Patient Adherence: Tools for Designing a Customized Program

The problem of patient adherence to prescription medication is a well-documented challenge for patients, healthcare practitioners, managed care organizations and drug makers.  Industry sources claim:

 30 percent of all prescriptions go unfilled

 Less than 50 percent of patients take their medication as prescribed

20 percent of all hospital admissions are attributed to poor complianc

Low health literacy affects an estimated 90 million Americans

Low adherence rates stem from many different reasons, yet are most often attributed to a basic lack of understanding of the disease state, and the health consequences that follow if a condition is not properly treated. On top of this, only 30 percent of patients receive instructions from their physician as to how to take their medication, and of those who do receive instructions, an estimated 60 percent forget verbal information within one hour. Many patients cite affordability issues as reasons for noncompliance while other patients may find the regimen too complicated or the dosing inconvenient.[1]

Given the chances for a treatment regimen to break down, it becomes necessary for drug makers to provide their patients with the education and motivation they need to stay on a drug therapy.

Thus, patient adherence programs—strategic outreach efforts designed to educate patients, provide support to overcome barriers and influence behavior to enhance treatment compliance—are becoming an integral part of product marketing plans.

When is a formal patient adherence program a good idea?

Research overwhelmingly suggests that when patients are actively involved in their healthcare treatment options, the more likely they are to adhere to therapy.

Patient populations with chronic or progressively debilitating symptoms may benefit significantly from supplemental education, intervention or monitoring tools. Additional factors that must be considered include the complexity of the treatment or administration regimens and the level of difficulty involved with insurance coverage requirements. In addition, medications that require prior authorization or special handling by the dispensing pharmacy warrant additional support through a well designed and efficient adherence program. Examples of these diseases include rheumatoid arthritis, psoriasis, diabetes, and depression.  In general, the more complex the disease state, dosage regimen, or delivery method, the more likely an adherence program is a "good idea". When simplifying the regimen is not possible, patient education and communication are essential.[2]

Depending on the complexity of a patient's symptoms, a successful adherence program may be as simple as providing disease state information written for a consumer at the time of prescribing. Or, it may require active intervention from healthcare professionals with patient monitoring at frequent intervals. The key to success typically involves tailoring each intervention to the patients' needs, making it simple and easy to use by the consumer and healthcare practitioner, and adding value to the treatment process.  

Getting Started: program design and initial considerations

A successful program will not only provide information about the disease state, but manage patient expectations about the long-term effects of the condition and the product. Effective program design considers:

Disease state ─ to identify subject matter expert and the timeline for patient "drop-off" points for non-compliance

Patient dynamics─ to identify potential adherence barriers

Product characteristics─ to identify additional non-compliance drivers

Intervention strategies─ to determine appropriate methods and frequency (phone, email, newsletters)  

Market factors─  to assess competitive products and patient population trends

Clinical trial data─ to identify practical compliance issues uncovered in registration trials, reducing reliance on theoretical ideas

The use of stages of change model provides recognition of the changing educational and support needs of patients as they move through a treatment course and provides for tailored patient messaging at these different stages of treatment.

Designing programs according to multi-dimensional criteria comprehensively addresses common barriers and patient health behaviors for more efficiency.

Additionally, a disease state expert or key opinion leader can help define the overall adherence strategy and program objectives while adding credence to garner physician support and patient enrollment.

The Agency for Healthcare Research and Quality (AHRQ) is the lead federal agency charged with improving the quality, safety, efficiency and effectiveness of healthcare for all Americans. As one of 12 agencies within the Department of Health and Human Services, AHRQ supports health services research that will improve the quality of healthcare and promote evidence-based decision-making. AHRQ is a good resource for the design and development of adherence programs.

Program duration will vary according to disease state, which is typically determined by the point of common patient drop-off.  A short-term program may range from 3-6 months while a longer-term one may last up to two years.

The Implementation Process

For conditions that require frequent monitoring from a healthcare provider, a centralized call center model (staffed by pharmacists, nurses or specially-trained support representatives) that provides routine personal contact can be a highly effective tool for patient enrollment, stratification and ongoing management. 

