Although blood pressure (BP) control has improved substantially in the last five decades, only half of the United States population with hypertension have adequate BP control. In contrast, BP control in some high-performing health systems is much better and can be as high as 80% to 90%. The strategies used by these high-performing systems may help other providers to improve BP control within their offices or health care settings.
There are many causes for poor BP control besides lifestyle choices, including suboptimal patient medication adherence and failure to intensify therapy (clinical inertia) by clinicians. Clinical inertia occurs when physicians do not intensify antihypertensives, perhaps because of concern about the predictive value or accuracy of clinic BP measurements, BP that was close to, but not at or below, goal, patient resistance to adding medications, lower home BP measurements, suspected white-coat hypertension, more urgent competing medical problems, or the patient stating they are experiencing more stress on the day of the clinic visit. However, many of these barriers could be overcome if the organizational structure of health care delivery adequately supported physicians and patients ( Fig. 48.1 ).
Many quality improvement strategies have been tried to improve BP including patient education, reminders, physician alerts, and others. Most of these had modest effects, with the exception of team-based care, which was the most effective strategy to improve BP.
The Patient-Centered Medical Home
The patient-centered medical home (PCMH) has been promoted to minimize episodic care, improve continuity, and provide more comprehensive management of chronic illness and preventive care. The PCMH was developed and endorsed by the American Academy of Family Physicians, American Academy Pediatrics, American College of Physicians, and is now a major component of Accountable Care Organizations within health care reform as a strategy to improve care quality at lower costs. The National Committee on Quality Assurance (NCQA) has developed standards and provided formal recognition of health plans and individual providers for many years. NCQA revised the standards to score health systems in 2014 ( Table 48.1 ). Although previous standards supported team-based care, the 2014 standards made team care an essential component of the PCMH by including it as one of the six key standards. Health systems that want to achieve the highest level (level 3, Table 48.1 ) of PCMH recognition must have well-functioning health care teams because this component is responsible for 20% of the total score. In addition, care management, medication management, care coordination, and coordination of care transitions are all functions typically performed by nonphysicians and make up another 14% of the score ( Table 48.1 ).
| Standard 1: Enhance Access and Continuity | Points | Standard 4: Plan and Manage Care | |
| Points 4.5 3.5 2 10 |
| 4 4 4 3 5 20 |
| Standard 2: Team-Based Care | Standard 5: Track and Coordinate Care | ||
| 3 2.5 2.5 4 12 |
| 6 6 6 18 |
| Standard 3: Population Health Management | Standard 6: Measure and Improve Performance | ||
| 3 4 4 5 4 20 |
| 3 3 4 4 3 3 0 20 |
| Scoring Levels | |||
| |||
The standards also require medication reconciliation across health systems (e.g., between inpatient and primary care) for more than 80% of patients, families, and caregivers, providing information about new prescriptions to more than 80% of patients, assessing medications and barriers to adherence for more than 50% of patients, and documenting over-the-counter medications, herbal therapies, and supplements for more than 50% of patients.
The PCMH emphasizes that care should be organized around the needs of the patient, their relationship with their personal physician, and that physician-led teams assist with care according to the needs of the patient. The standards do not dictate who is on the team or how the team functions and communicates. However, the highest performing health systems have nurses, pharmacists, and behavioral health professions (e.g., counselors), and other critical members on this team. The physician delegates responsibility to other members of the team to perform a medication history, identify problems and barriers to achieving disease control, perform counseling on lifestyle modification, and adjust medications following hypertension guidelines. Frequent communication by team members concerning goal-directed therapy allows the physician to address more acute problems and complications. There is early evidence that the PCMH can be used to improve health care outcomes, increase physician satisfaction, and decrease the costs of health care. The personal relationship between the patient, physician, and the team has also been used to overcome barriers to care often seen in minorities or other vulnerable populations (see later).
Providers might assume that the PCMH standards apply only to those in typical primary care settings. However, the Referral Tracking and Follow-up standard 5B requires that providers have established agreements and criteria for specialists and the specialist be given the clinical question and type of referral. NCQA maintains a directory of specialists who have been recognized by NCQA as meeting the standards. Therefore, hypertension specialists and primary care providers who wish to become members of health systems and accountable care organizations will increasingly need to meet these standards.
