The Take Control of Your Blood pressure (TCYB) study: study design and methodology

BACKGROUND: Among the 65 million Americans with hypertension, only approximately 31% have their blood pressure under control (<140/90 mm/Hg). Despite the damaging impact of hypertension and the availability of evidence-based target values for blood pressure, interventions to improve blood pressure control have had limited success. OBJECTIVES: A randomized controlled health services intervention trial with a two by two design is being conducted to improve blood pressure control. This five-year trial evaluates two patient-directed interventions designed to improve blood pressure control among patients diagnosed with hypertension in a community-based primary care setting. METHODS: Patients are randomized to one of four groups: usual care, home blood pressure monitoring, tailored behavioral self-management intervention that is administered via telephone by a nurse, or a combination of the home blood pressure monitoring and tailored behavioral intervention. Patients receiving the home blood pressure monitoring are trained in the use of an electronic blood pressure measurement device, are asked to measure their blood pressure 3 times/week, and send in two-month blood pressure recordings throughout the 24-month study duration. The behavioral intervention incorporates patients' need assessments and involves tailored behavioral and education modules to promote medication adherence and improve specific health behaviors. A nurse delivers all behavioral self-management modules over the telephone bi-monthly for 24 months. The primary outcome is the proportion of patients who achieve control of their blood pressure based on evidence-based guidelines (for patients without diabetes <140/90 mm/Hg, for patients with diabetes <130/80 mm/Hg) evaluated at six-month intervals over 24 months (five measurements) using a random-zero sphygmomanometer. CONCLUSION: Despite the known risk of poor blood pressure control, and the wide availability of effective treatment strategies, a majority of adults still do not have their blood pressure controlled. This study will be an important step in defining two explicit interventions to improve blood pressure control. To our knowledge, this study is the first to combine both a tailored behavioral self-management intervention and self-monitoring home blood pressure intervention to improve blood pressure control among patients in a primary care setting.     

Assessment of the association between blood pressure control and health care resource use.

BACKGROUND: Several studies have reported increased health care resource use among hypertensive patients with uncontrolled blood pressure (BP). OBJECTIVE: The purpose of this study was to investigate the relationship between BP control and health care resource use. METHODS: Data were obtained from the Caring for Hypertension on Initiation: Costs and Effectiveness (CHOICE) study, a multicenter feasibility study of actual physician and patient behavior and clinical outcomes in a naturalistic setting. Adult patients with newly diagnosed hypertension were randomized to either Group 1 (treatment with diuretics or beta-blockers) or Group 2 (treatment with calcium channel blockers or angiotensin-converting enzyme inhibitors) and followed for 5 +/- 1 months. Physicians practiced standard care while documenting medications, BP measurements, and health care resource use for their patients. A subsequent analysis evaluating the relationship between BP and physician visits was performed for the whole population and for a subpopulation of patients with at least 4 months of follow-up data. Cox regression was used to model time to next visit. RESULTS: A total of 512 patients with newly diagnosed hypertension were followed: 399 had follow-up data for at least 4 months. Baseline demographic characteristics were similar in the 2 groups. Kaplan-Meier curves and a log-rank test showed that the time to next visit for patients with uncontrolled BP was significantly shorter than for patients whose BP was controlled (P < 0.05). On average, patients with uncontrolled BP (> or = 140/90 mm Hg) had follow-up office visits approximately 13 days earlier than patients with controlled BP (< 140/90 mm Hg). This association remained significant after adjustment for repeated measures, and after exclusion of the first return visit. Cox regression analysis showed that higher systolic and diastolic BP measurements were significantly associated with a shorter time to next visit, after adjustment for age and sex. Total estimated costs during the study period were $170 per patient for medications and $283 per patient for office visits. CONCLUSIONS: In the CHOICE study, higher BP was associated with a shorter time to next visit. Office visits were the main cost driver in the short-term management of hypertension.     

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: A randomized clinical trial

BackgroundGiven their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking.Methods/designWe report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12 months.DiscussionResults from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control.     

