Jan Basile, MD, Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC 29401 E-mail: email@example.com
Optimal blood pressure (BP) control is still not being achieved for the majority of patients with hypertension. Although the topic of patient adherence to health care practitioner recommendations is less than desirable and medication noncompliance adds to the cost of health care, another issue that affects the ability to attain optimal BP control is therapeutic, or clinical, inertia, which is the failure of health care providers to initiate or intensify therapy when indicated. This paper will discuss therapeutic inertia and other issues that prevent BP goal attainment.
The goals for blood pressure (BP) reduction are ingrained in the belief that lower is better. Data from the Blood Pressure Lowering Treatment Trialists’ Collaboration1 provides clear evidence that lowering BP significantly reduces cardiovascular (CV) events. As defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7),2 the challenge to clinicians is to achieve a target BP of <140/90 mm Hg in the general population. According to the American College of Cardiology/American Heart Association (ACC/AHA) recommendations, the goal in high-risk patients is a more aggressive target BP of <130/80 mm Hg. Included in this group are patients with ischemic heart disease, including patients with stable angina, and unstable angina/non–ST-segment myocardial infarction (NSTEMI) and STEMI, as well as those with a Framingham risk score >10%. Patients with left ventricular dysfunction with an ejection fraction <40% have an even lower target BP of 120/80 mm Hg.3
But how well are physicians doing in attaining these goals? The answer is: they are doing better. More patients are aware that they have hypertension (HTN) and more are on therapy than there were 10 years ago. Overall, 57% of patients on treatment are controlled to the minimum goal of <140/90 mm Hg, but, in high-risk patients, the goal of 130/80 mm Hg is achieved only 38% of the time.4
Control Rates: Clinical Trial Experience vs Clinical Practice
Patients in clinical trials often achieve better control rates. Instead of a 57% control rate seen in clinical practice, patients in clinical trials do better, achieving control rates between 65% and 80%. The answers as to why this occurs may help us address some of the barriers to more effective BP control (Table I).
Table I. Barriers to Blood Pressure Control
Lack of understanding of the disease state (checking blood pressure at home)
Barriers in access to care and cost of medications
Fears and concerns about side effects of medications
Payor (health care system)
High cost of medication with tiers of payment
Failure to install computerized medical record and appointment tracking system
Failure to reimburse practitioners for non–face-to-face care
Inappropriate medical regimens
Poor communication with patients
Lack of computerized medical record system
There are reasons why participation in clinical trials provides a more favorable setting for controlling BP than what is observed in a typical clinical practice. In trials, patients are usually randomized to a fixed therapeutic antihypertensive algorithm whereas in a practice setting, based on their age, ethnicity, comorbid conditions, and associated risk factors, physicians will often individualize therapy. In essence, an algorithm eliminates some of the decision-making and variability. A second reason is the use of combination therapy, either starting with a fixed-dose combination agent or using 2 individual drugs. In almost all HTN clinical trials, participants end up on more than 1 drug, which certainly improves BP control. Formulary availability and cost-free medications are also important. And, a fixed appointment schedule is paramount. According to clinical trial protocols, patients have a set number of visits each year, which are usually more than the number of visits that occur in clinical practice, and it is the responsibility of study nurses to make sure that patients fulfill that obligation. Missed appointments are not allowed.
Contrast this with a clinic setting where medical residents, who are so busy with other responsibilities, may actually be happy when a patient with HTN does not show up (they can get back to the ward that much sooner to work up their admissions from that day). Unfortunately, the patient may not be seen for an additional 6 months or longer. If the patient did not have their BP controlled at their previous visit and now does not show up for their current appointment, they may go a year with uncontrolled BP. Missed appointments are a missed opportunity for BP control and should not be dismissed. When hypertensive patients do not show up for their clinic visit, they need to be contacted. It needs to be stressed to them that it is important they be seen to control their disease process.