The challenges of managing chronic conditions have led to strategies to provide care management, previously termed disease-state management. These programs usually focused on a given condition, such as hypertension. The PCMH demands more comprehensive programs that manage multiple conditions such as diabetes, dyslipidemia, hypertension, smoking cessation, and weight management, in an attempt to provide cardiac risk reduction. Large health systems may provide population-based strategies to target these patients, identify gaps in care, and guide these patients to programs that improve care. Smaller offices or clinics frequently do not have the resources to provide these comprehensive services because physicians are overworked and the offices do not have resources to hire key team members. Our research team is studying the effect of a centralized cardiovascular risk service in two clinical trials that can provide remote clinical pharmacy services to private physician offices and even patients in rural areas (see later).
Team-Based Care of Hypertension
Systematic Reviews
Care management within the PCMH emphasizes changes in health care delivery, self-management support, clinical information systems, delivery system redesign, decision support, health care organization, and community resources. One of the most studied areas of system redesign, or organizational change, is the inclusion of pharmacists or nurses as members of the health care team.
Walsh and colleagues evaluated 63 controlled studies using various quality improvement strategies to improve BP control such as patient education, physician reminders, or other approaches. These investigators found that the only statistically significant improvement in BP occurred with organizational change, which included team-based care (37 comparisons), and resulted in a median reduction in systolic BP (SBP) of 9.7 mm Hg and a 21.8% net increase in SBP control. Another meta-analysis of pharmacy based-interventions evaluated 13 studies that included 2200 individuals and found that pharmacists’ interventions significantly reduced SBP (10.7 ± 11.6 mm Hg; p = 0.002), whereas controls remained unchanged. A meta-analysis evaluated 39 randomized controlled trials in 14,224 patients and found pharmacist interventions reduced SBP by 7.6 mm Hg (95% confidence interval [CI]: −9.0 to −6.3 mm Hg) compared with usual care.
A meta-analysis evaluated 37 controlled clinical trials that involved either pharmacist or nurse case management of hypertension. The type of practitioner and training varied considerably. Although the Pharm.D degree is the only professional degree now awarded in pharmacy, at the time many of these studies were conducted, some pharmacists had a Bachelor of Science degree. Most studies that specified qualifications for nurses involved registered nurses (RN) or nurse practitioners. Nearly all studies involving nurses or pharmacists embedded within clinics provided for dedicated case management activities. Community pharmacists, however, usually had to incorporate the intervention within traditional medication dispensing functions. One goal of this meta-analysis was to evaluate the potency of individual components of team-based care interventions ( Table 48.2 ). The most effective strategies to reduce SBP were when the pharmacist made treatment recommendations to the physician (−9.3 mm Hg), the nurse or pharmacist educated the patient about their medications (−8.75 mm Hg), the pharmacists made the medication intervention changes (−8.44 mm Hg), medication adherence was assessed and addressed by the pharmacist or nurse (−7.9 mm Hg), counseling about lifestyle modification was performed (−7.59 mm Hg), or the nurse made the medication intervention changes (−4.8 mm Hg). When we examined the odds ratios for controlled BP with either nurses, pharmacists in clinics, or community pharmacists, all three types of interventions were significant ( Table 48.3 ), although the pharmacy interventions appeared to be more potent.
| Type of Individual Intervention | Median Reduction in Systolic Blood Pressure (Mm Hg) | Median Reduction in Diastolic Blood Pressure (Mm Hg) |
|---|---|---|
| Pharmacist made treatment recommendation to physician | −9.30 a | −3.60 |
| Patient education provided | −8.75 b | −3.60 b |
| Pharmacist conducted the medication intervention | −8.44 | −3.30 |
| Medication adherence assessed and addressed | −7.90 | −3.25 |
| Provided lifestyle modification counseling | −7.59 | −3.30 |
| Nurse conducted the medication intervention | −4.80 a | −3.10 |
b p < 0.05 for Mann-Whitney analysis of reduction in systolic blood pressure and diastolic blood pressure comparing studies with the specific intervention strategy with those without it.
| Type of Care Management | Odds Ratio | 95% Confidence Interval |
|---|---|---|
| Interventions by nurses | 1.69 | 1.48-1.93 |
| Interventions by pharmacists within clinics a | 2.48 | 2.05-2.99 |
| Interventions by pharmacists within community pharmacies | 2.89 a | 1.83-4.55 a |
a Includes an additional study in 410 patients published after the meta-analysis was published from Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med . 2009;169:1996-2002.