A web-based patient activation intervention to improve hypertension care: Study design and baseline characteristics in the web hypertension study

BackgroundDespite the known health risks of hypertension, many hypertensive patients still have uncontrolled blood pressure. Clinical inertia, the tendency of physicians not to intensify treatment, is a common barrier in controlling chronic diseases. This trial is aimed at determining the impact of activating patients to ask providers to make changes to their care through tailored feedback.MethodsDiagnosed hypertensive patients were enrolled in this RCT and randomized to one of two study groups: (1) the intervention condition – Web-based hypertension feedback, based on the individual patient's self-report of health variables and previous BP measurements, to prompt them to ask questions during their next physician's visit about hypertension care (2) the control condition – Web-based preventive health feedback, based on the individual's self-report of receiving preventive care (e.g., pap testing), to prompt them to ask questions during their next physician's visit about preventive care. The primary outcome of the study is change in blood pressure and change in the percentage of patients in each group with controlled blood pressure.ConclusionFive hundred participants were enrolled and baseline characteristics include a mean age of 60.0 years; 57.6% female; and 77.6% white. Overall 37.7% participants had uncontrolled blood pressure; the mean body mass index (BMI) was in the obese range (32.4) and 21.8% had diabetes. By activating patients to become involved in their own care, we believe the addition of the web-based intervention will improve blood pressure control compared to a control group who receive web-based preventive messages unrelated to hypertension.     

Controlling blood pressure in 50% of all hypertensive patients: an achievable goal in the healthy people 2010 report?

BACKGROUND: One important objective defined in the Healthy People 2010 report was to improve blood pressure (BP) control to < 140/90 mm Hg in 50% of all hypertensive patients. Because the US population is becoming older, more obese, and ethnically diverse, the health and economic benefits of reaching this goal become more valuable each year. Hypertension control rates are currently at approximately 31% of all hypertensives and have risen slowly and erratically since 1988. In the absence of a coordinated strategic plan, achieving this critically important goal for BP control is highly unlikely. METHODS: A selected literature review was undertaken to briefly assess the cardiovascular benefits of controlling hypertension. Greater focus was placed on variables that impact hypertension awareness, treatment, and control. The impact on hypertension control rates of theoretic changes in awareness, treatment, and control individually and collectively was examined. Four categories of potential barriers to optimizing BP control are discussed: systems, provider, patient, and treatment factors. RESULTS: Raising awareness to 80% of all hypertensives, ensuring treatment of 90% of aware hypertensives, and controlling BP to < 140/90 mm Hg in 70% of treated patients would achieve control rates of 50%. CONCLUSIONS: The barriers to achieving the Healthy People 2010 goal of controlling hypertension in 50% of all patients are formidable but appear to be resolvable with a coordinated strategic plan. Given projected demographic changes in the United States, the health and economic benefits of attaining the national goal for hypertension control would seem to merit a serious integrated effort.     

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics

Despite 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 (≥ 140 mm Hg for non-diabetic or ≥ 130 mm Hg 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 12 months 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 63.5 years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6 mm Hg. 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.     

Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial

BackgroundPatients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension.ObjectivesThe Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care.MethodsHyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n = 222) and 8 were randomized to provide the telemonitoring intervention (TI) (n = 228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention.ConclusionsWe will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care.     

Primary Care–based,Pharmacist–physician Collaborative Medication-therapy Management of Hypertension: A Randomized,Pragmatic Trial

Purpose

A collaborative pharmacist–primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensive patients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic.

Methods

This randomized, pragmatic clinical trial was conducted in hypertensive patients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥140/≥90 mm Hg (≥130/≥80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol.

Findings

A total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (–7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (–5.2 [16.9] vs –1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001).

Implications

A PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556.     

