SummaryHypertensive patients monitor and report multiple blood pressure readings each week through an interactive voice response or secure online system. Pharmacists review the results, calling or e-mailing those with elevated readings to review medication adherence, adjust the medication regimen if necessary, and provide lifestyle counseling as appropriate. The program has reduced systolic and diastolic blood pressure, particularly for those with the highest readings entering the program, and generated high levels of patient satisfaction.Strong: The evidence consists primarily of a randomized controlled trial (RCT) that compared changes in systolic and diastolic blood pressure and other metrics over a 6-month period in 138 participants using an IVR-based version of the program to 145 largely similar patients who did not participate. Some general conclusions from a second, not-yet-published RCT evaluating an online-based version are also presented.
Developing OrganizationsDenver Health and Hospitals; Kaiser Permanente Colorado; Veterans Affairs Eastern Colorado Healthcare System
Date First Implemented2006
Planning for the initial 6-month trial began in February, with patient recruitment commencing in November.
Patient PopulationThe program serves individuals with uncontrolled hypertension who take four or fewer antihypertensive medications. Elevated blood pressure is defined as above 140 millimeters of mercury (mm Hg) for systolic pressure or above 90 mm Hg for diastolic pressure. The cutoff for those with diabetes or chronic kidney disease is 130 mm Hg (systolic) and 80 mm Hg (diastolic).
Problem AddressedMany Americans have uncontrolled hypertension, which can lead to serious health consequences and premature death. Inadequate control stems in large part from poor management of the condition by patients and providers. Patients often lack the time and motivation to come to the doctor’s office to have their blood pressure monitored regularly, while physicians often find it difficult to focus on blood pressure control during time-pressed office visits. Pharmacists can be effective in monitoring and providing feedback and support to patients, but relatively few organizations use them in this role.
- A common, largely uncontrolled condition: Just under a third (32 percent) of Americans have hypertension, up from 24 percent roughly two decades ago.1 Prevalence increases with age and is higher among men through middle age and among women after menopause.2 Hypertension in most individuals remains uncontrolled. Only 38 percent of male and female hypertensive patients age 60 or younger have the condition under control; control levels are similarly poor among hypertensive individuals in other age groups, particularly in women.3
- Leading to negative health outcomes, premature death: Uncontrolled hypertension increases the risk of heart attack, stroke, kidney failure, and heart failure.4 It represents one of the leading causes of premature disability and death.5,6
- Suboptimal management by patients and physicians: Because high blood pressure is a silent disease with little noticeable effect on daily life, busy patients often lack the motivation to have their condition checked by a doctor on a regular basis. For their part, physicians often focus on higher priority acute and chronic conditions during time-pressed office visits.
- Unrealized potential of pharmacist review: Ongoing monitoring, feedback, and support from another qualified health team member, such as a pharmacist, can help patients control their hypertension,7 which significantly reduces the risk of heart attack, stroke, and heart failure. Yet relatively few organizations engage other team members in such roles.
Description of the Innovative ActivityHypertensive patients monitor and report multiple blood pressure readings each week through an interactive voice response (IVR) or online system. Pharmacists review the results, calling or emailing those with elevated readings to review medication adherence, adjust the medication regimen if necessary, and provide lifestyle counseling as appropriate. Key program elements are described below:
- Identifying and approaching eligible patients: Implementing organizations use standard guidelines from the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure to identify those with uncontrolled hypertension. This process typically involves multiple measurements. During the initial trial of the IVR-based system in three Colorado health systems (see Context of the Innovation for more information), system staff reviewed blood pressure data in the electronic medical record (EMR) to identify those with uncontrolled hypertension, and then called eligible individuals to invite them to participate.
- Inperson education: Interested patients come in for a one-time education session that lasts roughly 30 minutes. (During the initial trial, health system staff confirmed eligibility at this visit through electronic blood pressure measurements, with three readings being taken a minute apart.) A medical assistant or nurse confirms that the home blood pressure monitor fits properly and takes accurate readings, and then teaches the patient how to use the monitor and the IVR or online system to report readings from it. For sites using the online reporting system, the nurse or assistant also helps the patient set up an account through the American Heart Association Heart 360® program. At the end of the session, a pharmacist briefly reviews the blood pressure readings from the session with the patient and provides education and support, including distributing take-home pamphlets.