Another difference between clinical trials and clinical practice relates to the computer-based results that are provided in clinical trials for record keeping. This process allows for an easy reference to check on laboratory values (eg, serum potassium, glucose, and lipid levels) as well as long-term BP control. And, finally, there is the volunteer effect. Patients sign up for clinical trials. They are vested in helping us help them and they know that what happens to them will affect other people with HTN in the future. If this philosophy could be carried over to general practice it would greatly improve compliance and control.
Clinicians need to understand what motivates patients to become involved and take ownership for treating their own disease, especially with a chronic condition like HTN. In doing so, medication adherence will likely increase and outcomes are more likely to improve. Motivating factors include appropriate health beliefs (such as the perceived seriousness of HTN), vulnerability to complications, and efficacy of the chosen treatment. If a treatment regimen makes sense to the patient, seems effective, and the patient believes benefits exceed the cost, they feel they have the ability to succeed. This should translate into an improvement in overall adherence to therapy and BP control.
The volunteer effect, on the other hand, can impact the overall results of a clinical trial. Because these patients are more likely to be interested, engaged, and follow directions, a selection bias may exist that could increase the chance that BP control rates will be higher in clinical trials than in real-life practice. In addition, patients in clinical trials often receive increased attention and surveillance. Subsequent results could lead practitioners to draw the wrong conclusions of the overall efficacy of the drug(s) being studied. These points suggest that there need to be more effectiveness trials (studied under conditions similar to general practice) than efficacy studies (conducted under ideal conditions) if comparison on BP control percentages between clinical trials and routine practice are to be made.
Clinical trials often incorporate home BP measurement as a means of assessing response to therapy. When patients have a device at home to perform self-measurement, adherence to therapy and BP control both improve. Home monitoring of BP eliminates white coat HTN and may help evaluate patients for masked HTN, identifying the patient that often has pre-HTN in the clinic but who actually has HTN out of the office. Home BP more strongly relates to target organ damage and has better prognostic accuracy than office BP. Of course, in clinical practice, there is the problem of reimbursement. Physicians get paid for office measurement of BP, and convincing insurance companies to reward physicians for the work they do in monitoring out-of-office BP is a hard sell; however, this reimbursement is one that must eventually occur. Controlling BP requires a lot of energy and takes a lot of effort from the clinician, and all of the work that is required to control BP should be rewarded!
Other barriers to controlling BP include the high cost of medication and issues involving health care office systems that must be improved. Most offices do not currently have a computerized medical record system or an appointment tracking system, which can have a favorable effect on BP control.
Clinicians often think they provide better care to their patients than is actually provided. In a study from Veteran Administration (VA) hospitals, resident physicians were asked whether their patients’ BP was controlled to levels <140/90 mm Hg. Sixty-seven percent of the residents felt that they met the goal. However, an electronic chart audit revealed that only 42% actually met the criteria.5 So exactly what is therapeutic inertia (TI) or clinical inertia? It is the failure of health care providers to initiate or intensify therapy when indicated.6 Soft reasoning often leads to avoidance of therapy intensification. If a patients’ BP is 142/92 mm Hg, often no change is made in therapy since the clinician reasons that there is no need to either up-titrate or add another medication to further improve BP control as the patient is almost at goal BP. After all, the patient will be seen again in 6 months. This indicates a lack of understanding of the benefits of treating to therapeutic targets.
Burlowitz evaluated five VA medical centers in the New England area and despite an average of ≥6 HTN-related visits per year among patients with uncontrolled HTN (39% had BP >160/90 mm Hg), only 25% achieved BP <140/90 mm Hg. Systolic BP fell 6.3 mm Hg in patients receiving the most intensive treatment, while BP increased over time among those receiving the least intensive regimen. The authors concluded that most clinicians generally do not take an aggressive enough approach in their treatment of HTN.7 In essence, they are guilty of TI.
