Browsing by Subject "Blood Pressure Monitoring, Ambulatory"
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Item Open Access Consideration of Out-of-Office Blood Pressure Monitoring in Hypertension Management.(Journal of clinical hypertension (Greenwich, Conn.), 2016-05) Goldstein, Karen M; Zullig, Leah L; Bosworth, Hayden B; Oddone, Eugene ZItem Open Access Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care?(Circulation. Cardiovascular quality and outcomes, 2014-03) Maciejewski, Matthew L; Bosworth, Hayden B; Olsen, Maren K; Smith, Valerie A; Edelman, David; Powers, Benjamin J; Kaufman, Miriam A; Oddone, Eugene Z; Jackson, George LBackground
Hypertension self-management has been shown to improve systolic blood pressure (BP) control, but longer-term economic and clinical impacts are unknown. The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial.Methods and results
This study is a follow-up analysis of an 18-month, 4-arm, hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions. Clinic-derived systolic blood pressure obtained before, during, and after the trial were estimated using linear mixed models. Inpatient admissions, outpatient expenditures, and total expenditures were estimated using generalized estimating equations. The 3 telephone-based interventions were nurse-administered health behavior promotion, provider-administered medication adjustments based on hypertension treatment guidelines, or a combination of both. Intervention calls were triggered by home BP values transmitted via telemonitoring devices. Clinical and economic outcomes were examined 12 months before, 18 months during, and 18 months after trial completion. Compared with usual care, patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms. Among the patients with inadequate baseline BP control, estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial. Utilization and expenditure trends were similar for patients in all 4 arms.Conclusions
Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion.Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00237692.Item Open Access Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument.(Journal of general internal medicine, 2013-01) Crowley, Matthew J; Grubber, Janet M; Olsen, Maren K; Bosworth, Hayden BBackground
Clinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs.Objectives
1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure.Design
Cross-sectional analysis of randomized trial data.Patients
Six hundred and thirty-six primary care patients with hypertension.Measurements
1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP).Results
We identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP.Conclusions
We identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension.Item Open Access Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.(Archives of internal medicine, 2011-07) Bosworth, Hayden B; Powers, Benjamin J; Olsen, Maren K; McCant, Felicia; Grubber, Janet; Smith, Valerie; Gentry, Pamela W; Rose, Cynthia; Van Houtven, Courtney; Wang, Virginia; Goldstein, Mary K; Oddone, Eugene ZBackground
To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.Methods
Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.Results
The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.Conclusions
Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.Trial registration
clinicaltrials.gov Identifier: NCT00237692.Item Open Access Measuring blood pressure for decision making and quality reporting: where and how many measures?(Annals of internal medicine, 2011-06) Powers, Benjamin J; Olsen, Maren K; Smith, Valerie A; Woolson, Robert F; Bosworth, Hayden B; Oddone, Eugene ZBackground
The optimal setting and number of blood pressure (BP) measurements that should be used for clinical decision making and quality reporting are uncertain.Objective
To compare strategies for home or clinic BP measurement and their effect on classifying patients as having BP that was in or out of control.Design
Secondary analysis of a randomized, controlled trial of strategies to improve hypertension management. (ClinicalTrials.gov registration number: NCT00237692)Setting
Primary care clinics affiliated with the Durham Veterans Affairs Medical Center.Patients
444 veterans with hypertension followed for 18 months.Measurements
Blood pressure was measured repeatedly by using 3 methods: standardized research BP measurements at 6-month intervals; clinic BP measurements obtained during outpatient visits; and home BP measurements using a monitor that transmitted measurements electronically.Results
Patients provided 111,181 systolic BP (SBP) measurements (3218 research, 7121 clinic, and 100,842 home measurements) over 18 months. Systolic BP control rates at baseline (mean SBP<140 mm Hg for clinic or research measurement; <135 mm Hg for home measurement) varied substantially, with 28% classified as in control by clinic measurement, 47% by home measurement, and 68% by research measurement. Short-term variability was large and similar across all 3 methods of measurement, with a mean within-patient coefficient of variation of 10% (range, 1% to 24%). Patients could not be classified as having BP that was in or out of control with 80% certainty on the basis of a single clinic SBP measurement from 120 mm Hg to 157 mm Hg. The effect of within-patient variability could be greatly reduced by averaging several measurements, with most benefit accrued at 5 to 6 measurements.Limitation
