Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P=0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P=0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.

Clinical Decision Support for Recognizing and Managing Hypertensive Blood Pressure in Youth: No Significant Impact on Medical Costs.

OBJECTIVE: To evaluate economic costs from the health system perspective of an electronic health record-based clinical decision support (CDS) tool, TeenBP, designed to assist in the recognition and management of hypertension in youth. METHODS: Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14 to 4/14/16. The 12-month change in standardized medical care costs for insured patients aged 10 to 17 years without prior hypertension were calculated for each study arm. The primary analysis compared patients with ≥1 visit with blood pressure (BP) ≥95th percentile (isolated hypertensive BP), and secondary analyses compared patients with ≥3 visits within one year with BP ≥95th percentile (incident hypertension). Generalized estimating equation models estimated the difference-in-differences in costs between groups over time. RESULTS: Among 925 insured patients with an isolated hypertensive BP, the pre-to-post change in overall costs averaged $22 more for TeenBP CDS versus UC patients over 12 months, but this difference was not statistically significant (P = .723). Among 159 insured patients with incident hypertension, the pre-to-post change in overall costs over 12 months was higher by $227 per person on average for TeenBP CDS versus UC patients, but this difference also was not statistically significant (P = .313). CONCLUSIONS: The TeenBP CDS intervention was previously found to significantly improve identification and management of hypertensive BP in youth, and in this study, we find that this tool did not significantly increase care costs in its first 12 months of clinical use.

Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure.

BACKGROUND: Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S. POPULATION: Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care. AIMS/OBJECTIVES: To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research. METHODS: The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects. CONCLUSION: This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.

Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial.

BACKGROUND: Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice. OBJECTIVE: To analyze the economic outcomes of the Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure (Hyperlink) study, a cluster randomized controlled trial which used home blood pressure telemonitoring and pharmacist case management to achieve better blood pressure control in patients with uncontrolled hypertension. METHODS: A prospective analysis compared differences in medical costs and encounters in the Hyperlink telemonitoring intervention and usual care groups in the 12 months pre- and post-enrollment using medical and pharmacy insurance claims from a health care sector perspective. Generalized estimating equation models were used to estimate differences between groups over time. These results, combined with previously published prospective study results on intervention costs and blood pressure outcomes, were used to estimate cost-effectiveness measures for blood pressure control and reduction. FINDINGS: Total medical costs in the intervention group were lower compared with the usual care group by an average of $281 per person, but this difference was not statistically significant. Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group. Statistically significant differences were found in lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs. Patterns in medical costs were similar for medical encounters. On average, the intervention cost $7337 per person achieving hypertension control and $139 or $265 per mm Hg reduction in systolic or diastolic blood pressure, respectively. CONCLUSIONS: Home blood pressure monitoring and pharmacist case management to improve hypertension care can be implemented without increasing, and potentially reducing, overall medical care costs.

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists.

OBJECTIVES: The Hyperlink trial tested a 12-month intervention of home blood pressure (BP) telemonitoring with pharmacist case management in adults with uncontrolled hypertension. The intervention resulted in improved BP control compared with usual care at both 6 (72% vs. 45%; P < 0.001) and 12 months (71% vs. 53%; P = 0.005). We sought to investigate factors contributing to intervention success. DESIGN: Mixed-methods analysis of process of care data, patient focus groups, and pharmacist interviews. PARTICIPANTS: Data from 228 intervention patients were examined from the original 450 patients randomly assigned from 16 primary care clinics. Five patient focus groups and 4 pharmacist interviews were conducted to ascertain the patient and pharmacist perspective. Focus group and interview data were coded, and themes relevant to pharmacists were identified. OUTCOME MEASURES: Home BP readings of less than 135/85 mm Hg and patient focus group and pharmacist interview themes. RESULTS: Mean BP at the intake visit was 148/85 mm Hg. Antihypertensive medications were adjusted in 10% of patients at the initial in-person visit, 33% at phone visit 1, 36% at phone visit 2, and 19% at phone visit 3. Thereafter, medication changes declined. The mean home BP for patients at the first phone visit was 136/80 mm Hg, 126/74 mm Hg at 3 months, and 123/73 mm Hg at 5 months, with little change thereafter. Key components of success from patient and pharmacist interviews included a strong patient-pharmacist relationship, individualized treatment plans, and frequent phone contact with the pharmacist. CONCLUSION: Frequent adjustments to the antihypertensive treatment regimen based on home BP telemonitoring resulted in rapid lowering of BP. Our results suggest that an intensive telephone-based intervention with the key components of medication adjustments, a strong patient and pharmacist relationship, and individualized treatment plans can achieve BP control in only 3 months in many patients with uncontrolled hypertension.

Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial.

Importance: Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (-10.7, -9.7, and -6.6 mm Hg, respectively). Objectives: To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care. Design, Setting, and Participants: Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015. Interventions: A home BP telemonitoring intervention with pharmacist management or usual care. Main Outcomes and Measures: Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit. Results: Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was -2.5 mm Hg (95% CI, -6.3 to 1.2 mm Hg; P = .18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of -1.0 mm Hg (95% CI, -3.2 to 1.2 mm Hg; P = .37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months. Conclusions and Relevance: This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases. Trial Registration: ClinicalTrials.gov Identifier: NCT00781365.

Patient characteristics associated with greater blood pressure control in a randomized trial of home blood pressure telemonitoring and pharmacist management.

This paper reports subgroup analysis of a successful cluster-randomized trial to identify attributes of hypertensive patients who benefited more or less from an intervention combining blood pressure (BP) telemonitoring and pharmacist management. The end point was BP < 140/90 mm Hg at 6-month follow-up. Fourteen baseline patient characteristics were selected a priori as subgroup variables. Among the 351 trial participants, 44% were female, 84% non-Hispanic white, mean age was 60.9 years, and mean BP was 149/86 mm Hg. The overall adjusted odds ratio for BP control in the intervention versus usual care group was 3.64 (P < .001). The effect of the intervention was significantly larger in patients who were younger (interaction P = .02), did not have diabetes (P = .005), had high baseline diastolic BP (P = .02), added salt less than daily in food preparation (P = .007), and took 0-2 (rather than 3-6) antihypertensive medication classes at baseline (P = .02). These findings may help prioritize patients for whom the intervention is most effective.

Proton pump inhibitor use by aspirin-treated coronary artery disease patients is not associated with increased risk of cardiovascular events.

AIMS: Daily low-dose aspirin is recommended for prevention of cardiovascular events in patients with coronary artery disease (CAD), and proton pump inhibitors (PPIs) are recommended to prevent or treat aspirin-associated gastrointestinal injury. Previous studies have reported contradictory findings regarding the risk of major adverse cardiovascular events (MACE) in patients who use PPI with aspirin therapy. We sought to examine associations between PPI use and MACE and all-cause mortality in aspirin-treated CAD patients. METHODS AND RESULTS: Using electronic medical record and healthcare claims data, we conducted a retrospective population-based cohort study to examine patients 40 years or older with a diagnosis of CAD and documented aspirin use. Patients taking clopidogrel or other antiplatelet or anticoagulant agents were excluded. Risk of MACE and all-cause mortality associated with PPI use vs. no PPI use was analysed by Cox proportional hazards regression with standard covariate adjustment. Of the 2011 patients included in the study, 295 (14.7%) used a PPI. During a mean follow-up of 3.1 years, 294 patients [63 PPI users (21.4%) and 231 PPI non-users (13.5%)] experienced an MACE. In the adjusted model, the risk of MACE with PPI treatment was no different than without PPI treatment [hazard ratio (HR) 1.32 (95% confidence interval 0.8-2.4)]. Likewise, there was no difference between groups for risk of all-cause mortality; 201 patients [47 PPI users (15.9%) and 154 PPI non-users (9.0%)] died of any cause [HR 1.33 (0.9-1.9)]. Results were validated by robust propensity score-matching methods (n = 574). CONCLUSIONS: No evidence was found that PPI use is associated with increased risk of MACE or all-cause mortality in aspirin-treated CAD patients.

