By Hall B. Whitworth, Jr., MD in Regulatory

The assessment of patient compliance is very difficult. Many patients may not want to disappoint their physician and will not be completely accurate about their degree of compliance. Other patients are not able to accurately evaluate or do not know their degree of compliance. In one study, 10 percent of patients reported that they were 100 percent compliant with their medication use. Using pill count methods, however, the use of the prescribed medications ranged from 2 percent to 130 percent of the prescribed pills.

Several methods may help to improve patient understanding, memory, and ultimately compliance to medication or recommended diagnostic studies or treatment. One important strategy is to attempt to improve the likelihood of compliance at the very beginning. An explanation of the goals and rationale for therapy using language that the patient can understand also helps to set the stage. Educate the patient on the perceived benefits of diagnostic studies or therapy at the onset, especially if the patient is asymptomatic. Collaborating with the patient may improve adherence to the treatment plan, including frequency and duration of medication intake. Address potential financial limitations or other barriers to lifestyle modifications that may be required. In particular, addressing any misinformation regarding a medical condition or possible side effects at the onset of any treatment recommendations may help to improve compliance. Finally, explain the potential consequences of not following specific medical recommendations.

Additional recommendations at the onset of the recommended treatment include:

• Speak clearly and briefly and be aware of the patient's health language literacy. Emphasize the most important information early, as patients tend to remember more of what is told first
• Repeat the information orally and provide written instructions if appropriate
• Ask the patient to repeat their understanding of the instructions, and if necessary, encourage them to write down these instructions
• Simplify medical regimens using dosage scheduling charts and pill organizers. Try to coordinate medication schedules with the patient's usual daily routine
• Discuss potential side effects as well as the consequences of stopping the medication or not taking the medication properly
• Review the optimal way to report any questions or side effects so that alterations can be made while continuing to maintain a therapeutic benefit
• Provide clear recommendations and expectations for follow-up and any required treatment monitoring. Schedule appropriate follow-up either by telephone or through an office visit

Following the initial diagnostic or treatment recommendations, an organized plan for regular monitoring, continuing education, and patient feedback helps to bolster the likelihood of improved patient compliance.

• Encourage open discussion with the patient regarding potential barriers to treatment or side effects. If the patient elects not to proceed with diagnostic testing, consultations, or continued treatment, the patient should be encouraged to report this decision to the physician in an effort to modify plans for continued care
• Utilize support of nursing, social services, pharmacists, and patient's family members to reinforce compliance and follow-up instructions
• During follow-up evaluation, communicating progress with medical conditions may help to encourage continued compliance. This is particularly important in asymptomatic conditions, such as elevated cholesterol or blood glucose levels
• Follow-up with the patient to confirm completion of diagnostic testing or outside consultation. When such recommendations are given, a prospective notation can be made for office staff to later contact the patient to confirm completion

In some specific situations (i.e., anticoagulation monitoring and treatment), the patient may benefit from a medication adherence contract. This should include an explanation of the use of this medication, potential side effects of altering dose or stopping the medication, potential for interactions with other medications, side effects which should be reported, and instructions on proper monitoring and potential for dosage adjustments. Clear explanation of expected follow-up and monitoring schedule as well as how questions can be answered should be included. A signed copy of this contract should be given to the patient and the patient's family or friend, and placed in the medical record.

There may be some circumstances where, after an informed discussion, the patient elects to decline a particular treatment or test. Certainly it is well within the patient's right to be aware of potential diagnostic or treatment options, but to decline to proceed. In this case, the consideration to include a signed written document indicating "informed refusal" might be included in the medical records. This document should include the indications for the procedure or the medication and overall treatment plan, the risk and benefits of a particular procedure or medication, potential alternative treatment options, the potential consequences for refusing such treatment, and if possible the reason that the patient declines treatment. Any such discussion should be well documented in the medical records and may include a note from a possible third-party witness.

At some point, a patient's continued noncompliance may begin to affect the physician-patient relationship. The patient should be given clear expectations and conditions which need to be met in order to continue active treatment. In some circumstances, a decision to terminate the physician-patient relationship may become necessary.

See part one of this article here.