The sample was mostly men with a long-standing history of hypertension and was selected on the basis of previous poor BP control.Conclusion
Physicians who want to have 80% or more certainty that they are correctly classifying patients' BP control should use the average of several measurements. Hypertension quality metrics based on a single clinic measurement potentially misclassify a large proportion of patients.Primary funding source
U.S. Department of Veterans Affairs Health Services Research and Development Service.Item Open Access Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.(Contemporary clinical trials, 2016-09) Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, DavidDespite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.Item Open Access Prevention and Control of Hypertension: JACC Health Promotion Series.(Journal of the American College of Cardiology, 2018-09) Carey, Robert M; Muntner, Paul; Bosworth, Hayden B; Whelton, Paul KHypertension, the leading risk factor for cardiovascular disease, originates from combined genetic, environmental, and social determinants. Environmental factors include overweight/obesity, unhealthy diet, excessive dietary sodium, inadequate dietary potassium, insufficient physical activity, and consumption of alcohol. Prevention and control of hypertension can be achieved through targeted and/or population-based strategies. For control of hypertension, the targeted strategy involves interventions to increase awareness, treatment, and control in individuals. Corresponding population-based strategies involve interventions designed to achieve a small reduction in blood pressure (BP) in the entire population. Having a usual source of care, optimizing adherence, and minimizing therapeutic inertia are associated with higher rates of BP control. The Chronic Care Model, a collaborative partnership among the patient, provider, and health system, incorporates a multilevel approach for control of hypertension. Optimizing the prevention, recognition, and care of hypertension requires a paradigm shift to team-based care and the use of strategies known to control BP.Item Open Access Racial differences in nocturnal dipping status in diabetic kidney disease: Results from the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study.(Journal of clinical hypertension (Greenwich, Conn.), 2017-12) Zullig, Leah L; Diamantidis, Clarissa J; Bosworth, Hayden B; Bhapkar, Manjushri V; Barnhart, Huiman; Oakes, Megan M; Pendergast, Jane F; Miller, Julie J; Patel, Uptal DWhile racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among participants with diabetic kidney disease enrolled in the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) trial. The primary outcome was nocturnal dipping-percent decrease in average systolic BP from wake to sleep-with categories defined as reverse dippers (decrease <0%), nondippers (0%-<10%), and dippers (≥10%). Twenty-four-hour ambulatory BP monitoring was completed by 108 participants (54% were nondippers, 24% were dippers, and 22% were reverse dippers). In adjusted models, the common odds of reverse dippers vs nondippers/dippers and reverse dippers/nondippers vs dippers was 2.6 (95% confidence interval, 1.2-5.8) times higher in blacks than in whites. Without ambulatory BP monitoring data, interventions that target BP in black patients may be unable to improve outcomes in this high-risk group.Item Open Access Racial differences in two self-management hypertension interventions.(The American journal of medicine, 2011-05) Bosworth, Hayden B; Olsen, Maren K; Grubber, Janet M; Powers, Benjamin J; Oddone, Eugene ZBackground
Only one half of Americans have their blood pressure controlled, and there are significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of 2 patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (African Americans, 49%).Methods
Post hoc analysis of a 2 by 2 randomized trial with 2-year follow-up in 2 university-affiliated primary care clinics was performed. Within white and non-white patients (n=634), 4 groups were examined: 1) usual care; 2) home blood pressure monitoring (3 times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; and 4) a combination of the 2 interventions.Results
The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, P=. 08; diastolic blood pressure, P=.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at 12 or 24 months for any intervention compared with the control group. At 12 months, the non-whites (n=328) in all 3 intervention groups had systolic blood pressure decreases of 5.3 to 5.7 mm Hg compared with usual care (P <.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure compared with usual care (7.5 mm Hg; P <.02). A similar pattern was observed for diastolic blood pressure.Conclusion
