Despite accumulating evidence of the benefits of LDL lowering over the past two decades, initiation of treatment and long-term adherence to therapy remain far from optimal. Lack of adherence is causing persons to miss the risk-reducing benefit of treatment, and is creating enormous costs in the health system to treat cardiovascular events that could have been prevented. Clinical trials have demonstrated that LDL-lowering therapy can reduce all major adverse manifestations of CHD. Clinical trials also have shown that the amount of risk reduction achieved13,1065,1066 is related to the level of adherence with treatment. Adherence to lipid management in the United States, as well as cardiovascular preventive therapy in general, is less than desirable, as reflected in the following findings:
Less than half of persons who qualify for any kind of lipid-modifying treatment for CHD risk reduction are receiving it.1067-1071
Less than half of even the highest-risk persons, those who have symptomatic CHD, are receiving lipid-lowering treatment.1067-1071
Only about a third of treated persons are achieving their LDL goal; less than 20 percent of CHD patients are at their LDL goal.1069,1070
Only about half of the persons who are prescribed a lipid-lowering drug are still taking it six months later; after 12 months this falls to 30-40 percent of persons.1072 This is especially disconcerting, since it takes 6 months to 1 year before a benefit from treatment becomes apparent.
Unfortunately, guidance from the available literature as to what should be done about the adherence problem is sparse. A recent, rigorous search of the world's literature to identify interventions proven to help persons follow prescription medications uncovered a total of 4,762 citations.1073 Of these, just 19 met the criteria of an unconfounded randomized clinical trial, a standard to which all of our important decisions in health care are held. The panel of experts that reviewed this data concluded that current methods of improving adherence with chronic health problems are not very effective, and that there is little evidence that medication adherence can be improved consistently.
Poor adherence with lipid-modifying therapy threatens the success of any set of recommendations. The recommendations contained in this document are being made on the premise that a sustained reduction in serum LDL cholesterol levels will be accompanied by a reduction in CHD events. For this benefit to be realized, treatment will have to be continued for years and probably for the duration of the patient's life. Thus, paying attention to ways of improving adherence with treatment is just as important to the ultimate success of these guidelines as are the rudiments of the guidelines themselves. Health professionals are encouraged to review the material that follows for guidance on how they may address adherence issues in their daily practice.
1. Recurrent themes and perspectives
A review of the adherence literature reveals recurrent themes and perspectives that provide insights about the adherence problem and suggest ways of dealing with it effectively. Some of these perspectives are listed below:
Most people do not successfully self-administer medical treatments as prescribed without some intervention designed to enhance adherence.
Adherence is not related to gender, age, ethnic or socioeconomic characteristics of patients. The young are just as likely to be as non-adherent as the elderly; the wealthy just as likely as the poor; males as much as females. There are no differences in adherence rates among African Americans, Hispanic Americans, Asian Americans, and Anglo-Saxon Americans. The causes of non-adherence transcend these differences among people.
There is no one cause of poor adherence. Different causes are invariably operating in any group of persons given the same regimen for the same reason. For example, for some persons the cost of the prescription is critically important in determining adherence, but for the majority it is not. Some people forget to take their doses. Others do not believe that they are sick enough to require drug treatment. Still others fear side effects from their treatment. The list of reasons goes on. Since there is no single cause of poor adherence, there is not likely to be any one intervention that will improve adherence in all persons.
Patient counseling and written instructions appear to have the greatest impact on improving short-term adherence (e.g., with antibiotic drug regimens) but less impact on long-term regimens.
Poor adherence is just as much of a problem in persons with symptomatic illnesses (e.g., epilepsy and diabetes) as it is with asymptomatic disorders (e.g., hypertension and hyperlipidemia).
Initial good adherence with therapy does not mean that the patient will continue to be adherent.
If a patient admits non-adherence with therapy, he/she is usually telling the truth, but if a patient denies non-adherence, he/she is telling the truth about half the time.
A certain consistent proportion of persons (probably about one-third) will be adherent with therapy just by being given a prescription and asked to take it by their physicians. Another proportion of individuals (probably about 15-25 percent) will be non-adherent with therapy, even with the most vigorous interventions. Interventions to improve adherence, then, are optimally aimed at the middle 50 percent of individuals who may adhere if given support and encouragement.
Practically any intervention appears to improve adherence. Rarely are interventions not effective in improving medication adherence, at least for a while. This suggests that the increased attention paid to adherence and/or to the patient by a provider may be as important as the intervention itself.
