The American Journal of Managed Care October 2006
Low-density Lipoprotein Cholesterol Goal Attainment Among High-risk Patients: Does a Combined Intervention Targeting Patients and Providers Work?
Background: Physicians are aware of the National Cholesterol Education Program guidelines; however, most patients fail to attain cholesterol goals.
Objective: To determine whether a combined program of patient education and provider awareness could improve the National Cholesterol Education Program goal attainment among patients at high risk for cardiovascular events.
Methods: One hundred seven high-risk patients with cardiovascular disease were educated in a single 15-minute session regarding their cholesterol levels, risk factors, and medication adherence. Those with scores of 2 or lower on the Morisky questionnaire were classified as low-adherence patients, and those with scores of 3 or higher were classified as high-adherence patients. Seven physicians were provided this information and were requested to evaluate the dyslipidemia management of these patients. Lipid levels were re-evaluated 8 to 12 weeks after the intervention.
Results: At the start of the study, 38 (35.5%) of the 107 patients were at target low-density lipoprotein cholesterol (LDL-C) levels, and 64 of the 107 patients (59.8%) were at target levels after the intervention. High-adherence patients decreased their LDL-C levels from a mean of 118.6 mg/dL (3.07 mmol/L) to 98.6 mg/dL (2.55 mmol/L); low-adherence patients increased their LDL-C levels after the intervention from 134.5 mg/dL (3.48 mmol/L) to 142.1 mg/dL (3.68 mmol/L). A comparison between the LDL-C goal achievers vs nonachievers revealed a significant difference in adherence (P = .001). Among the goal achievers, significant decreases in preintervention vs postintervention total cholesterol levels (P = .001) and LDL-C levels (P = .001) were also noted.
Conclusion: This study demonstrates that an intervention simultaneously targeting patients and providers is successful in improving goal attainment among high-risk patients.
(Am J Manag Care. 2006;12:589-594)
Although physicians are aware of the National Cholesterol Education Program (NCEP) guidelines and attempt to achieve cholesterol goals with their dyslipidemic patients, most patients fail to attain cholesterol goals.1,2 The Lipid Treatment Assessment Project demonstrated that, at best, only 38% of patients achieved the NCEP Adult Treatment Panel II low-density lipoprotein cholesterol (LDL-C) goals; success rates were lowest among the patients who could benefit the most from therapy (18% of patients with coronary heart disease).3 Despite long-standing efficacy data for managing dyslipidemias, a significant gap remains between widely accepted evidence-based treatment guidelines and routine clinical practice.3-8 The recent NCEP Adult Treatment Panel III guidelines call for more aggressive diagnosis and treatment of hyperlipidemia and have increased the number of persons considered to be at high risk for coronary artery disease (CAD).9 LDL-C plays a major role in initiating the development of atherosclerotic plaque. Therefore, the NCEP has established LDL-C as the primary target of therapeutic intervention. The LDL-C goal is the primary objective of therapy for all patients, except for those with triglyceride levels greater than 500 mg/dL (5.65 mmol/L). In these patients, targeting triglyceride levels becomes the primary goal.
As primary care physicians, our challenge is to identify high-risk patients and to be more aggressive in our efforts to achieve the Adult Treatment Panel III goals. This study was conducted to determine whether a combined program of patient education and provider awareness could improve the NCEP goal attainment among patients at high risk for cardiovascular events.
This was a prospective pre-post evaluation of a cohort of high-risk patients with cardiovascular disease. These included patients with CAD or a CAD-risk equivalent (ie, patients with diabetes mellitus, multiple risk factors that confer a 10-year risk for CAD >20%, or other clinical forms of atherosclerotic disease [peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease] as defined by the NCEP Adult Treatment Panel III).9 Based on the NCEP guidelines, LDL-C improvement was the primary target of our intervention. This study was approved by the institutional review board. The medical records of all patients visiting an inner-city clinic associated with a major teaching hospital were reviewed during 6 months from November 2003 to May 2004. A priori, it was determined that a minimum of 78 high-risk patients were needed for the study to obtain a 90% confidence interval with a margin of error of +10% to detect a 15% postintervention increase in goal attainment. Consent was obtained from all patients who agreed to participate and who met study enrollment criteria. Patients younger than 18 years were excluded from the study.