Prospective patients, referred either from their physicians or from direct-to-consumer advertisements, respond to a healthcare call center via toll-free phone number. Patients who meet program criteria are given a health risk assessment questionnaire. This is an instrument used to evaluate and measure general health indicators and identifies how healthcare providers may be able to help a patient coordinate and access the most appropriate therapies. For patient adherence programs, it is typically used to help stratify patients and help define the most cost effective and efficient adherence strategy.

A knowledge-based customer relationship management (CRM) application can serve as the underpinning of the operational model, by facilitating operational logistics and tracking activity.  These applications can be used to collect demographics, schedule and track calls and produce custom communications for patients.

Stratification categorizes patients into high, medium, low risk of death, disease, increased cost or compromised adherence. Stratification methods are disease-specific and typically target identifying co-morbidities (hypertension and smoking), family history or genetic predispositions, concomitant therapies, disease severity or frequency, environmental exposures or risk of non-compliance. Stratification allows for patient groups to receive specific messaging and efficient regimens based on expected levels of intervention.

Barrier assessment vehicles, instruments designed to identify barriers to treatment adherence, provide another layer of customization. Barriers typically fall into these categories:

Patient (fear, low health literacy, disorganization)

Medical (complex medical regimens, side effects, asymptomatic disease)

Healthcare (lack of reimbursement, patient education or support)

It's important to address what barriers may exist and which stages they are likely to occur during patient enrollment. For example, many patients may routinely experience needlephobia as a primary barrier.  Explaining potential side effects of a product before addressing a primary patient barrier is not likely to impact patient motivation.

Following enrollment and stratification, patients receive an initial counseling session with a healthcare provider that prepares patients about the timing of clinical benefit, or how long before the medication takes effect, potential side effects and what strategies patients may employ to manage these side effects. Ongoing intervention and support may involve multiple communication vehicles or patient touch points, including routine phone consultation, email alerts, follow-up letters, interim questionnaires and educational materials. Communication takes place as often as the patient risk level determines necessary.

Healthcare professionals who are trained to elicit information appropriately from patients handle inbound and outbound calls. By providing an environment where a healthcare professional can ask questions and offer potential solutions based on patients' beliefs, values and medical history, the patient benefits through the opportunity to take a more active role in their treatment. Patient and provider can set reasonable goals together; one that makes sense for individual patient lifestyles.

Physician involvement is critical to program success. Patients often opt-in with the recommendation of their physician. Ways to motivate physicians include:

Training on program components and benefits

Delivery of aggregate data that demonstrates overall performance on the program

Provision of best practices documentation or nationally accepted treatment guidelines

Provision of patient-specific feedback (treatment perceptions, satisfaction, compliance issues).

Physicians are most likely to support a program that is rooted in good medicine, easy to use and delivers discernible clinical benefits to their patients.

Metrics: Measuring Program Effectiveness

Program effectiveness can be measured in many different ways. Increases in regional drug sales and patient-reported utilization provide top-level indicators. Other measures of adherence include standard health outcomes indicators, including the number of hospital visits, emergency room visits and days missed from work. These can be supplemented with customized metrics developed specifically for an adherence program. Health assessment questionnaires administered at different stages of the program can measure program effectiveness and adherence patterns. The use of questionnaires for all stakeholders can identify positive and negative learnings, enabling ongoing program component adjustments as needed. Ideal measures involve long-term patient follow up.

The true value of a patient adherence program can extend well beyond the lifetime value of a patient on a therapy. Patient adherence programs help sponsors gain preferred provider status with payors by providing a service that enhances existing physician care, reducing the burden on existing healthcare systems.

Summary

Studies continue to reinforce a conventional wisdom that patients respond positively to open dialogue and information, rather than closed instruction. However, patient education must be personalized to individual needs in order to be most effective and make a lasting impact. A comprehensive strategy that incorporates personal contact and multiple communication vehicles into one platform has proven to be the most effective model in promoting long-term patient adherence.