Strengthening patient-provider relationships

In support of the Veterans Health Administration commitment to the promotion of shared decision-making between providers and patients, this study investigated the relationship between the provision of a patient appointment guidebook, designed to promote and support patient participation in the health care visit, and patient perceptions of primary care visit effectiveness. This study compared perceptions among 277 randomly selected patients randomly assigned to one of two groups. Patients assigned to an intervention group received a patient appointment guidebook along with the standard appointment reminder letter prior to the scheduled routine visit. Patients assigned to a control group received only the standard appointment reminder letter. Patient perceptions were assessed with a follow-up questionnaire designed to measure patient agreement with six statements pertaining to primary care visit effectiveness. No significant differences were noted in the proportion of patients in the two groups that agreed with any of the six statements pertaining to primary care visit effectiveness. Significant differences were noted, however, in the proportion of patients in the groups who received preventive health care interventions of influenza vaccination, pneumococcal vaccination, and gender-specific cancer screening. Approximately 37% of the patients in the intervention group provided positive comments about the patient appointment guidebook, while only 7% provided negative comments. Although statistically inconclusive, the narrative comments indicate that a patient appointment guidebook may assist veterans in preparing for primary care appointments. The lack of significant difference between the two groups on the measures of primary care visit effectiveness may be due, in part, to positive perceptions among the sample in general, as reflected by high levels of agreement and predominantly positive comments for both control and intervention groups.     

PRODIACOR: a patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: study design and baseline data

OBJECTIVE: To implement a controlled clinical trial (PRODIACOR) in a primary care setting designed 1) to improve type 2 diabetes care and 2) to collect cost data in order to be able to measure cost-effectiveness of three system interventions (checkbook of indicated procedures, patient/provider feedback and complete coverage of medications and supplies) and physician and/or patient education to improve psychological, clinical, metabolic and therapeutic indicators. All three Argentinean health subsectors (public health, social security and the private, prepaid system) are participants in the study. Patients of participating physicians were randomly selected and assigned to one of four groups: control, provider education, patient education, and provider/patient education; the system interventions were provided to all four groups. BASELINE RESULTS: Mean BMI was 29.8 kg/m(2); most subjects had blood pressure, fasting glucose and total cholesterol above targets recommended by international standards. Only 1% had had microalbuminuria measured, 57% performed glucose self-monitoring, 37% had had an eye examination and 31% a foot examination in the preceding year. Ten percent, 26% and 73% of people with hyperglycemia, hypertension and dyslipidemia, respectively, were not on medications. Most patients treated with either insulin or oral antidiabetic agents were on monotherapy as were those treated for hypertension and dyslipidemia. WHO-5 questionnaire scores indicated that 13% of the subjects needed psychological intervention. CONCLUSIONS: Baseline data show multiple deficiencies in the process and outcomes of care that could be targeted and improved by PRODIACOR intervention.     

Pharmacist intervention program for control of hypertension

BACKGROUND: Pharmaceutical care programs have been shown to improve outcomes in hypertension. However, most programs required direct access to patient medical chart and patient consultation sessions by appointment. OBJECTIVE: To follow the current practice of community pharmacy, exploring the effect of an intervention program on blood pressure (BP) and factors affecting BP. METHODS: Treated hypertensive patients were enrolled in a 9-month controlled study involving 9 community pharmacies. The PRECEDE-PROCEED model was used as conceptual framework to identify factors affecting BP, to incorporate those factors in an intervention program, and to evaluate the impact of the program. A computerized decision-aid tool was used by pharmacists from 4 pharmacies to provide pharmaceutical care to subjects (n = 41); pharmacists from the 5 other pharmacies performed usual care (n = 59). As there was a statistically significant interaction due to family income in describing the impact of pharmacists' intervention on BP, population was stratified by family income in the analyses. RESULTS: Compared with the control group, the pharmacy program resulted in significant systolic BP reduction (-7.8 vs. 0.5 mm Hg; p = 0.01) and an increase in the proportion of controlled patients only for those with high incomes. In the high-income group, the program also had a positive impact on physical activity, self-reported adherence, health concerns, and information transmitted. The low-income group did not appear to benefit from the program. CONCLUSIONS: Pharmacist intervention can modify factors affecting adherence, improve adherence, and reduce BP levels in patients treated with antihypertensive agents. Impact of pharmacist intervention on BP differed according to patient income status.     