A meta-analysis of nurse-led interventions with treatment algorithms showed greater reductions in SBP (−8.2 mm Hg, 95% CI −11.5 to −4.9) compared with usual care but no difference in BP control. When results were pooled, nurse interventions significantly lowered SBP compared with usual care in African Americans but there was little difference for other ethnic minority groups.
The Community Prevention Services Task Force conducted a systematic review of team-based care in 2014. The study evaluated 52 international studies involving pharmacists and nurses and 41% of the trials involved a majority of African Americans. BP control was improved by a median of 12 percentage points (interquartile interval [IQI] 3.2, 20.8), SBP 5.4 mm Hg (2.0, 7.2) and diastolic blood pressure (DBP) 1.8 mm Hg (0.7, 3.2). The percent improvement in BP control was “considerably higher” when pharmacists were added (22.0%), compared with nurses (8.5%) or nurses plus pharmacists (16.2%). The improvement was much greater when the team member could make independent changes (17.4%) compared with those that required PCP approval (15.0) or support only (7.9%).
Cost-Effectiveness Analyses
Until recently, few cost-effectiveness studies had been conducted but several studies have now assessed the cost-to-benefit ratio of team-based care. Total costs for the pharmacist-managed group were similar to those in the physician-managed clinic group ($242.46 versus $233.20, p = 0.71), but cost effectiveness ratios were lower in the pharmacist-managed group ($27 versus $193/mm Hg for SBP readings, and $48 versus $151/mm Hg for DBP readings). The authors concluded that pharmacist management was cost effective.
We evaluated the cost of a 6-month intervention by pharmacists embedded within primary care clinics from two clinical trials involving 496 subjects. Total adjusted costs were $775 in the intervention group and $446 in the control group (difference $329.16, p < 0.001). Total costs between the two groups ranged from $224 to $516 with a sensitivity analysis. The cost to lower SBP 1 mm Hg was $36.
We conducted the Collaboration Among Pharmacist and Physicians to Improve Blood Pressure Now (CAPTION) trial that randomized 625 patients from 32 medical offices in 15 states. Each office had an existing clinical pharmacist on staff. Cost-effectiveness ratios were calculated based on changes in BP measurements and hypertension control rates. Thirty-eight percent of patients were African American, 14% were Hispanic, and 49% had annual income less than $25 000. At 9 months, average SBP was 6.1 mm Hg lower (±3.5), DBP was 2.9 mm Hg lower (±1.9) in the intervention group compared with the control group. Total costs for the intervention group were $1462.87 (±132.51) and $1259.94 (±183.30) for the control group, a difference of $202.93. The cost to lower BP by 1 mm Hg was $33.27 for SBP. The cost to increase the rate of hypertension control by 1 percentage point in the study population was $23.
The Community Prevention Services Task Force evaluated costs of team-based care. They determined that the cost to provide either a nurse or pharmacist intervention was $198 per year. The cost to reduce SBP 1 mm Hg was $87 which is much higher than our cost analyses in the two studies above. However, when these authors examined the 20-year cost per quality-adjusted life years (QALY) gained, the cost for the nurse intervention was $16,696 to $24,042 whereas it was $7,114 to $10,244 for pharmacists and “other.”
Nurse Case Management of Hypertension
Nurse case management has been an effective strategy to improve cardiovascular risk factors including BP. Nurses have assisted physicians by adhering more strictly to treatment algorithms and counseling that busy physicians have difficulty incorporating into an office visit.
One of the earliest studies of nurses was conducted in the work site and compared a nurse-managed group to a control group managed by the patient’s family physician. Nurses prescribed and changed drug therapy without physician approval while physicians reviewed the charts of nurse-managed patients on a weekly basis. The study involved 457 subjects and nurse-managed patients were more likely to receive a new antihypertensive (95% versus 63%, p < 0.001), receive two antihypertensives (44% versus 18%, p < 0.001), adhere to the medication regimen (68% versus 49%, p < 0.005), and achieve goal BP at 6 months (49% versus 28%, p < 0.001).