Change in Weight Status and Development of Hypertension.

OBJECTIVE: To examine the association of BMI percentile and change in BMI percentile to change in blood pressure (BP) percentile and development of hypertension (HTN). METHODS: This retrospective cohort included 101 606 subjects age 3 to 17 years from 3 health systems across the United States. Height, weight, and BPs were extracted from electronic health records, and BMI and BP percentiles were computed with the appropriate age, gender, and height charts. Mixed linear regression estimated change in BP percentile, and proportional hazards regression was used to estimate risk of incident HTN associated with BMI percentile and change in BMI percentile. RESULTS: The largest increases in BP percentile were observed among children and adolescents who became obese or maintained obesity. Over a median 3.1 years of follow-up, 0.3% of subjects developed HTN. Obese children ages 3 to 11 had twofold increased risk of developing HTN compared with healthy weight children. Obese children and adolescents had a twofold increased risk of developing HTN, and severely obese children had a more than fourfold increased risk. Compared with those who maintained a healthy weight, children and adolescents who became obese or maintained obesity had a more than threefold increased risk of incident HTN. CONCLUSIONS: We observed a strong, statistically significant association between increasing BMI percentile and increases in BP percentile, with risk of incident HTN associated primarily with obesity. The adverse impact of weight gain and obesity in this cohort over a short period underscores the early need for effective strategies for prevention of overweight and obesity.

Factors Associated With Adherence to Blood Pressure Measurement Recommendations at Pediatric Primary Care Visits, Minnesota and Colorado, 2007-2010.

INTRODUCTION: Elevated blood pressure in childhood may predict increased cardiovascular risk in young adulthood. The Task Force on the Diagnosis, Evaluation and Treatment of High Blood pressure in Children and Adolescents recommends that blood pressure be measured in children aged 3 years or older at all health care visits. Guidelines from both Bright Futures and the Expert Panel of Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents recommend annual blood pressure screening. Adherence to these guidelines is unknown. METHODS: We conducted a cross-sectional study to assess compliance with blood pressure screening recommendations in 2 integrated health care delivery systems. We analyzed electronic health records of 103,693 subjects aged 3 to 17 years. Probability of blood pressure measurement documented in the electronic health record was modeled as a function of visit type (well-child vs nonwell-child); patient age, sex, race/ethnicity, and body mass index; health care use; insurance type; and type of office practice or clinic department (family practice or pediatrics). RESULTS: Blood pressure was measured at 95% of well-child visits and 69% of nonwell-child outpatient visits. After adjusting for potential confounders, the percentage of nonwell-child visits with measurements increased linearly with patient age (P < .001). Overall, the proportion of children with annual blood pressure measurements was high and increased with age. Family practice clinics were more likely to adhere to blood pressure measurement guidelines compared with pediatric clinics (P < .001). CONCLUSION: These results show good compliance with recommendations for routine blood pressure measurement in children and adolescents. Findings can inform the development of EHR-based clinical decision support tools to augment blood pressure screening and recognition of prehypertension and hypertension in pediatric patients.

A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work?