Shake Rattle & Roll – Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension

BackgroundIn Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control.MethodsSRR was a cluster randomized controlled trial conducted at an urban medical center. All 98 adult primary care physicians (PCP) and their panels of hypertensive black patients were randomized, stratified by panel size, to one of three arms: 1) Usual Care (n = 33 PCPs, N = 1129 patients); 2) Enhanced Monitoring arm with an emphasis on improving pharmacotherapy protocol adherence (n = 34 PCPs, N = 349 patients); or 3) Lifestyle arm with a culturally tailored diet and lifestyle coaching intervention focusing on the Dietary Approaches to Stop Hypertension eating plan (n = 31 PCPs, N = 286 patients). The intervention period was for 12-months post-enrollment. Follow-up was planned for one and three years post-intervention completion. Primary outcome measure was the proportion of participants with controlled BP, defined as <140/90 mmHg, at 12-months post-enrollment. Secondary outcome included adverse cardiovascular events. An intention-to-treat analysis was carried out as the primary analysis.ConclusionSRR was a uniquely designed trial that included components from both pragmatic and explanatory methods. The pragmatic aspects allow for a more cost-effective way to conduct a clinical trial and easier implementation of successful interventions into clinical practice. However, there were also challenges of having mixed methodology with regards to trial conduction and analysis.     

Clinical experience with transdermal clonidine in African-American and Hispanic-American patients with hypertension: evaluation from a 12-week prospective, open-label clinical trial in community-based clinics.

The objective of this study was to assess the efficacy and tolerability of transdermal clonidine in inner-city African-American and Hispanic-American patients with essential hypertension. A multiclinic open-label, prospective trial for 12 weeks was used. Dose titration was based on office blood pressure (BP) measurements of > 140/90 mm Hg. Clinical sites were community-based primary care centers. Untreated and treated hypertensive patients whose diastolic BP exceeded 90 mm Hg were administered transdermal clonidine at 0.1 mg or 0.2 mg delivery daily. The drug was titrated after 1 month if diastolic BP was greater than 90 mm Hg. At 12 weeks of treatment, change in blood pressure from baseline as well as adverse effects and patient satisfaction were assessed. A total of 357 patients entered the treatment phase of the study, and 315 patients (244 African-Americans, 67 Hispanic-Americans) had evaluable data. Transdermal clonidine significantly (P <.001) lowered BP in all patients by 15.7/12.8 +/- 18.1/9.6 mm Hg, and heart rate was reduced by 3 +/- 9 beats/min (P <.001). There were no differences in BP reduction according to race and ethnicity, gender, or age. The most common adverse effects were pruritus or discomfort at the patch site, dizziness, dry mouth, and fatigue. Eleven percent of the patients discontinued treatment because of one of these adverse effects. A large proportion of patients (67%) reported that transdermal clonidine was more convenient to use than oral therapy. Transdermal clonidine, alone or in combination with other antihypertensive therapies, significantly lowered BP and heart rate in inner-city hypertensive patients. The drug was generally well tolerated, with 89% of the patients remaining in the trial. Patient acceptability was high with the once-weekly treatment, which is an important feature for this particular hypertensive population.     

Tool to improve patient-provider interactions in adult primary care: Randomized controlled pilot study