- Regular measurements and weekly reporting: Patients are encouraged to measure their blood pressure periodically throughout the week, ideally on 3 to 4 different days and at different times. Each week, patients report measurements to the sponsoring health system, either through the IVR system by responding to prompts using the touch-tone keypad on the phone, or through the secure, online account, which allows for automatic uploading of results through a thumb drive that attaches to the home monitor. (During the trial of the IVR-based system, 94 percent of participants entered measurements into the system at least once.) The system automatically calculates the average for inputted readings; alerts patients as to whether their readings are at or above goal; and reminds those with elevated readings to expect contact from a clinical pharmacist who will provide additional support. At the end of the call or online session, patients can listen to educational messages or request that the clinical pharmacist call them to answer any questions they may have.
- Reminders for those who fail to report: Those who have not submitted readings during the previous 10 days receive an automated reminder via phone or e-mail. Pharmacists call those who still have not reported data 4 days after this initial reminder.
- Clinical pharmacist review and feedback: The clinical pharmacist reviews each patient’s weekly readings, and conducts an electronic or telephonic visit with those who have elevated blood pressure (patients indicate their preferred method of communication). The pharmacist discusses medication adherence with the patient, adjusts the antihypertensive medication regimen as appropriate, and provides counseling on lifestyle changes. All interventions are within Colorado’s scope of practice for a pharmacist and guided by widely accepted drug therapy management protocols developed the Joint National Committee. If necessary, the patient can receive new medications via mail or at a local pharmacy.
- Primary care physician notification: The patient’s primary care physician (PCP) generally receives notice of any medication changes through progress notes entered into the EMR, with phone calls used on occasion when needed.
Context of the InnovationThree Denver-area systems originally implemented the IVR-based version of this program—Denver Health and Hospitals, Veterans Affairs (VA) Eastern Colorado Healthcare System, and Kaiser Permanente Colorado. Denver Health and Hospitals is a safety-net health system that provides services to a large proportion of indigent, vulnerable, and minority populations in the city and county of Denver. VA Eastern Colorado Healthcare System serves more than 60,000 Colorado veterans through its medical center in Denver and eight outpatient clinics located throughout eastern Colorado. A nonprofit managed care organization, Kaiser Permanente Colorado cares for more than 500,000 patients in the Denver-Boulder-Colorado Springs metropolitan areas. The impetus for this program came from researchers at the three health systems, who recognized the need for more intensive, ongoing management of hypertension so as to increase the percentage of patients with the condition under control. Focus groups with hypertensive patients across the three systems identified coming to the physician as a significant barrier to ongoing self-management (see Planning and Development section for more details). Based on this feedback, researchers began looking for ways to leverage technology so as to allow patients to have their blood pressure monitored and medications adjusted without the need for regular office visits.
ResultsThe program reduced systolic and diastolic blood pressure, particularly for those with the highest readings entering the program, and generated high levels of patient satisfaction.
Strong: The evidence consists primarily of a randomized controlled trial (RCT) that compared changes in systolic and diastolic blood pressure and other metrics over a 6-month period in 138 participants using an IVR-based version of the program to 145 largely similar patients who did not participate. Some general conclusions from a second, not-yet-published RCT evaluating an online-based version are also presented.
- Lower blood pressure: During the initial trial using the IVR system, systolic blood pressure fell by an average of 13.1 mm Hg among program participants, well above the average 7.1 mm Hg decline in a control group receiving basic education about hypertension and instructions to followup with their PCP. Similarly, diastolic pressure fell by an average of 6.5 mm Hg among participants, compared to 4.2 mm Hg in the control group.8 A second, not-yet-published trial found that a version of the program using online reporting had an even larger impact on systolic and diastolic pressure, which led to significantly more patients having their hypertension under control.