In a questionnaire study by Oliveria, physicians were asked, “Was the prescribed medication for HTN initiated or changed at the patient visit when the systolic BP was greater than 140 mm Hg?” The results showed that 93% of patients had systolic BP at 140 mm Hg or higher, but only 38% of the 300 respondents had either started or changed the antihypertensive medication at the visit.8
A study from our own group surveyed 62 practices in the Carolinas-Georgia American Society of Hypertension chapter that included South Carolina, North Carolina, and Georgia. TI was defined as systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, with no change in antihypertensive therapy. This occurred in almost 87% of visits and usually occurred when the BP was very close to goal. When practitioners did not suffer from TI, the systolic BP was reduced an additional 13 mm Hg and the diastolic BP another 6 mm Hg, resulting in a far better BP control rate.9 So, clearly, clinicians that are more likely to either increase the dose of a medicine or add a medicine are more likely to get their patients to goal.
Guideline adherence may also be a factor in BP control. Mosca reported on a questionnaire study of 300 primary care physicians and 100 cardiologists, simply asking whether they were aware of the JNC guidelines and whether they incorporated the JNC guidelines into their practice. Only 42% actually used the guidelines, even though they were aware of the guidelines.10
In a managed care setting, a large dataset analysis showed that when patients were close to goal, practitioners were much less likely to either increase the dose of medication or add a medication; however, when the goal was farther away, they were less likely to suffer from TI.11 And that makes sense. However, if the object is to get BP more effectively controlled, and that every millimeter does count, patients that are close to goal but not at goal still need additional therapy.
Causes of TI
What are the causes for TI? One is clinician acceptance of elevated BP, especially if they are satisfied with the current BP level. Many clinicians assume that if BP readings have been on a downward trend, a borderline BP will likely be better the next time. In fact, the probability is just as high that the BP could be elevated or stay the same and remain uncontrolled. Another problem is that many providers seem to assume that they have “hit the finish line” once BP is <140/90 mm Hg. On any given day, or even during the course of the same day, BP could be higher or lower than the value taken in the office, so “just barely achieving” a target BP goal one time may not be good enough. Continued vigilance of the patients’ BP is of utmost importance!
In addition, clinicians may focus on targeting only one aspect of BP, usually the diastolic reading. So, achieving a diastolic BP of <90 mm Hg is not the problem: 73% reach that goal. However, only about one third of patients achieve systolic BP <140 mm Hg. Thus, an elevated systolic BP is a metric that is more difficult to control and the most important to address. If clinicians focus just on this top number, at least in the adult population, BP would be controlled in the vast majority of patients.12
Another reason for TI is time constraints. Primary care clinicians following hypertensive patients have only about 15 minutes to see a patient. During this time frame they have to listen to the patient’s chief complaint and take care of all of the patient’s health care screening. So it is easy to see why a marginally high BP is often not addressed. It is a problem of competing interests: patients have a chief complaint, chronic comorbidities, and preventive care concerns, so little time is devoted to BP control.
Then there is a lack of clinician incentive. Adhering to guidelines and achieving treatment goals are not adequately rewarded in the US health care system. Should pay-for-performance be adopted? Should clinicians be monetarily rewarded if they are able to more effectively control BP? An ongoing multicenter study in the VA is currently looking at this issue. In the study, one group of practitioners is monetarily rewarded if they are able to get BP controlled while a second group of practitioners are aware that they will not be rewarded. Does this incentive contribute to one’s ability to get BP better controlled? One concern has been that pay-for-performance programs may penalize health care providers treating patients with multiple chronic coexisting conditions. A recent study examined 141,609 veterans with HTN and divided them into 4 condition groups: those with HTN and concordant conditions (diabetes mellitus, ischemic heart disease, dyslipidemia); those with HTN and discordant conditions (arthritis, depression, chronic obstructive pulmonary disease); those with both; and those with neither. Contrary to expectations, patients with greater complexity had a higher likelihood of receiving high-quality care for HTN. Subjective ratings of care did not vary with the presence or absence of comorbid conditions. These findings should reassure those who care for the most medically complex patients with HTN.13
Finally, we must examine the role of the patient while understanding their beliefs toward the complexity and seriousness of their disease. In a study by Ross and colleagues, 14 patients were asked to complete a questionnaire that included the beliefs about medicines and illness perception questionnaires. Analysis revealed that patients who believe in the necessity of medication are more likely to be compliant (P<.001). In addition, Kressin and colleagues15 found that patient confidence in their ability to take BP medications as prescribed was associated with better adherence (P≤.02). Therefore, patients with more chronic conditions, especially serious CV disease, may be more likely to take their medication and achieve control.