Combined home blood pressure monitoring and a tailored behavioral phone intervention seem to be particularly effective for improving blood pressure in non-white patients.Item Open Access Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD).(American heart journal, 2019-10) Okeke, Nwora Lance; Webel, Allison R; Bosworth, Hayden B; Aifah, Angela; Bloomfield, Gerald S; Choi, Emily W; Gonzales, Sarah; Hale, Sarah; Hileman, Corrilynn O; Lopez-Kidwell, Virginie; Muiruri, Charles; Oakes, Megan; Schexnayder, Julie; Smith, Valerie; Vedanthan, Rajesh; Longenecker, Chris TPersons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression.Item Open Access Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management.(Circulation. Cardiovascular quality and outcomes, 2011-03) Shah, Bimal R; Adams, Martha; Peterson, Eric D; Powers, Benjamin; Oddone, Eugene Z; Royal, Kira; McCant, Felicia; Grambow, Steven C; Lindquist, Jennifer; Bosworth, Hayden BBackground
Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors.Methods
To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors.Conclusion
If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00901277.Item Open Access Self-monitoring and self-titration of antihypertensive medication reduces systolic blood pressure compared with usual care.(Evidence-based nursing, 2015-07) Bosworth, Hayden B; Crowley, Matthew JItem Open Access Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis.(PLoS medicine, 2017-09) Tucker, Katherine L; Sheppard, James P; Stevens, Richard; Bosworth, Hayden B; Bove, Alfred; Bray, Emma P; Earle, Kenneth; George, Johnson; Godwin, Marshall; Green, Beverly B; Hebert, Paul; Hobbs, FD Richard; Kantola, Ilkka; Kerry, Sally M; Leiva, Alfonso; Magid, David J; Mant, Jonathan; Margolis, Karen L; McKinstry, Brian; McLaughlin, Mary Ann; Omboni, Stefano; Ogedegbe, Olugbenga; Parati, Gianfranco; Qamar, Nashat; Tabaei, Bahman P; Varis, Juha; Verberk, Willem J; Wakefield, Bonnie J; McManus, Richard JBackground
Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension.Methods and findings
Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (7,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (-3.2 mmHg, [95% CI -4.9, -1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg [-3.3, 1.2]), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic -0.2 mmHg [-2.2, 1.8]; ambulatory 1.1 mmHg [-0.3, 2.5]). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies.Conclusions
Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.Item Open Access Self-monitoring of Blood Pressure in Patients With Hypertension-Related Multi-morbidity: Systematic Review and Individual Patient Data Meta-analysis.(American journal of hypertension, 2020-03) Sheppard, JP; Tucker, KL; Davison, WJ; Stevens, R; Aekplakorn, W; Bosworth, HB; Bove, A; Earle, K; Godwin, M; Green, BB; Hebert, P; Heneghan, C; Hill, N; Hobbs, FDR; Kantola, I; Kerry, SM; Leiva, A; Magid, DJ; Mant, J; Margolis, KL; McKinstry, B; McLaughlin, MA; McNamara, K; Omboni, S; Ogedegbe, O; Parati, G; Varis, J; Verberk, WJ; Wakefield, BJ; McManus, RJBackground
Studies have shown that self-monitoring of blood pressure (BP) is effective when combined with co-interventions, but its efficacy varies in the presence of some co-morbidities. This study examined whether self-monitoring can reduce clinic BP in patients with hypertension-related co-morbidity.Methods
A systematic review was conducted of articles published in Medline, Embase, and the Cochrane Library up to January 2018. Randomized controlled trials of self-monitoring of BP were selected and individual patient data (IPD) were requested. Contributing studies were prospectively categorized by whether they examined a low/high-intensity co-intervention. Change in BP and likelihood of uncontrolled BP at 12 months were examined according to number and type of hypertension-related co-morbidity in a one-stage IPD meta-analysis.Results
A total of 22 trials were eligible, 16 of which were able to provide IPD for the primary outcome, including 6,522 (89%) participants with follow-up data. Self-monitoring was associated with reduced clinic systolic BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co-morbidities (-3.12 mm Hg, [95% confidence intervals -4.78, -1.46 mm Hg]; P value for interaction with number of morbidities = 0.260). Intense interventions were more effective than low-intensity interventions in patients with obesity (P < 0.001 for all outcomes), and possibly stroke (P < 0.004 for BP control outcome only), but this effect was not observed in patients with coronary heart disease, diabetes, or chronic kidney disease.Conclusions
Self-monitoring lowers BP regardless of the number of hypertension-related co-morbidities, but may only be effective in conditions such obesity or stroke when combined with high-intensity co-interventions.Item Open Access Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.(Contemporary clinical trials, 2018-06) Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal DDiabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m2, mean eGFR was 80.7 ml/min/1.73 m2, and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided.Trial registration