Another study evaluated care of several conditions including hypertension delivered by nurse practitioners compared with physicians. Most patients were Hispanic immigrants and all were enrolled after an emergency department or urgent care visit. Patients were randomized to either a nurse practitioner (n = 806) or a physician (n = 510). BP was slightly better when provided by nurse practitioners compared with physicians (137/82 versus 139/85 mm Hg, p = 0.28 for SBP and p = 0.04 for DBP) following a 12-month intervention.
The use of nurses to provide case management of hypertension has been well described over the past 40 years and has included mobile clinics, home visits, work-based programs, and clinic settings. Rudd and colleagues studied nurse case management of hypertension in a randomized controlled trial, in which 76 subjects were managed by their usual physician, and 74 received nurse-based care. At baseline, nurse case managers provided education regarding use of an automated BP device, strategies to improve medication adherence, and identification of adverse drug events. The nurses then conducted telephone interviews at 1 week and at 1, 2, and 4 months, for an average of 10 minutes per telephone call. The nurse independently made medication dosage increases but contacted the physician before initiating new BP medication. Systolic BP declined by 14.2 mm Hg in the intervention group compared only to 5.7 mm Hg in the control group ( p < 0.01) after 6 months, and significantly more medications were taken and significantly more medication changes (223 versus 52, p < 0.01) had been made in the intervention group than the control group.
Thus, some studies have found that nurse management can lead to improved BP control whereas others found BP was similar to usual care or that provided by physicians. These seemingly diverse findings are likely explained by important principles indicating the benefits of focused care. Nurse practitioners with a broad scope of practice and who care for a wide variety of patients achieve similar BP control rates as physicians. However, when nurse case managers are carefully integrated into a practice setting, focus on hypertension, are given responsibility for achieving BP goals and making medication modifications, BP control rates can be improved.
Use of Pharmacists in Team-Based Care of Hypertension
Pharmacists now practice in many different settings including physician office practices, academic primary care clinics and Veterans’ Affairs Medical Centers (VAMCs), and community pharmacies. Pharmacists in all these environments have assisted physicians with managing patients with hypertension. However, changes in state and federal law, especially the new Medicare prescription drug benefit, have established mechanisms by which pharmacists can bill for services. These changes may increase the ability of group practices to hire clinical pharmacists to assist with managing patients with hypertension.
Community Pharmacy
Community pharmacists have assisted with hypertension management in a number of ways, including screening and referral, education on lifestyle modifications, and monitoring medication adherence. The primary goal of these programs is to assist the physician with monitoring of BP in the patient’s community environment. Collaboration between physicians and community pharmacists can be challenging because of distance between providers and limited accessibility of data from medical records to community pharmacists. However, these barriers can be overcome if the physician and pharmacist establish formal policies and procedures regarding patient treatment. These policies and procedures should include goals of therapy, physician preference for the initiation of care plans including whether the pharmacist can initiate new therapies or change dosages, whether medication changes are via protocol or with physician consent, and when to triage or refer patients back to the physician, especially those patients with urgent needs (e.g., new onset of symptoms). These pharmacists need access to coexisting conditions, diagnostic information, and laboratory results. The issue of patient information transfer can be handled several ways. In some cases, patients simply sign a release of medical information and this document is sent to the patient’s physician. Pharmacists then frequently communicate with the physician via facsimile and/or with written notes and recommendations mailed to the physician. More recently, physicians have provided collaborating pharmacies with access to the electronic medical record (EMR) following appropriate certification including the Health Insurance Portability and Accountability Act (HIPAA) to allow access to their medical record information. In these cases, pharmacists can make recommendations to change medications directly into the EMR, thus making changes occur much more quickly and reliably.
Another classic study was published in Circulation in 1973 in 50 patients randomized to traditional pharmacy services or an intervention group. The community pharmacist worked closely with two physicians in an urban health center in Detroit, visited the physician’s office to review medical records, and made recommendations for changes in therapy. Patients in the intervention group were seen monthly for 5 months by appointment with the pharmacist in 1 of 3 community pharmacies participating in the study. BP in the physician’s office increased in the control group (163/93 versus 166/101 mm Hg) but was lowered in the intervention group (157/99 versus 146/90 mm Hg). The difference between the two groups was significant ( p < 0.001). Once the intervention was discontinued, BP control and adherence declined in the intervention group.