Medication-taking is a behavior that must be learned. Not all individuals have the skills, support structure, or belief system to adopt this behavior without help.
Physicians and other health providers have little training in behavioral modification techniques, and do not naturally apply behavioral change principles to improving medication-taking behavior. That is, physicians and other professionals need training in adherence-improving strategies.
Many primary care providers and other health professionals spend little time in their practices to provide interventions to encourage adherence with therapy.
There are too few incentives built into the health delivery system (e.g., compensation) to encourage and support health professionals to address poor adherence among patients.
Interventions to improve adherence must be sustained and reinforced. Interventions to improve adherence last only as long as they are provided. If the intervention is discontinued, even if the patient is fully adherent at the time, adherence will deteriorate.
Most successful interventions, especially for long-term drug therapies, use multiple approaches simultaneously.
The more patients are asked to do, the less likely they will be to do it all. Rather, they will choose what they are willing to do. This may not be the optimal choice.
Adherent behavior reduces morbidity and mortality, even among placebo-treated individuals.1074 This suggests that the patient who takes steps to improve his/her health achieves a better outcome than the patient who does not.
2. Interventions to improve adherence
The list of evidence-based approaches for improving adherence has been organized under interventions focused on the patient, health professionals, and the health delivery system. In the final analysis, the most successful plan to improve adherence will likely use approaches from all three categories.
Each health professional should use this list to develop a plan for encouraging adherence by patients in their practice and managing poor adherence by those who fail to achieve treatment goals. An important component of the plan will be to identify what the primary care provider will do to encourage adherence, and how other health professionals, resources and systems can support and augment this initiative. Another important component of the plan will be how to weave adherence-improving approaches into the ongoing daily process of caring for patients.
a. Interventions focused on the patient
Following is a list of practical recommendations for improving adherence that are focused on the patient. (See Table IX.2-1 and the discussion below). A combination of approaches shown in Table IX.2-1 can be used for maximal effectiveness. For maximal efficiency, the health professional should focus the greatest attention on individuals whose lipid control is inadequate due to poor adherence.
1) Simplify medication regimens
Taking medications once daily, rather than three to four times a day, enhances adherence with the regimen.467,1075 As well, keeping the number of drugs in the regimen to a bare minimum is important. This may be particularly important in the patient with multiple risk factors or CHD where 6-12 medications are often prescribed. In these circumstances, the clinician should thoughtfully consider what therapy is a must and then negotiate with the patient about what they are willing to take. Compromise here may not provide optimal therapy, but prescribing too many medications will lead to poor adherence with all medications and not achieve any of the therapy goals.
2) Provide explicit patient instruction and use good counseling techniques to teach the patient how to follow the prescribed treatment
Persons must understand what is expected of them in order to do it. A number of studies affirm this principle and have illustrated that patient instruction is far more than just giving patients some information.1076-1078 If the goal is to change or reinforce adherence behavior, the instruction needs to be constructed with this goal in mind. Following are suggestions to impart behaviorally-based instruction:
Begin with an assessment of the patient's current understanding. Identify the patient's concerns and misunderstandings. Determine what the patient has already tried to do about their cholesterol problem, what problems they encountered, and how they sought to overcome these problems.
Determine what benefit the patient expects to receive from the treatment. Reinforce or amplify these expectations.
Negotiate cholesterol and dietary goals with the patient. Select short- and long-term goals, and set timelines for achieving the short-term goals.
Provide explicit instruction on a low-fat diet, including how to shop for foods, how to select foods when eating out, and how to order foods while traveling. This is often best accomplished by a dietitian or a nurse.
Provide explicit instruction on how to take lipid-modifying medications. Emphasize the need for continued treatment for CHD risk reduction. Reassure the patient about the safety of the regimen (if appropriate). Emphasize the potential benefits of treatment. Attempt to link these benefits to the LDL level, which provides the patient with a measure with which to track progress.
Make adherence with therapy an ongoing topic of discussion. Inform the patient that you will be asking about this at each visit and will want to explore ways to help overcome any problems encountered.
Make instructions concise and reinforce them with written materials or Web-based information.
Take time to answer the patient's questions. Verify that the patient understands the instructions.
3) Encourage the use of prompts to help persons remember treatment regimens
Forgetfulness is one of the most common reasons given by patients for not taking medications. Most persons will have to identify ways to prompt them to take medications.1077-1081 Following are a few approaches that have been tried and proven successful:
Integrate medication doses with other daily activities, such as meals and bedtime.
