Treatment of Hyperlipidemia Part 2

Project ImPACT: Hyperlipidemia

Project ImPACT: Hyperlipidemia is a recently completed community pharmacy-based demonstration project. ImPACT is an acronym for Improve Persistence And Compliance with Therapy. The study began in March 1996 and concluded October 1999. There were four core objectives: 1) improve patient persistence and compliance with lipid-lowering therapy; 2) increase communication and the flow of clinical information among patients, pharmacists, and physicians; 3) improve the cholesterol levels of individual patients over time; and 4) increase the population of patients who reach and maintain their NCEP lipid goals.

A total of 26 pharmacy practice sites in 12 states participated in the study. These sites were chosen based on criteria that addressed the readiness of the pharmacy to provide basic pharmaceutical care services. Readiness was determined by the availability of a private or semiprivate area for patient consultation; technician support; a documentation system for recording, tracking, and reporting patient care interventions; experience with patient-focused disease state management programs; demonstrated communication skills; and the ability to implement point-of-care testing technologies. Fourteen of the pharmacies were independent, three were professional chain stores, one was a chain grocery, two were home health stores, four were clinic pharmacies, and two were managed care or health maintenance organization pharmacies.

Patients were identified through referrals by local physicians, project pharmacists, other healthcare providers, or by self-referral. They were either newly diagnosed with hyperlipidemia or already receiving lipid-lowering drugs but not yet at their target lipid goal. A fasting lipid profile was performed using the LDX Analyzer (Cholestech, Hayward, CA), which requires only a fingerstick blood sample, and results were obtained within five minutes. Initiation of lifestyle modification and pharmacologic therapy was then undertaken by the patient’s physician based on the lipid results. Pharmacists communicated clinical progress — in the areas of cholesterol test results, current health status, coronary artery disease risk, and NCEP goal achievement — to the patients as well as their physicians. Patients were seen monthly for the first three months and quarterly thereafter, and fasting lipid profiles were obtained during each visit. The practice archetype designed for the project was a collaborative care model that allowed flexibility in staffing and types of resources available at the various participating pharmacies. This practice model also established a process for the seamless flow of care data between the patient, pharmacist, and physician. And most importantly, the collaborative care structure organized methods for pharmacists to document, interpret, and report their lipid management interventions.

One of the endpoints of this study, persistence, was defined as a patient who started on medication during the study and remained on the medication as of his or her last study visit. A second study endpoint, compliance, was determined through an evaluation of the number of missed doses for each lipid-lowering medication and of refill timing. Any patient who missed five or more days of medication or who missed a scheduled refill visit by more than five days was judged to be noncompliant for that visit. Compliance as a percentage was calculated by dividing the number of visits at which patients were compliant by the total number of patient visits.

Results: A total of 574 patients were enrolled in the study. Of the 397 patients who completed the two-year study, 345 (86.9%) patients were treated with lipid-lowering medications and lifestyle modifications. The remaining 52 patients (13.1%) focused on lifestyle modifications only (diet and exercise) in an effort to reach target cholesterol goals. The distribution of lipid-lowering drugs used was 89% statins, 5% niacin, 4% fibrates, and 2% bile acid resins. Of the 345 patients started on medication, the medication persistence rate was 93.6%. Of the 2,817 documented visits for patients on medication, the per-visit medication compliance rate was 90.1%. Average fasting lipid levels for patients at the beginning and end of the study are shown in Table 2.

In the primary and secondary prevention groups, NCEP goal achievement at the end of the study was 67.4% and 47.5%, respectively. Furthermore, 248 of all 397 patients (62.5%) were at or below goal as of their last full lipid profile, representing up to a 100% improvement over goal-attaining rates reported in the literature (Figure 1). Finally, of the 346 pharmacist-recommended interventions, physician acceptance of their recommendations was 76.6%.

Figure 1

Persistence, Compliance, and Treatment to NCEP Goal in Dyslipidemic Patients (N=397)