Zillich et al conducted a randomized trial in 12 community pharmacies that were randomized to a high-intensity (n = 64 patients) versus low-intensity intervention (n = 61 patients). The high-intensity intervention involved four face-to-face visits with a trained community pharmacist who provided patient-specific education about hypertension and recommendations to physicians. Following the first and third visits, patients were given a home BP monitoring device to measure their BP at least once daily for the next month. Home BP readings were used by the pharmacists to develop treatment recommendations for the patient’s physician. Recommendations were discussed with the physician and, if approved, implemented by the pharmacist. Patients in the low intervention group had their BP measured by the pharmacists and were then referred to their physician for evaluation if the BP was high. SBP declined 13.4 mm Hg in the high-intensity group and 9.0 mm Hg in the low-intensity group. At the final visit, the difference in SBP/DBP change between the high- and low-intensity groups was −4.5/−3.2 mm Hg ( p = 0.12 for SBP and p = 0.03 for DBP). This is one of the few pharmacy-based studies that found minimal differences between groups. The authors speculated that the large drop in BP in the low-intensity group may have been attributed to the simple act of having the community pharmacists measure the BP and refer patients back to their physician when BP was high. The marked reduction seen in the low intensity group reduced the effect size and power of the trial and led to a lack of statistical significance between groups.
Pharmacists Embedded Within Clinics
Pharmacist-managed hypertension clinics are found in specific settings such as VAMCs or academic health sciences centers. In such settings, pharmacists provide all the patient follow-up and medication changes but any changes were “staffed” with an internist. In other settings with specific protocols and scope of practice descriptions for pharmacists in a VAMC, pharmacists modify medications independently.
A study at Group Health in Seattle enrolled 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Participants were randomly assigned to usual care, home BP monitoring, and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered for 12 months through Web communications. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients at goal BP (<140/90 mm Hg) compared with usual care (36% [95% CI, 30% to 42%] versus 31% [95% CI, 25% to 37%]; p = 0.21). Adding Web-based pharmacist care significantly increased the percentage of patients who were at goal BP (56%; 95% CI, 49% to 62%) compared with usual care (31%; 95% CI, 25% to 37%; p < 0.001) and home BP monitoring and Web training only (36%; 95% CI, 30% to 42%; p < 0.001). The authors concluded that pharmacist care management was necessary to improve BP control when delivered through a secure website.
Most chronic care management services for hypertension provided by pharmacists are performed in group practices and in close collaboration with physicians. One study evaluated the effect of a pharmacist working closely with physicians in a medical resident teaching clinic to improve BP control. Patients with uncontrolled hypertension were randomized to either a control (n = 46) or intervention (n = 49) group. SBP decreased 23 mm Hg in the intervention group versus 11 mm Hg in the control group ( p < 0.001). At the end of the study, 55% in the intervention versus 20% in the control group ( p < 0.001) were at BP goal.
Borenstein reported on the effect of physician-pharmacist comanagement of hypertension in an integrated health system. Patients were randomized to either usual care (n = 99) or a comanaged group (n = 98), who attended a hypertension clinic run by pharmacists. The pharmacist contacted the patient’s physician with an assessment and recommendations based on a previously designed evidence-based algorithm. BP was reduced significantly more in the comanaged group than in the usual care group ( p < 0.01) at 6, 9 and 12 months (22 versus 9, 25 versus 10 and 22 versus 11 mm Hg, respectively). Significantly more patients in the comanaged group (60%) achieved BP goal than in the usual care group (43%, p = 0.02).
We conducted two studies within primary care clinics, most of which included family medicine offices that were randomized to either a control or intervention group in cluster-randomized designs. The first study enrolled 179 patients with uncontrolled BP into a 9-month study with BP measurements by a research nurse. The mean adjusted difference in SBP was 8.7 (95% CI: 4.4, 12.9) mm Hg in favor of the intervention group, whereas the difference in DBP was 5.4 (CI: 2.8, 8.0) mm Hg. The 24-hour BP levels showed similar effects, with mean SBP 8.8 (CI: 5.0, 12.6) mm Hg and DBP 4.6 (CI: 2.4, 6.8) mm Hg lower in the intervention group. BP was at goal in 89.1% of patients in the intervention group and 52.9% in the control group (adjusted odds ratio [OR] 8.9; CI: 3.8, 20.7; p < 0.001).