Use alarms on clocks or watches to signal dosing times.
Use special medication packing (e.g., pill boxes) to organize medications.
Phone persons to remind them of medication refills.
Phone persons or send postcards to remind them of return appointments.
4) Use systems to reinforce adherence and maintain contact with the patient
A variety of systems have been used to enhance adherence with low-fat diets as well as lipid-modifying medications.1082-1087 One simple and inexpensive way is to have the office nurse or dietitian phone the patient between appointments to review information on the treatment regimen, solve problems being experienced by the patient, answer questions, and reinforce adherence behavior. Telemedicine is particularly important to use when the time between appointments is protracted. Another option is a computer link via the patient's phone so that patients can report their home blood pressure recording. Health professionals can also check with patients about their understanding of medication regimens, inquire about adherence, and provide information and instructions. It is quite conceivable that Web-based systems and e-mail can be effectively used to send and receive messages with the patient that reinforce adherence and maintain contact with the patient.
5) Encourage the support of family and friends
The power of the “significant other” in influencing the patient's behavior is substantial and can be used to advantage in encouraging adherence with a treatment regimen. A spouse or special friend who is taught about the patient's therapy, and becomes an advocate to reinforce adherence behavior and help solve problems, has been shown to be effective.1088-1090 Obviously, this must be done with the patient's permission and acceptance. In some circumstances, getting the family or friends involved can have adverse effects.
6) Reinforce and reward adherence
Reinforcing the importance of lipid control and providing rewards for progress are two of the most powerful methods of achieving treatment goals.1077,1079 Most commonly, reinforcement is accomplished by asking about adherence at each visit, reviewing lipid results at followup visits, and charting the patient's progress toward achieving their treatment goals. It is best to avoid giving negative feedback in these settings; rather, recognizing even small positive changes is more likely to encourage larger positive changes. When persons achieve short-term goals, it is important to acknowledge (i.e., reward) it. Most often, reward is simply the praise of the health professional. In some cases, rewards may be tangible, such as points toward a free cholesterol evaluation or home test system. Studies have shown these to be powerful methods for encouraging adherence behavior as well as achieving improved outcomes.1079
7) Increase patient visits for persons unable to achieve treatment goal
See patients more often when they are struggling to get their cholesterol under control, and less often when their control is good. Always call patients who miss appointments.
8) Increase the convenience and access to care
Although it may be impractical to many providers, studies have shown that when care is provided at the worksite or during home visits to improve access and convenience of care, adherence with therapy is improved.1077,1079,1080,1089
9) Involve patients in their care through self-monitoring
Involving the patient in their treatment through self-monitoring is another powerful way to improve adherence.1091-1093 In this manner persons can follow firsthand their response to treatment and their progress toward achieving and maintaining treatment goals. They can also observe the consequences of nonadherence.
b. Interventions focused on the physician and medical office
As indicated above, many persons with a lipid disorder who qualify for treatment are not receiving it from their physicians. Generally this is not due to the physician's lack of familiarity or agreement with the NCEP guidelines, their interest, or their intent to successfully implement them.1094,1095 Instead, barriers exist which impede treatment, including the physician's lack of confidence in treating certain lipid disorders and implementing certain elements of treatment—especially diet and exercise therapy; inertia in making fundamental changes in current practice patterns; contradictory patient preferences; and time constraints.1095
Generally, when given assistance, physicians are receptive to making changes in their practice and improving preventive health services.1094,1096-1099 They are especially motivated to change if their patients request these services, if they perceive a legal liability, if peers or thought-leaders advocate these services, and if they perceive that treatment is cost-effective.1096 Given a readiness to change, the question is what the more effective ways are to encourage physicians to make changes in their daily practices to improve adherence with therapy. Some of the more important interventions are summarized below and listed in Table IX.2-1.