Data collected during the initial visit comprised demographics, such as age, race/ethnicity, height, weight, and waist circumference, and cardiovascular risk factors, such as the presence of hypertension, diabetes mellitus, CAD, peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, and smoking history. Baseline laboratory information recorded included lipid fractions and liver function test results in all patients, as well as glycosylated hemoglobin in patients with diabetes mellitus. Treatment details obtained included the total number of medications taken by the patient, as well as specifics about lipid-lowering agents. Lipid-level goals, as recommended by the NCEP Adult Treatment Panel III guidelines, were defined as follows: LDL-C goal of less than 100 mg/dL (<2.59 mmol/L), triglycerides less than 150 mg/dL (<1.70 mmol/L), non-high-density lipoprotein cholesterol (non-HDL-C) less than 130 mg/dL (<3.37 mmol/L), and HDL-C of 40 mg/dL or higher (=1.04 mmol/L).3 Follow-up lipid values were obtained 8 to 12 weeks after the initial intervention.
Morisky Adherence Scale
The patients completed a Morisky questionnaire to evaluate medication adherence.10 The Morisky score was calculated by tallying the number of "no" answers to the 4 Morisky survey questions of nonadherence. For the purpose of this study, those with scores of 2 or lower were classified as low-adherence patients, and those with scores of 3 or higher were classified as highadherence patients.
One hundred forty-one high-risk patients were educated individually in a single 15-minute session by a trained research assistant who provided information to patients about cholesterol content of food, a low-cholesterol diet, the importance of medication adherence, and risks associated with hyperlipidemia. Before their encounter with the physician, the patients were also given a printout with their current lipid fractions and their target lipid levels.
Information on the patient's current lipid profile and the percentage LDL-C reduction needed to achieve target levels were placed in the front of the patient's medical chart. Physicians were given information about the patient's level of adherence based on the Morisky survey. Statin dosing cards were also provided to the physicians to assist them with initiating and intensifying therapy according to the dose and the corresponding expected LDL-C reduction as listed in the product package inserts. Physicians were then asked to evaluate the dyslipidemia management during this visit among these patients and to fill out a form listing whether they had made any dietary recommendations or lipid medication changes for these patients. Followup lipid levels and liver function test results on these patients were obtained during their scheduled clinic visit 8 to 12 weeks after the intervention.
The data obtained were coded, entered into a data file, and analyzed using SPSS for Windows version 7.0 (SPSS Inc, Chicago, Ill). For the purpose of analysis, the patients were grouped as LDL-C goal achievers (>100 mg/dL [>2.59 mmol/L] before and =100 mg/dL [=2.59 mmol/L] after the intervention) or nonachievers (>100 mg/dL [>2.59 mmol/L] before and >100 mg/dL [>2.59 mmol/L] after the intervention). Continuous data (age, body mass index, blood pressure, number of medications, glycosylated hemoglobin, and lipid profile) of the 2 groups were compared using t test, and categorical data (sex, race/ethnicity, education, treatment, adherence, and concomitant diseases) were compared using ?2 test. Baseline and end-of-study changes in the lipid profiles among LDLC goal achievers and nonachievers were analyzed using paired t test. Results are presented as the mean + SD or as number (percentage). Statistical significance for all tests was established at a nominal P < .05.
One hundred sixty high-risk patients who were being treated by the 7 providers in the clinic were identified for the study. Of these, 141 were enrolled, and 19 patients declined to participate. Among the enrollees, 107 who had follow-up lipid test results after the intervention were considered in the final analysis.