The second study involved six family medicine medical offices randomized to either the control or intervention group. The study enrolled 402 patients (mean age 58.3 years) with hypertension not at goal into a 6-month intervention or control group. Clinical pharmacists made drug-therapy recommendations to physicians based on national guidelines. Research nurses performed BP measurements and 24-hour BP monitoring. Mean BP decreased 6.8/4.5 and 20.7/9.7 mm Hg in the control and intervention groups, respectively, ( p < 0.05 for between-group SBP comparison). The adjusted difference in SBP was −12.0 (95% CI: −24.0, 0.0) mm Hg. The 24-hour BP levels showed similar differences between groups. BP was at goal in 29.9% of patients in the control group and 63.9% in the intervention group (adjusted OR 3.2; CI: 2.0, 5.1; p < 0.001).
Most of the studies evaluating team-based care, whether with nurses or pharmacists, were conducted in a small number of medical offices. In contrast, the Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION) study was a prospective, cluster-randomized trial of 32 primary care offices in 15 U.S. states stratified and randomized to: control, 9-month intervention (brief intervention [BI]), 24-month intervention (sustained intervention [SI]). One goal was to determine the effect of the intervention after it was discontinued (BI) and another was to determine if the intervention was effective in minority populations. We enrolled 625 subjects with uncontrolled hypertension. There were 239 African-American (38%), 89 Hispanic (14%) subjects, and 50% of the total population had diabetes or chronic kidney disease (CKD). BP control (using the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC 7]) at 9 months was 43% in intervention offices (n = 401) compared with 34% in the control group (n = 224) (adjusted OR 1.57 [95% CI 0.99 to 2.50], p = 0.059). Based on JNC 8, BP control was achieved in 61% of intervention subjects and 45% of control subjects at 9 months (adjusted OR, 2.03 [95% CI 1.29 to 3.22], p = 0.003). The adjusted difference in mean SBP/DBP between the intervention and control groups for all subjects at 9 months was −6.1/−2.9 mm Hg ( p = 0.002 and p = 0.005, respectively), and it was −6.4/−2.9 mm Hg ( p = 0.009 and p = 0.044, respectively) in subjects from racial or ethnic minorities. At the 24-month visit, BP control was 63%, 57%, and 46% in the BI, SI, and control groups, respectively. The adjusted OR for the BI compared with the control group was 1.84 [95% CI 0.89 to 3.78], p = 0.098) and for the SI with the control group was 1.67 [95% CI 0.86 to 3.26], p = 0.13). This is one of the few trials that evaluated what happens when an intervention is stopped. This and other studies suggest that a pharmacy-based intervention has a sustained effect for at least 18 months after discontinued in most patients. This is also one of the few studies designed to demonstrate that the pharmacy intervention was as effective in underrepresented minority populations as in nonminority subjects.
Svarstad and colleagues enrolled 576 African-American patients for an intervention in community pharmacies. Intervention subjects achieved greater improvements in refill adherence (60% versus 34%, p < 0.001), SBP (−12.62 versus −5.31 mm Hg, p < 0.001), and BP control (50% versus 36%, p = 0.01) compared with controls. Six months after intervention discontinuation, intervention participants showed sustained improvements in refill adherence ( p < 0.001) and SBP ( p = 0.004), although the difference in BP control was not significant ( p < 0.05) compared with control participants. This study demonstrated that the pharmacy-based intervention was very effective in African-American patients.
Telephone Interventions
Bosworth compared two self-management interventions for improving BP control among hypertensive patients (n = 636, 49% African American). Randomized to receive usual care, a behavioral intervention (bimonthly tailored, nurse-administered telephone intervention targeting hypertension-related behaviors), home BP monitoring three times weekly, or the behavioral intervention plus home BP monitoring. At 24 months, improvements in the proportion of patients with BP control relative to the usual care group were 4.3% (95% CI, −4.5% to 12.9%) in the behavioral intervention group, 7.6% (CI, −1.9% to 17.0%) in the home BP monitoring group, and 11.0% (CI, 1.9%, 19.8%) in the combined intervention group. Relative to usual care, the 24-month difference in SBP was 0.6 mm Hg (CI, −2.2 to 3.4 mm Hg) for the behavioral intervention group, −0.6 mm Hg (CI, −3.6 to 2.3 mm Hg) for the BP monitoring group, and −3.9 mm Hg (CI, −6.9 to −0.9 mm Hg) for the combined intervention group; patterns were similar for DBP.