BACKGROUND: It is important to understand which components of successful multifaceted interventions are responsible for study outcomes, since some components may be more important contributors to the intervention effect than others. OBJECTIVE: We conducted a mediation analysis to determine which of seven factors had the greatest effect on change in systolic blood pressure (BP) after 6 months in a trial to improve hypertension control. DESIGN: The study was a preplanned secondary analysis of a cluster-randomized clinical trial. Eight clinics in an integrated health system were randomized to provide usual care to their patients (n = 222), and eight were randomized to provide a telemonitoring intervention (n = 228). PARTICIPANTS: Four hundred three of 450 trial participants completing the 6-month follow-up visit were included. INTERVENTIONS: Intervention group participants received home BP telemonitors and transmitted measurements to pharmacists, who adjusted medications and provided advice to improve adherence to medications and lifestyle modification via telephone visits. MAIN MEASURES: Path analytic models estimated indirect effects of the seven potential mediators of intervention effect (defined as the difference between the intervention and usual care groups in change in systolic BP from baseline to 6 months). The potential mediators were change in home BP monitor use, number of BP medication classes, adherence to BP medications, physical activity, salt intake, alcohol use, and weight. KEY RESULTS: The difference in change in systolic BP was 11.3 mmHg. The multivariable mediation model explained 47 % (5.3 mmHg) of the intervention effect. Nearly all of this was mediated by two factors: an increase in medication treatment intensity (24 %) and increased home BP monitor use (19 %). The other five factors were not significant mediators, although medication adherence and salt intake improved more in the intervention group than in the usual care group. CONCLUSIONS: Most of the explained intervention effect was attributable to the combination of self-monitoring and medication intensification. High adherence at baseline and the relatively low intensity of resources directed toward lifestyle change may explain why these factors did not contribute to the improvement in BP.

Lipid screening in children and adolescents in community practice: 2007 to 2010.

BACKGROUND: Integrated guidelines on cardiovascular health and risk reduction in children issued in 2011 newly recommended universal screening for dyslipidemia in children at 9 to 11 years and 17 to 21 years. METHODS AND RESULTS: We determined the frequency and results of lipid testing in 301 080 children and adolescents aged 3 to 19 enrolled in 3 large US health systems in 2007 to 2010 before the 2011 guidelines were issued. Overall, 9.8% of the study population was tested for lipids. The proportion tested varied by body mass index percentile (5.9% of normal weight, 10.8% of overweight, and 26.9% of obese children) and age (8.9% of 9- to 11-year olds and 24.3% of 17- to 19-year olds). In normal weight individuals, 2.8% of 9- to 11-year olds and 22.0% of 17- to 19-year olds were tested. In multivariable models, age and body mass index category remained strongly associated with lipid testing. Sex, race, ethnicity, and blood pressure were weakly associated with testing. Abnormal lipid levels were found in 8.6% for total cholesterol, 22.5% for high-density lipoprotein-cholesterol, 12.0% for non-high-density lipoprotein-cholesterol, 8.0% for low-density lipoprotein-cholesterol, and 21% for triglycerides (age, 10-19 years). There was a strong and graded association of abnormal lipid levels with body mass index, particularly for high-density lipoprotein-cholesterol and triglycerides (2- to 6-fold higher odds ratio in obese when compared with that in normal weight children). CONCLUSIONS: Lipid screening was uncommon in 9- to 11-year olds and was performed in a minority of 17- to 19-year olds during 2007 to 2010. These data serve as a benchmark for assessing change in practice patterns after the new recommendations for pediatric lipid screening and management.

Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial.

IMPORTANCE: Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension. OBJECTIVES: To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped. DESIGN, SETTING, AND PATIENTS: A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up. INTERVENTIONS: Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly. MAIN OUTCOMES AND MEASURES: Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped). RESULTS: At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07). CONCLUSIONS AND RELEVANCE: Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00781365.

Patterns of care and persistence after incident elevated blood pressure.

BACKGROUND AND OBJECTIVE: Screening for hypertension in children occurs during routine care. When blood pressure (BP) is elevated in the hypertensive range, a repeat measurement within 1 to 2 weeks is recommended. The objective was to assess patterns of care after an incident elevated BP, including timing of repeat BP measurement and likelihood of persistently elevated BP. METHODS: This retrospective study was conducted in 3 health care organizations. All children aged 3 through 17 years with an incident elevated BP at an outpatient visit during 2007 through 2010 were identified. Within this group, we assessed the proportion who had a repeat BP measured within 1 month of their incident elevated BP and the proportion who subsequently met the definition of hypertension. Multivariate analyses were used to identify factors associated with follow-up BP within 1 month of initial elevated BP. RESULTS: Among 72,625 children and adolescents in the population, 6108 (8.4%) had an incident elevated BP during the study period. Among 6108 with an incident elevated BP, 20.9% had a repeat BP measured within 1 month. In multivariate analyses, having a follow-up BP within 1 month was not significantly more likely among individuals with obesity or stage 2 systolic elevation. Among 6108 individuals with an incident elevated BP, 84 (1.4%) had a second and third consecutive elevated BP within 12 months. CONCLUSIONS: Whereas >8% of children and adolescents had an incident elevated BP, the great majority of BPs were not repeated within 1 month. However, relatively few individuals subsequently met the definition of hypertension.