ObjectiveTo assess whether an intervention to help patients prioritize goals for their visit would improve patient-provider communication and clinical outcomes.DesignRandomized controlled pilot study.SettingPrimary care clinic.ParticipantsThere were 120 adult hypertensive patients enrolled.InterventionPatients were randomized to receive either usual care or a previsit patient activation card developed through a series of focus groups that prompted patients to articulate their needs and set priorities for their clinic visit. Encounters were audiorecorded, transcribed, and assessed using duplicate ratings of patient activation and decision making.Main outcome measuresThe primary outcome was change in medication adherence as measured by pill count at 4 and 12 weeks after the initial visit. Secondary outcomes evaluated patient-provider interaction quality (patient satisfaction, patient activation, shared decision making, patient trust, and physicians’ perceived difficulty of the encounter), functional status, and blood pressure control.ResultsOf the 120 enrolled patients, 106 completed the baseline visit (mean age of 66 years, 53% women, 57% Black, 36% White). Participants had multiple comorbidities (median number of medications = 8). During the visit, there was greater patient activation in the intervention arm than in the control arm (4.4 vs 3.8, P = .047; ratings were based on a scale from 1 to 10). However, after the visit there were no differences in medication adherence (4 weeks: 45.8% vs 49.5%; 12 weeks: 49.4% vs 51.1%), blood pressure control (4 weeks: 133/78 mm Hg vs 131/77 mm Hg; 12 weeks: 129/77 mm Hg vs 129/76 mm Hg), or encounter satisfaction (78.6% vs 73.8% fully satisfied; P = .63). There were also no differences in shared decision making, patients’ trust, or perceived difficulty of the encounter.ConclusionA single previsit tool designed to prompt patients to set a prioritized agenda improved patient activation during the visit, but did not affect the quality of the interaction or postvisit patient-centred outcomes.     

Pharmacist involvement in primary care improves hypertensive patient clinical outcomes

BACKGROUND: The practice of pharmaceutical care in primary care settings in Thailand is currently not generally accepted. OBJECTIVE: To evaluate the effect of pharmacist involvement in treatment with hypertensive patients in primary care settings. METHODS: The treatment objective was to stabilize the blood pressure (BP) of hypertensive patients in accordance with the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. Patients were randomly assigned to a pharmacist-involved group (treatment) or a group with no pharmacist involvement (control). Pre- and post-test BPs, tablet counts, lifestyle modifications, and pharmacists' recommendations were recorded. The 6-month study was carried out in Mahasarakham University pharmacy and 2 primary care units. Patients were monitored monthly by reviewing their medications and supported by providing pharmaceutical care and counseling. RESULTS: From a total of 235 patients, the treatment group (n = 118) had a significant reduction in both systolic (S) and diastolic (D) BP compared with the 117 patients of the control group (p = 0.037, 0.027, respectively). The 158 patients (76 treatment, 82 control) with BPs >or=140/90 mm Hg at the beginning of the study showed significant BP reductions (p = 0.002 SBP, 0.008 DBP). The proportion of 158 patients whose BP became stabilized was higher in the treatment group (p = 0.017). The treatment group showed significantly better adherence (p = 0.014) and exercise control (p = 0.012) at the end of the study. Physicians accepted 42.72% of medication modifications and 5.34% of the suggestions for additional investigations. CONCLUSIONS: Hypertensive patients who received pharmacist input achieved a significantly greater benefit in BP reduction, BP control, and improvement in adherence rate and lifestyle modification.     

Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial

OBJECTIVE

To determine whether nurse case management with a therapeutic algorithm could effectively improve rates of control for hypertension, hyperglycemia, and hyperlipidemia compared with usual care among veterans with diabetes.

RESEARCH DESIGN AND METHODS

A randomized controlled trial of diabetic patients that had blood pressure (BP) >140/90 mmHg, hemoglobin A_1c (HbA_1c) >9.0%, or LDL >100 mg/dL. Intervention patients received case management (n = 278) versus usual care (n = 278) over a 1-year period. The primary outcome was the percentage of patients achieving simultaneous control of all three parameters (defined by BP <130/80 mmHg, HbA_1c <8.0%, and LDL <100 mg/dL) at 1 year. Secondary outcomes included improvements within each individual component of the composite primary outcome. Differences between groups were analyzed using t tests, Pearson χ² tests, and linear and logistic regression.

RESULTS

A greater number of individuals assigned to case management achieved the primary study outcome of having all three outcome measures under control (61 [21.9%] compared with 28 [10.1%] in the usual care group [P < 0.01]). In addition, a greater number of individuals assigned to the intervention group achieved the individual treatment goals of HbA_1c <8.0% (73.7 vs. 65.8%, P = 0.04) and BP <130/80 mmHg (45.0 vs. 25.4%, P < 0.01), but not for LDL <100 mg/dL (57.6 vs. 55.4%, P = 0.61), compared with those in the usual care group.

