This three-arm randomized controlled trial compares usual care of hypertension to two interventions that use the Chronic Care Model for planning via a secure patient website and the electronic medical record to deliver: (a) a self-management support intervention; and (b) this plus collaborative care management support, to improve hypertension care.
The self-management support intervention includes receipt of a home blood pressure monitor and proficiency training on using it. Self-monitoring of blood sugar has been shown to improve important health outcomes in diabetes and is a standard part of self-care [19
]. However, the role of home blood pressure monitoring has been less certain [71
] despite: the availability of validated, inexpensive, and easy-to-use electronic monitors [33
]; high acceptability of home blood pressure monitoring to patients [74
]; documented problems associated with office blood pressure measurements [75
]; and recent evidence showing good correlation between home blood pressure recordings and clinical endpoints [76
]. The JNC7 [42
] states that “home blood pressure monitoring may be useful for some patients,” but gives no specific guidelines for using it. Fahey [13
], in a meta-analysis for the Cochrane Collaborative, found that self-monitoring resulted in a significant decline in diastolic blood pressure, but a non-significant trend toward improved hypertension control. In a meta-analysis by Cappuccio, self-monitoring patients had significantly lower systolic and diastolic blood pressure and were more likely to achieve predetermined blood pressure targets, particularly if they were actively involved in monitoring their blood pressure [78
The Chronic Care Model provides a map for designing a multifaceted, multi-level integrated intervention, which can be directly replicated in different care settings. Attention to, and integration of, all the six domains () improves patient functional and health outcomes but has yet to be applied to the care of hypertension. We chose to study interventions of increasing intensity, with group 2 (BPM-I) receiving self-management support tools and training, while group 3 (BPM-I + Pharm) receives additional pharmacist care management. In a study testing self-management support plus pharmaceutical care for asthma, self-management support alone was sufficient to improve outcomes [19
]. It might be possible that patients on their own could improve their hypertension care by using home blood pressure monitors and communicating these by e-mail directly to their healthcare team; and as noted above, self-monitoring of blood pressure studies improved blood pressure control [78
]. In a recent meta-analysis, while home blood pressure monitoring and patient education strategies positively influenced blood pressure control, adding a healthcare team member to focus specifically on hypertension resulted in greater changes, particularly if the assigned person managed medication adjustments [28
]. Methods for integration of the team member into routine care and the costs of this care were less certain. We use clinical pharmacists as the agents for changing the design of the care-delivery system, because they perform similar roles at Group Health for other chronic conditions with improved rates of statin and ACE inhibitor use in patients with heart disease and diabetes. Studies show that pharmacy care interventions have positive effects on blood pressure control and medication adherence [79
]. Depending on local resources, however, these functions could be delegated to nurses, who might have more comfort with aspects of care unrelated to medications (e.g., lifestyle issues or clinical concerns).
This study has several limitations. The interventions take place within an integrated healthcare setting. Physicians in private or small group practice may not have access to the same resources, including patient websites and electronic medical records. Substantial capital investments and provider time are required to implement electronic information, communication, and charting systems. Healthcare provided electronically is generally not reimbursed [83
]. Additionally, many patients (particularly those in socioeconomically disadvantaged or older age groups) do not have access to the Internet [84
]. However, access to the Internet is rapidly increasing in all age, socioeconomic, and ethnic groups, with over 70% of the American population connected as of 2006 [85
]. The population in this study also may be unique, in that the Pacific Northwest has a smaller proportion of racial and ethnic minorities, in particular African Americans, than other parts of the country. African Americans have a higher incidence of hypertension and poorer control than other ethnic groups [86
] and may be more likely to refuse to participate in a study [87
]. Another potential limitation is that patients receive their blood pressure monitor and training at their home medical center, but all other interventions occur remotely. If the pharmacists were located in each medical center, they might be able to serve as a local champion for improving hypertension care and potentially diffuse evidence-based hypertension care to other healthcare providers. Closer geographic proximity to the patient and the provider also might add a personal touch (particularly for communications with the physician). Using few pharmacists, however, let the hypertension specialist supervise them closely and let them become experienced with hypertension care. Many healthcare insurance companies and physician practices are already outsourcing care for chronic conditions to care management teams at remote sites [88
]; however, most often this is not directly linked with other aspects of the patients’ healthcare, as was possible for this intervention. With increasing dissemination and availability of information technology services, adding care management processes outside of the physician’s office will become simpler to integrate into routine care. In this study, pharmacists managed only those patients who had benign essential hypertension; those with more complex problems were excluded. Pharmacists could provide most care without directly involving the physician: Communication was routine, and collaboration occurred for any clinical concerns, but the physician did not have to respond or place orders. Based on our review of the literature and later the Walsh meta-analysis [28
], we hypothesized that family physicians often are too busy to do the iterative work required for ongoing management of blood pressure; and pharmacist focus and autonomy (within the guidelines of a protocol) would lead to increased hypertensive medication adjustment and improve blood pressure control. Additionally, as care was delivered over the Internet, we wanted to assure safety before testing more complex scenarios. A patient-centered approach might justifiably focus on the patient and all their conditions and not just hypertension and cardiovascular risk. If this intervention is successful, algorithms could be designed and tested to care for patients with diabetes, heart disease, and other conditions. On the other hand, many patients with hypertension have no other chronic conditions, and most have uncontrolled hypertension.
This study also has several notable strengths. Group Health already employs many of the components of the Chronic Care Model shown to be effective in improving chronic care. Group Health has guidelines, decision support, self-management support tools, and healthcare system and linked community resources to assist patients and providers in the care of hypertension. A particular strength is the organization’s robust clinical information system, which includes a secure patient website and an electronic medical record. In Crossing the Quality Chasm: A New Health System for the 21st Century
, the Institute of Medicine recommends that information technology be used to improve patient-centered care [89
]. A Rand Corporation analysis predicted that wider use of information technology would result in improved healthcare outcomes and efficiency, and lower costs [90
]. Goldberg et al. [91
] demonstrated the feasibility of a Web-based disease management module that lets patients with diabetes upload their blood glucose readings, view portions of their medical record, and e-mail their provider. This study will test the effectiveness of training and encouraging patients to use the secure patient website to improve their hypertension control. The study will also determine whether pharmacist care provided over the Web, linking the patient website and the electronic medical record, improves hypertension control. If successful and cost-effective, home blood pressure monitoring and electronic communication could be used to improve the care for large numbers of patients with hypertension.