NCT01829256.Item Open Access The hypertension team: the role of the pharmacist, nurse, and teamwork in hypertension therapy.(Journal of clinical hypertension (Greenwich, Conn.), 2012-01) Carter, Barry L; Bosworth, Hayden B; Green, Beverly BTeam-based care is one of the key components of the patient-centered medical home. Studies have consistently demonstrated that teams involving pharmacists or nurses in patient management can significantly improve blood pressure control. These findings have been demonstrated in several meta-analyses and systematic reviews. These reviews have generally found that team-based care can reduce systolic blood pressure by 4-10 mm Hg over usual care. However, these reviews have also concluded that many of the studies had various limitations and that additional research should be conducted. The present state of the art review paper will highlight newer studies, many of which were funded by the National Institutes of Health. Newer strategies involve telephone and/or web-based management which is an evolving area to improve blood pressure control in large populations. Social media and other technology is currently being investigated to assist pharmacists or nurses in communicating with patients to improve hypertension management. Few cost-effectiveness analyses have been performed but generally have found favorable costs for team-based care when considering the potential to reduce morbidity and mortality. The authors will suggest additional research that needs to be conducted to help evaluate strategies to best implement team-based care to improve blood pressure management.Item Open Access The role of home blood pressure telemonitoring in managing hypertensive populations.(Current hypertension reports, 2013-08) Zullig, Leah L; Melnyk, S Dee; Goldstein, Karen; Shaw, Ryan J; Bosworth, Hayden BHypertension is a common chronic disease affecting nearly one-third of the United States population. Many interventions have been designed to help patients manage their hypertension. With the evolving climate of healthcare, rapidly developing technology, and emphasis on delivering patient-centered care, home-based blood pressure telemonitoring is a promising tool to help patients achieve optimal blood pressure (BP) control. Home-based blood pressure telemonitoring is associated with reductions in blood pressure values and increased patient satisfaction. However, additional research is needed to understand cost-effectiveness and long-term clinical outcomes of home-based BP monitoring. We review key interventional trials involving home based BP monitoring, with special emphasis placed on studies involving additionally behavioral modification and/or medication management. Furthermore, we discuss the role of home-based blood pressure telemonitoring within the context of the patient-centered medical home and the evolving role of technology.Item Open Access Treatment intensification in a hypertension telemanagement trial: clinical inertia or good clinical judgment?(Hypertension (Dallas, Tex. : 1979), 2011-10) Crowley, Matthew J; Smith, Valerie A; Olsen, Maren K; Danus, Susanne; Oddone, Eugene Z; Bosworth, Hayden B; Powers, Benjamin JClinical inertia represents a barrier to hypertension management. As part of a hypertension telemanagement trial designed to overcome clinical inertia, we evaluated study physician reactions to elevated home blood pressures. We studied 296 patients from the Hypertension Intervention Nurse Telemedicine Study who received telemonitoring and study physician medication management. When a patient's 2-week mean home blood pressure was elevated, an "intervention alert" prompted study physicians to consider treatment intensification. We examined treatment intensification rates and subsequent blood pressure control. Patients generated 1216 intervention alerts during the 18-month intervention. Of 922 eligible intervention alerts, study physicians intensified treatment in 374 (40.6%). Study physician perception that home blood pressure was acceptable was the most common rationale for nonintensification (53.7%). When "blood pressure acceptable" was the reason for not intensifying treatment, the mean blood pressure was lower than for intervention alerts where treatment intensification occurred (135.3/76.7 versus 143.2/80.6 mm Hg; P<0.0001). Blood pressure acceptable intervention alerts were associated with the lowest incidence of repeat alerts (hazard ratio: 0.69 [95% CI: 0.58 to 0.83]), meaning that the patient home blood pressure was less likely to subsequently rise above goal, despite apparent clinical inertia. This telemedicine intervention targeting clinical inertia did not guarantee treatment intensification in response to elevated home blood pressures. However, when physicians did not intensify treatment, it was because blood pressure was closer to an acceptable threshold, and repeat blood pressure elevations occurred less frequently. Failure to intensify treatment when home blood pressure is elevated may, at times, represent good clinical judgment, not clinical inertia.