Overcoming Clinical Inertia
So what are the solutions? Utilizing a computerized medical record system or a noncomputerized point-of-care decision-making support system is a start. It should include clinical reminders or prompts to the physician when the patients’ BP is above goal. This process should also include preventive measures, checklists, and flow sheets.
If BP is not at goal or if the clinician is not utilizing a drug that the health care system feels the clinician is “compelled” to use as part of that “cocktail,” a prompt should appear on the computer to remind the physician, “Have you thought about this?” Examples of prompts would include a patient with diabetes who is not taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), a patient who is post–myocardial infarction (MI) and is not taking an ACE inhibitor or a β-blocker, or a patient with a recent MI who is not taking a statin. All of these scenarios would elicit a computer prompt calling for a decision and an action. Simplifying treatment through the use of algorithms needs to be adopted, implemented, and followed.
Other solutions include expanding clinician support by utilizing nurse case managers or BP clinics staffed with clinical pharmacists (PharmDs). The VA Cardiovascular Risk Reduction Clinic utilizes PharmDs for patients that have difficult-to-control BP. These members of the health care team see patients intercurrently when the clinician is not able or not scheduled to do so, communicating electronically back to the clinician exactly what has been discussed. PharmDs reinforce the BP control message and the importance of medication adherence with the patient while reviewing the patient’s medication schedule with them. For example, in the Collaborative Management of Hypertension study, a physician/pharmacist team achieved an 89% BP control rate within 9 months using such an approach.16 Although poor medication adherence was a minor problem in this population, overcoming TI was the likely reason for the results, as the pharmacists intensified BP medications when BP goals were not met.
Clinician Performance Feedback
Clinicians do not like to be different than their colleagues. They do not like to see they are failing to control BP as well as their peers or that in their patients with diabetes, fewer are taking an ACE inhibitor, ARB, or statin. In this regard, a computerized audit system can be a motivating incentive.17 When singled out as an outlier, physicians are motivated to question and determine why they are different, oftentimes resulting in corrective measures. Similarly, a systematic self-measurement of performance and timely feedback on performance helps motivate physicians to overcome clinical inertia.
Another way to get around TI is to use more combination therapy. In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 27% of patients were initially controlled to a BP goal <140/90 mm Hg. This improved to 67% over the 5 years of the trial and only 26% remained on just one drug. In fact, many were ultimately taking 3 and some taking 4 antihypertensive drugs. More patients need more drugs to obtain more robust goals.18
The Food and Drug Administration (FDA) has finally accepted and approved many antihypertensive drug classes to be used in fixed-dose combination pills as initial therapy. Originally only indicated for severe HTN, the FDA has recently approved fixed-dose combination therapies as initial therapy in patients likely to need multiple drugs to achieve BP control, which applies to the vast majority of those with HTN.