CONCLUSIONS

In patients with diabetes, nurse case managers using a treatment algorithm can effectively improve the number of individuals with control of multiple cardiovascular risk factors at 1 year.Cardiovascular risk factors are common and poorly controlled in patients with diabetes (1). Recent data from the National Health and Nutrition Examination Survey (NHANES) 2003–2006 suggest that only 12.2% of individuals with diabetes achieve simultaneous control of their blood pressure (BP), glycemia, and lipids. A method that has previously been used to improve risk factor control is case management using physician extenders (nurses, pharmacists, etc.) (2). Previous studies have attempted to improve control of an isolated risk factor such as glycemia or BP. We aimed to determine in a randomized controlled trial whether nurse case management could effectively improve simultaneous rates of control for hypertension, hyperglycemia, and hyperlipidemia compared with usual care among veterans with diabetes.     

Impact of a workplace stress reduction program on blood pressure and emotional health in hypertensive employees

OBJECTIVES: This study examined the impact of a workplace-based stress management program on blood pressure (BP), emotional health, and workplace-related measures in hypertensive employees of a global information technology company. DESIGN: Thirty-eight (38) employees with hypertension were randomly assigned to a treatment group that received the stress-reduction intervention or a waiting control group that received no intervention during the study period. The treatment group participated in a 16-hour program, which included instruction in positive emotion refocusing and emotional restructuring techniques intended to reduce sympathetic nervous system arousal, stress, and negative affect, increase positive affect, and improve performance. Learning and practice of the techniques was enhanced by heart rate variability feedback, which helped participants learn to self-generate physiological coherence, a beneficial physiologic mode associated with increased heart rhythm coherence, physiologic entrainment, parasympathetic activity, and vascular resonance. BP, emotional health, and workplace-related measures were assessed before and 3 months after the program. RESULTS: Three months post-intervention, the treatment group exhibited a mean adjusted reduction of 10.6 mm Hg in systolic BP and of 6.3 mm Hg in diastolic BP. The reduction in systolic BP was significant in relation to the control group. The treatment group also demonstrated improvements in emotional health, including significant reductions in stress symptoms, depression, and global psychological distress and significant increases in peacefulness and positive outlook. Reduced systolic BP was correlated with reduced stress symptoms. Furthermore, the trained employees demonstrated significant increases in the work-related scales of workplace satisfaction and value of contribution. CONCLUSIONS: Results suggest that a brief workplace stress management intervention can produce clinically significant reductions in BP and improve emotional health among hypertensive employees. Implications are that such interventions may produce a healthier and more productive workforce, enhancing performance and reducing losses to the organization resulting from cognitive decline, illness, and premature mortality.     

Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban African Americans

BACKGROUND: Nearly one in three adults in the United States has hypertension. Hypertension is one of the largest risk factors for cardiovascular diseases, and it is growing in prevalence, especially among African Americans. OBJECTIVES: To test the hypothesis that individuals who participate in usual care (UC) plus blood pressure (BP) telemonitoring (TM) will have a greater reduction in BP from baseline to 12-month follow-up than would individuals who receive UC only. METHODS: A two-group, experimental, longitudinal design with block stratified randomization for antihypertensive medication use was used. African Americans with hypertension were recruited through free BP screenings offered in the community. Data were collected through a structured interview and brief physical exam. Cross tabs, repeated measures analysis of variance, and independent t tests were used to analyze the study's hypothesis. RESULTS: The TM intervention group had a greater reduction in systolic BP (13.0 mm Hg) than the enhanced UC group (7.5 mm Hg; t = -2.09, p = .04) from baseline to the 12-month follow-up. Although the TM intervention group had a greater reduction in diastolic BP (6.3 mm Hg) compared with the enhanced UC group (4.1 mm Hg), the differences were not statistically significant (t = -1.56, p = .12). DISCUSSION:: Telemonitoring of BP resulted in clinically and statistically significant reductions in systolic BP over a 12-month period; if maintained over a longer period of time, the reductions could improve care and outcomes significantly for African Americans with hypertension.