Benefits of early hypertension control on cardiovascular outcomes in patients with diabetes.

OBJECTIVE: To assess the impact of early hypertension (HT) control on occurrence of subsequent major cardiovascular events in those with diabetes and recent-onset HT. RESEARCH DESIGN AND METHODS: Study subjects were 15,665 adults with diabetes but no diagnosed coronary or cerebrovascular disease at baseline who met standard criteria for new-onset HT. Poisson regression models assessed whether adequate blood pressure control within 1 year of HT onset predicts subsequent occurrence of major cardiovascular events with and without adjustment for baseline Framingham Risk Score (FRS) and other covariates. RESULTS: Mean age was 51.5 years, and mean blood pressure at HT onset was 136.8/80.8 mmHg. In the year after HT onset, mean blood pressure decreased to 131.4/78.0 mmHg and was <130/80 mmHg in 32.9% of subjects and <140/90 mmHg in 80.2%. Over a mean follow-up of 3.2 years, age-adjusted rates of major cardiovascular events in those with mean 1-year blood pressure measurements of <130/80, 130-139/80-89, and ≥140/90 mmHg were 5.10, 4.27, and 6.94 events/1,000 person-years, respectively (P = 0.004). In FRS-adjusted models, rates of major cardiovascular events were significantly higher in those with mean blood pressure ≥140/90 mmHg in the first year after HT onset (rate ratio 1.30 [95% CI 1.01-1.169]; P = 0.04). CONCLUSIONS: Failure to adequately control BP within 1 year of HT onset significantly increased the likelihood of major cardiovascular events within 3 years. Prompt control of new-onset HT in patients with diabetes may provide important short-term clinical benefits.

Comparative effectiveness of 2 ß-blockers in hypertensive patients.

BACKGROUND: Randomized controlled trials have demonstrated the efficacy of selected ß-blockers for preventing cardiovascular (CV) events in patients following myocardial infarction (MI) or with heart failure (HF). However, the effectiveness of ß-blockers for preventing CV events in patients with hypertension has been questioned recently, but it is unclear whether this is a class effect. METHODS: Using electronic medical record and health plan data from the Cardiovascular Research Network Hypertension Registry, we compared incident MI, HF, and stroke in patients who were new ß-blocker users between 2000 and 2009. Patients had no history of CV disease and had not previously filled a prescription for a ß-blocker. Cox proportional hazards regression was used to examine the associations of atenolol and metoprolol tartrate with incident CV events using both standard covariate adjustment (n = 120,978) and propensity score-matching methods (n = 22,352). RESULTS: During follow-up (median, 5.2 years), there were 3517 incident MI, 3272 incident HF, and 3664 incident stroke events. Hazard ratios for MI, HF, and stroke in metoprolol tartrate users were 0.99 (95% CI, 0.97-1.02), 0.99 (95% CI, 0.96-1.01), and 0.99 (95% CI, 0.97-1.02), respectively. An alternative approach using propensity score matching yielded similar results in 11,176 new metoprolol tartrate users, who were similar to 11,176 new atenolol users with regard to demographic and clinical characteristics. CONCLUSIONS: There were no statistically significant differences in incident CV events between atenolol and metoprolol tartrate users with hypertension. Large registries similar to the one used in this analysis may be useful for addressing comparative effectiveness questions that are unlikely to be resolved by randomized trials.