CVD) risk. However, CVD risk factor identification and treatment is often inadequate. The authors implemented a multifaceted rheumatology practice intervention to improve CVD risk factor measurement, assessment, and management. The intervention included clinician education, point-of-care decision support, feedback, and care management. The authors measured quality indicators from electronic health records and assessed impact with interrupted time series. Following the intervention, more RA patients had all major CVD risk factors assessed (53% vs 72.2%), and the rate of increase was greater during the intervention period than baseline (difference of 0.74% per month, P = .0016). Moderate- or high-intensity statin prescribing increased (21.6% to 28.2%), but the rate of change was not different from baseline. Several other quality measures did not increase. Although CVD risk factor assessment improved, the intervention did not affect risk factor management and control. Other strategies are needed to optimize CVD prevention in RA.

Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study.

BACKGROUND: Hypertension is a major cause of morbidity and mortality but frequently remains uncontrolled. A smartphone application that provides coaching regarding home blood pressure monitoring and other aspects of hypertension self-care and related behavior change may be a scalable way to help manage hypertension. METHODS/DESIGN: The Smart Hypertension Control Study is a prospective, randomized controlled trial to assess the effects of a hypertension personal control program (HPCP), which consists of an automated artificial intelligence smartphone application that provides individualized support and coaching to promote home monitoring and healthy behavior changes related to hypertension self-management. Enrolled adults with uncontrolled hypertension will be randomized in a 1:1 fashion to the HPCP with home blood pressure monitoring or to home monitoring alone. We plan to enroll 350 participants, with a target of 300 participants with complete six-month follow-up data. The primary study outcome will be systolic blood pressure at six months. Additional outcomes include measures of antihypertensive medication adherence, home blood pressure monitoring practices, self-management practices, weight, and self-reported health behaviors. CONCLUSION: The Smart Hypertension Control Study will evaluate blood pressure and hypertension self-management behavior outcomes in participants with uncontrolled hypertension exposed to a smartphone-based hypertension health coaching application in addition to home blood pressure monitoring compared to those exposed to home blood pressure monitoring alone.