More evidence in support of fixed-dose combination therapy comes from the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH) trial. Although BP was initially controlled in 37% of those entering the trial, after 6 months of treatment, control rates were up to 74% starting with either an ACE inhibitor/thiazide diuretic or an ACE inhibitor/calcium channel blocker. Data pooled from both fixed-dose combination treatment arms showed an impressive 80% control rate (goal <140/90 mm Hg) after 30 months of treatment.19
And what about the polypill? Although not appropriate for routine care, results from a study of 108 treatment-naive patients with HTN who were administered a low-dose polypill containing 4 different antihypertensive agents found that BP was controlled more effectively using a low-dose of the 4 individual agents than higher-dose treatment with any of the 4 individual components.20 Since complex stepped-care treatment regimens recommended in national guidelines are not being currently adopted in routine clinical practice, a simpler initial fixed-dose combination algorithm (Simplified Treatment Intervention to Control Hypertension [STITCH]) has been evaluated in Canada.21 This treatment algorithm, which utilizes low-dose diuretic/ACE inhibitor or a diuretic/ARB combination as initial therapy, achieved BP control more quickly and more effectively during the 6 months of treatment without any more side effects when compared with the traditional step-cared approach of initial monotherapy currently recommended by the Canadian Hypertension Education Program. (Figure 1 and Figure 2) The results of the study suggest that a simplified algorithm using initial low-dose fixed-dose combination therapy is superior to one using an initial stepped-care single agent approach. This strategy should also help to reduce TI in the future.
What will it take to improve BP control (Table II)?22 First, there must be communication between the physician and the patient. The BP goal should be communicated clearly to the patient, preferably written on the prescription. Physicians should set clear expectations with the patient, explaining that 2 or 3 medications may be needed to control their BP, as well as the many treatment changes that may occur over time to achieve the target BP goal. In addition, many patients believe that it is a “failure” if BP control cannot be achieved with the first medication and they need to understand that this is normal.
Table II. Ways for Clinicians and Providers to Improve Blood Pressure (BP) Control
Communicate BP goal to the patient by writing it on the patient’s prescription bottle.
Monitor adherence, having patients bring in prescription bottles to the office.
As necessary, educate and involve the patient’s spouse, children, and other family members on the BP goals for the patient.
Address side effects. Tell the patient, “If there is any reason you cannot take the medication, please call the office and I will get back to you.”
Emphasize the importance of changes in the patient’s lifestyle.
Simplify regimens using combination tablets.
Enlist patients’ involvement in their own care by having them measure and record their out-of-office BP values and fax them to your office.
Use regular follow-up appointments with telephone reminders 2 days before the appointment.
Reduce cost when it is an issue.
A missed appointment is a missed opportunity.
The clinician should set clear expectations with the patient;
it is likely that 2 or 3 medications will be required to control their BP, as well as many changes in therapy along the way to achieve their targeted BP goal.
Education and involvement of the patient’s family, spouse, and children can help improve the patient-physician relationship. The importance of lifestyle changes should be emphasized not only to the food buyer but also to the food preparer. Enlisting the patient’s involvement in their own care by having them measure and record the out-of-office BP values helps engage the patient. Having patients take their own BP at home increases the likelihood that they will take their medicine and get their BP under control. If the patient does home monitoring and sends the recorded data to the physician, the physician needs to read the report and respond to it by either calling the patient or seeing the patient in the office. Regardless of the practice chosen, consideration should be given to either up-titrating or adding a medication if the BP is not under control. In addition, simplify the treatment regimen whenever possible using fixed-dose combination tablets when this makes financial sense.
Regular follow-up appointments using telephone reminders 2 days before the appointment helps avoid missed opportunities. And, missed appointments are missed opportunities. Physicians need to be more vigilant in communicating with patients who don’t show up for their appointment. We cannot forget about them because it’s less work for us that day. Less work that day will create a backlog of care that will have to be administered in the future. Do today’s work today!
Disclosures: Dr Basile receives grant/research support from the National Heart, Lung and Blood Institute, Boehringer Ingelheim, and Novartis. He has served as a consultant for AstraZeneca, Merck, Novartis, and Daiichi Sankyo and on the speakers’ bureau of Abbott, AstraZeneca, Boehringer Ingelheim, Forest, Merck, Novartis, Pfizer, and Daiichi Sankyo. The author acknowledges the assistance of Practicum Educational Services in preparing this article and styling the paper for journal submission. Editorial support was provided by Ronald K. Miller, PhD, and funded by Daiichi Sankyo, Inc. The author received an honorarium from Daiichi Sankyo, Inc, for time and effort spent preparing this article.