A controlled trial was designed to test the effectiveness of the Heart Health Counts (HHC) program. This patient education program was designed to increase clarity in the cardiovascular risk dialogue, in order to facilitate statin adherence. The primary end point was adherence to filling statin prescriptions during a 120-day period by patients new to statin therapy.
To enroll, patients were asked to complete a consent form, and to complete a survey. Patients were enrolled at the time of a visit to their physician and were eligible to participate if they were at least 40-years of age and receiving a new prescription for statin therapy. Survey items of attitudes and beliefs related to cardiovascular disease and cholesterol management were included.
Identifying patients according to their attitudes concerning health and lifestyle change has been shown to be important in developing strategies to facilitate behavioral change .
Based on their survey responses, patients were categorized into three segments according to their health and medication attitudes: patients who regularly take action to preserve their health, patients committed to their health but not consistently taking action, and patients who do less to preserve health.
Data on statin prescription use from a national pharmacy claims database were used to determine whether or not patients achieved 120 day adherence. Based on region, prescription, age and gender, a control group of similar patients not exposed to the patient education intervention were identified from the national pharmacy claims database. The Western Institutional Review Board approved the study in October of 2006. Patients and physicians completed a consent form agreeing to participate. Physicians also completed a brief survey on their perceptions of the program following use of the brief counseling materials with their patients.
Physicians were eligible to participate if they provided adult primary care or were cardiologists. Physicians were required to read the protocol, to complete a brief online module concerning counseling patients with high cholesterol, and to complete a consent form and letter of agreement. Patients were eligible to participate if they are 40 years of age or older, had received a prescription for a lipid-lowering agent within the past 30 days, had not previously been on a cholesterol-lowering medicine within the past 12 months, were literate in English, and able to give written consent to receive patient educational mailings.
Power calculations indicated, within 95% confidence intervals, a sample including at least 200 patients (including 50 in each of two specific segments, those characterized as Health Preservers and those characterized as Health Commiteds), a total of 100 patients was needed to detect a 5% difference in adherence to statins at 120 days comparing segments to a control group. In order to determine the number of patients required for enrollment, it was estimated that each of the two segments of patients who were ready to act to preserve their health were representative of less than 10% of the total population, and a smaller percentage of these would actually fill their prescriptions. It was further estimated that 200 physicians were needed to each recruit approximately 10 patients with hypercholesterolemia new to statin therapy, a total of 2000 patients. Physicians were each allowed to recruit no more than 15 patients in order to ensure balanced representation among the physicians recruited. Reflecting the 95% confidence intervals, the significance level was set at .05.
Five questions from the 20-question survey were used to segment patients into three groups. These questions were used to create segments, but were not validated for this purpose. Patients were asked to respond to the following statements using a 7-point agreement scale: 1) I feel tired most of the time 2) I feel older than I should 3) I do not care what is in the medication, just that it works 4) I am worried about the long-term side effects of medications and 5) Taking medication makes me feel like I'm doing everything I can to make myself better. Health Preservers were more likely to agree with question #5 and less likely to agree with questions 1,2,3, and 4. Health Committeds were more likely to agree with question 3 but less likely to agree with questions 1, 2 and 5. Others, those patients who were less likely to focus on health preservation, were more likely to agree with questions 1, 2, and 4, and less likely to agree with questions 3 or 5.
Data from a national pharmacy claims database were used to determine adherence to filling statin prescriptions. The average number of days for which statin prescriptions were written was 30 days. However, the number of days for which statin prescriptions were filled varied between sites and depended on the site's current supplies. Therefore, days of filled statin prescriptions were used in this study, rather than the number of prescriptions filled. Two adherence measures were calculated: 1) the average number of days of prescriptions filled for statins per patient during a 120-day time period, and 2) the percentage of patients who filled prescriptions for 120 days of statin therapy.
The HHC program provided tools to physicians to increase clarity in the cardiovascular risk dialogue, in order to facilitate statin adherence. The program was designed to facilitate an enhanced patient-physician dialogue without being labor-intensive for physicians and other healthcare providers. Physicians participating in this study received a counseling kit including 1) a set of 1-minute health manager patient education tools used to describe cholesterol risks, 2) patient contracts or pledges designed to confirm a patient's commitment to the prescribed medical regimen, 3) a copy of the National Cholesterol Education Program pocket guidelines and 4) a set of chart stickers. The materials were designed to address cardiovascular risk and to provide a context for patients who might be presented with a series of lab values but might not have a context for the severity of the risk. The 1-minute health manager and other HHC materials used color coding with green, yellow, and red to represent cardiovascular risk stratification, and to serve as a call to action for patients in the yellow and red zones. By fostering a more constructive patient-provider dialogue, a context could be created for a patient-physician partnership in developing achievable patient goals to reduce the risk of cardiovascular disease.
Following the office visit, patients new to statin therapy received 5 HHC mailings over a 4-month period. The four-color print mailings focused on various aspects of cardiovascular health and cardiovascular risk.
Descriptive statistics for categorical data were expressed as percentages; for the continuous data, the descriptive statistics were expressed as means (standard deviations). T-tests were used to compare the average numbers of days statin prescriptions were filled, and the percentage of patients who completed 120 days of statin therapy. On questions 1 and 4, a reflect and square root transformation was performed to normalize a distribution that differs only moderately from normal. The deviation is more substantial for questions 3 and 5, so we performed a reflect and inverse transformation. Comparisons of segmented groups were quantified by one-way multivariate analysis of variance (MANOVA), followed by post-hoc pairwise comparisons using the Student-Newman-Keuls (SNK) test and the Dunnett T3 test for data sets with unequal variances. Statistical significance was established as p < 0.05. All analyses were conducted using SPSS 16.0 (SPSS, Inc. Chicago, IL).