- Especially for those with highest initial readings: The IVR-based program worked best for those with higher baseline systolic blood pressure (150 mm Hg or above), while the differences for those with lower readings did not reach the level of statistical significance.8
- Driven in large part by medication intensity: The improvements in blood pressure versus usual care appear to be driven by more frequent clinician review of the patient’s situation and more adjustments to the medication regimen. For example, in the initial trial, program participants had more antihypertensive medications added to their regimen (an average of 0.3, compared to 0.1 for those in the control group) and had a higher intensity of regimen.8
- Higher patient satisfaction: The second trial testing the online-based system found that program participants expressed higher levels of satisfaction with their hypertension care than did those in the control group.
- Cost-effectiveness under evaluation: The second study will examine the cost-effectiveness of this approach by evaluating program costs per major cardiovascular event avoided. Data are not yet available.
Planning and Development ProcessKey steps included the following:
- Conducting initial focus groups: As noted, program developers held a series of focus groups with hypertensive patients in each of the three health systems. These focus groups revealed a lack of motivation among hypertensive patients to regularly visit their physicians. As a silent condition with little impact on their daily lives, hypertension did not seem to justify the significant time commitment necessary to travel to the physician for regular blood pressure monitoring.
- Acquiring and customizing IVR system: Program developers purchased the equipment necessary for the IVR system and developed scripts for automated interactions with patients, such as outbound reminder calls to those who fail to report their blood pressure readings on a regular basis.
- Training pharmacists and medical assistants: Medical assistants attended a 1- to 2-hour orientation session where they learned about the IVR system and how to teach patients to use it. Pharmacists attended a similar session where they learned about the system and their role in the program.
- Introducing program to PCPs: Before the launch, program developers briefly introduced the initiative to PCPs during department meetings. These physicians overwhelmingly supported the concept.
- Conducting initial RCT with IVR technology: As noted, the first study involved testing of an IVR-based system at the three health systems. During the study, program developers realized that some patients did not regularly report all of their readings through the IVR system, including some who only reported their lowest readings, thus giving the false impression to the pharmacist that their hypertension was under control.
- Conducting second RCT with software-based system: To address the reporting problem noted above, program developers launched a second version based on the Heart360 program®, supported by Microsoft’s HealthVault™ platform. Under this system, the blood pressure monitor attaches to a thumb drive that records the readings; the patient then inserts the thumb drive into the computer and uploads all readings through the secure, online account. Several Kaiser Colorado clinics tested this version of the program in a second RCT.
- Continuing and expanding program: Kaiser Colorado and the VA Eastern Colorado Healthcare System continue to use versions the program, with Kaiser working to make the online version a regular part of practice across the entire region.
Resources Used and Skills Needed
- Staffing: The program requires no new staff, as medical assistants, nurses, and pharmacists participate as part of their regular responsibilities.
- Costs: Upfront costs for the IVR-based version include the purchase of software and equipment to operate the interactive voice system (which cost roughly $25,000) and blood pressure monitors. (During the initial RCT, participants received monitors free of charge; now patients pay roughly $30 for a monitor.) Since the software is available free of charge through the Heart360 program®, upfront costs for the online-based version include only the blood pressure monitors. Ongoing program-related expenses are minimal.
Funding SourcesAmerican Heart Association; Colorado Department of Public Health and Environment; Veterans Affairs Research and Development Career Development Award
The Colorado Department of Public Health and Environment provided funding for the initial RCT, with the Veterans Affairs Research and Development Career Development Award program funding the involvement of one of the researchers. The American Heart Association provided funding for the second trial.
Tools and Other ResourcesMore information on the Heart360 program® is available at: https://www.heart360.org/.
More information on the guidelines used by this program can be found at: http://www.nhlbi.nih.gov/files/docs/guidelines/express.pdf (If you don't have the software to open this PDF, download free Adobe Acrobat Reader® software .). These 2003 guidelines were reaffirmed by the U.S. Preventive Services Task Force in 2007.