Table 1 summarizes the patient demographics and the baseline laboratory data for the 141 enrolled patients. The mean age was 59.6 years, 89.4% were African American, and 75.9% were female. One hundred thirteen patients (80.1%) were taking lipid-lowering medications at the start of the study. The group had a mean systolic blood pressure of 138.7 mm Hg, diastolic blood pressure of 79.1 mm Hg, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 34.6; 117 (83.0%) were classified as high-adherence patients. The baseline lipid values of the cohort were as follows: total cholesterol, 196.2 mg/dL (5.08 mmol/L); LDL-C, 116.2 mg/dL (3.01 mmol/L); HDL-C, 51.4 mg/dL (1.33 mmol/L); and triglycerides, 143.8 mg/dL (1.62 mmol/L).
Achievement of Lipoprotein Targets
Preintervention and postintervention data were obtained in an intention-to-treat analysis of the 141 enrolled patients. The respective preintervention and postintervention levels were 202.1 ± 68.3 mg/dL (5.23 + 1.77 mmol/L) and 183.3 ± 60.5 mg/dL (4.75 ± 1.57 mmol/L) for total cholesterol (P < .001), 196.2 ± 63.1 mg/dL (5.08 ± 1.63 mmol/L) and 181.7 ± 55.9 mg/dL (4.71 ± 1.45 mmol/L) for LDL-C (P < .001), 51.4 ± 14.8 mg/dL (1.33 ± 0.38 mmol/L) and 50.6 ± 14.6 mg/dL (1.31 ± 0.38 mmol/L) for HDL-C (P = .28), and 143.8 ± 111.6 mg/dL (1.62 ± 1.26 mmol/L) and 133.6 ± 70.6 mg/dL (1.51 ± 0.80 mmol/L) for triglycerides (P = .24).
Of 107 patients who returned for follow-up, 38 (35.5%) were at their LDL-C target at the start of the study and 64 (59.8%) were at their target at the end of the study, resulting in a 24.3% increase in the number of patients at target levels (P < .01). Among 107 patients (Figure), the respective preintervention and postintervention levels were 202.1 ± 68.3 mg/dL (5.23 ± 1.77 mmol/L) and 183.3 ± 60.5 mg/dL (4.75 ± 1.57 mmol/L) for total cholesterol (P < .001), 120.8 ± 53.8 mg/dL (3.13 + 1.39 mmol/L) and 106.5 ± 50.0 mg/dL (2.76 ± 1.30 mmol/L) for LDL-C (P = .001), 51.8 ± 15.9 mg/dL (1.34 ± 0.41 mmol/L) and 50.9 ± 15.7 mg/dL (1.32 ± 0.41 mmol/L) for HDL-C (P = .29), and 147.9 ± 122.6 mg/dL (1.67 ± 13.9 mmol/L) and 134.7 ± 72.3 mg/dL (1.52 ± 0.83 mmol/L) for triglycerides (P = .25).
Based on the Morisky questionnaire, 82.2% of the cohort of 107 were classified as high-adherence patients and 17.8% as low-adherence patients. Among low-adherence patients, LDL-C levels increased after the intervention from 134.5 ± 88.32 mg/dL (3.48 ± 2.29 mmol/L) to 142.1 ± 87.1 mg/dL (3.68 ± 2.26 mmol/L) (P = .35); among high-adherence patients, LDL-C levels decreased after the intervention from 118.6 ± 44.4 mg/dL (3.07 ± 1.15 mmol/L) to 98.6 + 35.2 mg/dL (2.55 + 0.91 mmol/L) (P < .001).
Characteristics of LDL-C Goal Achievers and Nonachievers
The 69 patients who were not initially at their LDL-C goal were analyzed as a subgroup; the 37 patients who achieved goal at the end of the study were compared with the 32 patients who did not achieve goal. There were no differences between the 2 groups in education, body mass index, diabetic control, or blood pressure control. The goal achievers were significantly older than the nonachievers (P = .02). At baseline, the goal achievers were taking a greater number of medications compared with the nonachievers (P = .08).