Margolis conducted a cluster, randomized trial in 450 subjects. Compared with the usual care group, SBP 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 < 0.001), at 12 months (−9.7 mm Hg [95% CI, −13.4 to −6.0 mm Hg]; p < 0.001), and at 18 months (6 months after discontinuation of the intervention) (−6.6 mm Hg [95% CI, −10.7 to −2.5 mm Hg]; p = 0.004). Nearly all of the effect was mediated by two factors: an increase in medication treatment intensity (24%) and increased home BP monitor use (19%).
Artinian offered free BP screenings to African Americans at various community sites and those with uncontrolled BP and a land-line telephone were randomized to enhanced usual care (UC), including education and identifying resources for receiving medications and clinical care, or UC plus home BP monitoring (HBPM), and nurse managed telemetry. At 12 months the telemetry nurse group had significantly decreased SBP compared with enhanced usual care (net difference −5.5 mm Hg ( p = 0.04). Change in BP control was not reported.
Bosworth randomized patients to either usual care or one of three telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse-administered and physician-administered medication management, or (3) a combination of both. Both the behavioral management and medication management alone showed significant improvements in BP control, 12.8% (95% CI: 1.6%, 24.1%) and 12.5% (95% CI: 1.3%, 23.6%), respectively, at 12 months, but there was no difference at 18 months. In a subgroup analyses, among those with poor baseline BP control, SBP decreased in the combined group by 14.8 mm Hg (95% CI: −21.8, −7.8) at 12 months and 8.0 mm Hg (95% CI: −15.5, −0.5) at 18 months, relative to usual care.
Private physician offices often do not have the resources to hire clinical pharmacists to do the interventions described here. We are conducting two trials to address this problem by using a centralized cardiovascular risk service staffed by clinical pharmacists to assist primary care physicians with improving care management. The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care: (ICARE) trial is being conducted in 12 offices in Iowa and the research pharmacists have obtained EMR access at all intervention offices. Recommendations to physicians are provided directly into the EMR whereas frequent patient contact is done by telephone. We are also conducting another study in 20 medical offices throughout the U.S. that uses a similar intervention. The MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS) trial will evaluate a centralized, web-based cardiovascular risk service (CVRS). These studies should help to determine if clinical pharmacists located at a distant site can help improve the management of chronic conditions.
Medicaid and Underserved Populations
Many states have expanded Medicaid following the Affordable Care Act. These patients can have significant socioeconomic issues that make adherence to BP medications a challenge. Most studies do not specifically focus on patients receiving Medicaid so it is difficult to evaluate specific team-based care strategies. However, several studies did examine interventions in low-income, underserved populations.
Hill studied a more intensive nurse intervention with a less intensive educational intervention in 309 urban African-American men. Mean SBP was 7.5 mm Hg lower in the intensive group compared with 3.4 mm Hg higher for the less intensive intervention at 36 months ( p = 0.001). DBP change from baseline was −10.1 mm Hg for the more intensive group and −3.7 mm Hg for the less intensive group ( p = 0.005 for between-group differences). The proportion of subjects with controlled BP (<140/90 mm Hg) was 44% in the more intensive group and 31% in the less intensive group ( p = 0.045).
Ma and colleagues conducted a randomized trial of nurse- and dietitian-led case management for 419 low-income, ethnic minority patients. The study involved managing multiple risk factors but the main effect was improved BP where SBP was lower in the intervention group (−4.2 mm Hg) compared with usual care (+2.6 mm Hg, p = 0.003). DBP was also significantly lower in the intervention group compared with usual care (−6.0 versus −3.0 mm Hg, p = 0.02).
One study in a Medicaid population found that patients with hypertension commonly receive a large number of other medications with a high probability for potential drug interactions with antihypertensive medications. Two studies of comprehensive pharmacist interventions for multiple problems for patients receiving Medicaid demonstrated improved therapy and reduced costs. In our analysis of the CAPTION trial above, we evaluated whether the pharmacist intervention was as effective in subjects receiving different types of insurance. All subjects had uncontrolled BP at baseline. Although these data are as yet unpublished, we found BP control after a 9-month intervention was achieved in 48% of subjects receiving private insurance, 43% receiving Medicare, 38% with no insurance or self-pay, and 36% receiving Medicaid ( p = 0.102). All of the above studies suggest that more comprehensive strategies will need to be considered to achieve good BP control in patients receiving Medicaid.
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