Getting Started with This Innovation
- Review pharmacist scope of practice: Pharmacists’ ability to adjust medication regimens and provide other treatment advice will vary according to scope-of-practice regulations in each state. Would-be adopters need to review these regulations and structure the program accordingly.
- Maximize ease-of-use for patients: Choose blood pressure monitors and design the reporting system to maximize patient ease of use.
- Offer automatic tracking and entry of readings if possible: As noted, the IVR-based system requires patients to enter readings using the touch-tone keypad on a phone, which creates the potential for errors and/or intentional misrepresentation (such as not entering above-average readings). The online system avoids this problem by using monitors that automatically record all readings on a thumb drive, which can then be used to report readings through a secure online account.
Sustaining This Innovation
- Sell payers on merits of covering pharmacist services: The Colorado systems implementing this program rely primarily on capitated payments, meaning that any program-related reductions in office visits or cardiovascular events benefited them financially. However, provider organizations paid on a fee-for-service basis may not benefit financially, as such reductions will negatively affect revenues and most payers will not reimburse for electronic visits or telephone consultations with pharmacists. To address this issue, sell payers on the program’s ability to save them money by reducing office visits and costly cardiovascular events, such as heart attack and stroke. The goal should be to secure reimbursement for the pharmacist's services and/or negotiate some sort of shared-savings arrangement based on reductions in utilization of expensive inpatient and emergency department care.
- Adjust frequency of self-measurement over time: Frequent at-home blood pressure measurements are critical during the initial part of the program, when a patient’s hypertension often remains uncontrolled. However, once medication and/or other adjustments bring the condition under control, the frequency of measurement can decline over time. Ongoing maintenance of in-control blood pressure likely requires only one or two readings a week.
- Keep PCPs in loop: Educate PCPs about the initiative prior to launch and keep them informed of pharmacist-patient interactions on an ongoing basis. These steps help to ensure that they remain supportive of and enthusiastic about the program.
Contact the InnovatorDavid J. Magid, MD, MPH
Institute for Health Research
Kaiser Permanente Colorado
10065 E. Harvard Ave., Suite 300
Denver, CO 80231
Phone: (303) 614-1212
Innovator DisclosuresDr. Magid has not indicated whether he has financial interests or business/professional affiliations relevant to the work described in this profile; however, information on funders is available in the Funding Sources section.
References/Related ArticlesMagid DJ, Ho PM, Olson KL, et al. A multimodal blood pressure control intervention in 3 healthcare systems. Am J Manage Care. 2011 Apr;17(4):e96-103. [PubMed]
Centers for Disease Control and Prevention. Health, United States, 2010, with Special Feature on Death and Dying. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Available at: http://www.cdc.gov/nchs/data/hus/hus10.pdf
Centers for Disease Control and Prevention. Racial/ethnic disparities in prevalence, treatment, and control of hypertension--United States, 1999-2002. MMWR Morb Mortal Wkly Rep. 2005 Jan 14;54(1):7-9. [PubMed]
Lloyd-Jones DM, Evans JC, Levy D. Hypertension in adults across the age spectrum: current outcomes and control in the community. JAMA. 2005;294(4):466-72. [PubMed]
Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics: 2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-215. [PubMed]
5 Centers for Disease Control and Prevention. A closer look at African American men and high blood pressure control: a review of psychosocial factors and systems-level interventions. Atlanta, GA: US Dept. of Health and Human Services; 2010.
Lloyd-Jones D, Adams R, Carnethon M, et al, American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009;119(3):480-6. [PubMed]
Green BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. [PubMed]
Magid DJ, Ho PM, Olson KL, et al. A multimodal blood pressure control intervention in 3 healthcare systems. Am J Manage Care. 2011 Apr;17(4):e96-103. [PubMed]
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Original publication: March 28, 2012.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: August 27, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: February 19, 2013.
Date verified by innovator indicates the most recent date the innovator provided feedback during the annual review process. The innovator is invited to review, update, and verify the profile annually.