1) Teach physicians to implement lipid treatment guidelines
Although traditional CME programs that use lectures and conferences to teach physicians rarely change professional practice,1100 they can increase awareness and motivate physicians to learn more specific approaches to therapy. Moreover, when physician-training programs supply important background material (i.e., science) and guidance on ways to implement treatment guidelines into everyday practice, they are more likely to influence practice. For example, when training programs provide the physician with enabling strategies (e.g., office reminders), reinforcing strategies (e.g., feedback) and predisposing strategies (e.g., practice guidelines), improvements in the quality of practice are more commonly seen. Some of these strategies are reviewed below.1096
2) Use reminders to prompt physicians to attend to lipid management
Reminders have been used successfully to prompt physicians to attend to lipid issues.1100,1101 This may be as simple as placing a brightly-colored sticker identifying the patient as a cholesterol patient or a sheet of paper on the front of the chart with information about the patient's lipid results, treatment status, or a definitive recommendation for care.1102 Electronic medical records have the potential to prompt (i.e., require) the physician to act on lipid results or needed treatment issues as a part of each office visit.
3) Identify a patient advocate in the office to help deliver or prompt care
Many studies have demonstrated the value of assigning an individual in the office the responsibility of keeping track of the patient's progress, and prompting or augmenting the care provided.1094,1097-1099,1101,1103 In fact, this organizational change may be one of the more powerful ways of advancing preventive care in the average busy office setting. This individual is usually an office nurse who is able to work additional hours to assume this new role; occasionally, new part-time personnel will need to be hired. The advocate reviews the patient chart, extracts critical information, summarizes it and prompts the physician to attend to certain issues, provides patient information and consultation, reinforces treatment plans, and follows up with patients between scheduled visits by phone or e-mail. Most physicians who have worked with a patient advocate recognize the vital importance of this role in providing preventive services.
4) Use patients to prompt preventive care
Physicians typically respond to a patient's request for health services.1096 Using this premise, several programs have given the patient access to information about their lipid disorder not only to inform them, but also to motivate them to request preventive health services.1100 This approach also has the advantage of transferring responsibility for health-seeking behavior into the hands of the patient. An important part of this approach is to identify sources of accurate information the patient can use to learn more about their health. The Web sites of the NCEP and American Heart Association are recommended.
5) Develop a standardized treatment plan to structure care
Some physicians work better if they follow a structured plan or treatment algorithm when providing risk factor management.1104 One advantage of following such a plan is that it is standardized, and should therefore assure consistency and completeness in the care delivered. It should prompt the physician to attend to all key issues during routine follow-up appointments, including evaluation of the patient's adherence with treatment. Of course, following a standardized treatment plan does not mean that the physician cannot deviate from it when needed.
6) Use feedback from past performance to foster change in future care
Routine review of a select number of patient charts can provide important feedback about the care being provided to lipid patients, and prompt improvements in care if needed. Charts selected for this review should be those of high-risk patients, such as individuals with a history of myocardial infarction or diabetes. The audit may be another way of using the services of a patient advocate (discussed above). Key issues to extract from the charts include:
Did the patient have a recent lipid profile?
If the patient qualifies for treatment, was treatment provided?
If treatment was given, is the patient at their LDL goal?
Did the physician document his/her assessment and plans?
Routinely receiving feedback such as this serves to inform the physician about how well he/she is doing with lipid management, and directs attention to ways of enhancing this service. It may also serve as important information for marketing the physician's services to health insurance plans and employer groups.
7) Remind patients of appointments and follow-up missed appointments
Many lipid patients are lost to followup, and thus do not receive the services they require to successfully reduce CHD risk. Every physician's office should have a system of tracking patients to assure that all have return appointments and that follow up is provided to persons who miss appointments. It is important to give patients a followup appointment before they depart the office and to send a reminder card or call about a week before the appointment. It is also recommended that the office nurse or patient advocate be given the opportunity to schedule followup visits with the patient to reinforce education and support treatment adherence. When a patient misses a followup appointment, someone in the office should be given the responsibility of trying to reschedule the patient.
c. Interventions focused on the health delivery system
Interventions that are focused on the health delivery system have also been shown to improve patient adherence. Compared with interventions focused on the patient and physician, these interventions have produced the greatest improvement in patient adherence and have sustained this improvement for a long period of time. Further, they have improved both adherence with treatment and outcomes. Some of the more important of these interventions are summarized below and listed in Table IX.2-1.
1) Provide lipid management through a lipid clinic
Establishment of a lipid clinic makes the most sense in health systems where there are a large number of persons, some of whom have very complicated and unique lipid disorders, such as may be found in large primary care group practices and institutions. For example, lipid clinics are commonplace in many Department of Veterans Affairs Medical System institutions. Lipid clinics are typically run by a supervising physician who has often obtained additional training in managing lipid disorders, and are staffed by pharmacists, nurses, and/or dietitians who provide patient care in a multidisciplinary fashion. Other physicians in the health care system refer selected patients for lipid management. The process of care is frequently well defined by a protocol, and a quality control system gives health care providers feedback on their performance. Patient care goals are clear: get referred patients an effective treatment, give them support to adhere to it, and achieve NCEP treatment goals. Perhaps it is this simplicity of purpose and focus that have resulted in reports of very good adherence by persons with prescribed therapy and achievement of treatment goals.527-529,1105,1106 For example, one lipid clinic which provided care exclusively to CHD patients reported that 100 percent of persons were on lipid-lowering therapy, 97 percent had lipid levels documented in medical records, and 71 percent met their LDL goal of <100 mg/dL.1106 Lipid clinics have easily outperformed the usual care models in lowering LDL and getting persons to their NCEP goal.527,528,1105 However, the lipid clinic is a more expensive model of care527 that may not be available to all patients, but these clinics can be especially valuable for patients with complex lipid disorders.
2) Utilize case management by nurses
Closely related to the lipid clinic concept is case management by nurses. A number of such models have been described in the literature, and compare very favorably to other models of care in terms of treatment outcomes, lipid control, and patient adherence.266,523,525,1080,1107-1109 In these models, some (or all) of the elements of care are provided by specially-trained nurses. In some instances, care is delivered by nurses at the worksite, in the home, or in the community; and in other cases, a clinic or hospital outpatient setting. Often, there is a strong emphasis on lifestyle modification (i.e., smoking cessation, exercise training, weight loss, and nutrition counseling) in addition to lipid-modifying drug therapy. Treatment is often guided by a written protocol. Nurses in these settings deliver care that is typically provided by physicians, including conducting medical histories and physical exams; collecting and interpreting laboratory tests; and selecting and titrating medications. All case management models describe strong patient counseling and follow-up monitoring components. Comparison of nurse case management versus usual care models have shown the nurse care model to be at least equivalent, and in some cases superior, in terms of LDL lowering and achievement of treatment goals. No cost-effectiveness comparisons have been made.
3) Deploy telemedicine
As noted above, phone follow-up of patients between scheduled physician visits has been successfully used to improve adherence.1082,1083,1087 This is a very accessible, relatively inexpensive way to maintain a link with the patients and to manage problems that deter adherence as they arise. Reports indicate that groups using this approach have seen improvement in LDL reduction and achievement of treatment goals.
4) Utilize the collaborative care of pharmacists
Collaborative care by pharmacists is a model in which community pharmacists, working in their pharmacies, collaborate with primary care providers to augment the care provided to persons with lipid disorders. In this model, pharmacists see persons during medication refills or by appointment, to reinforce the importance and purpose of therapy, provide patient education on lifestyle and pharmacologic therapy, emphasize the need for adherence, identify and resolve barriers to adherence, and provide long-term monitoring of drug response and feedback to the patient between visits to the primary care provider. During these visits, pharmacists commonly measure the patient's blood pressure or blood lipids utilizing desktop analyzers. This allows pharmacists to give the patient feedback on their progress and reinforce the steps to achieving treatment goals. Services are documented, and summaries are sent to the patient's primary provider to inform him/her of the pharmacists findings and actions. These models have proved to be among the strongest for maintaining persons on treatment and achieving treatment goals.1110-1112 For example, one study of pharmacists' collaborative care reported that 94 percent of persons persisted on therapy (i.e., stayed on lipid-lowering treatment at least to some degree), 90 percent of persons were considered adherent with prescribed medications, and 63 percent had reached and were maintained at their NCEP LDL goal for a period of two years.1111
5) Execute critical care pathways in hospitals
Use of clinical pathways or other management protocols in hospital settings has resulted in improved adherence to therapy by CHD patients and better cholesterol control.524 The Cardiac Hospitalization Atherosclerosis Management Program (CHAMP) focused on the initiation of therapy with aspirin, beta blocker, ACE inhibitor, statin, diet, and exercise in persons with established CHD prior to hospital discharge.524 The program used post-discharge follow-up visits to titrate the statin dose to achieve an LDL of <100 mg/dL. One year after discharge, 91 percent of persons were being treated with cholesterol-lowering therapy and 58 percent were at treatment goals; these results suggest that initiating treatment during hospitalization for CHD adds needed emphasis to the importance of cholesterol-lowering treatment alongside other cardiac medications.⇓