A randomized controlled trial of a physician-directed treatment program for low-income patients with high blood cholesterol: the Southeast Cholesterol Project

OBJECTIVE: To assess the effectiveness of a cholesterol-lowering intervention designed to facilitate the management of hypercholesterolemia by primary care clinicians. DESIGN: Randomized controlled trial, with randomization of clinician-patient groups. SETTING: Twenty-one community and rural health centers in North Carolina and Virginia. PARTICIPANTS: Primary care clinicians (n = 42, 71% physicians) and the patients they enrolled with high cholesterol (n = 372). Twenty-two clinicians were randomized to give the special intervention (184 patients) and 20 to give usual care (188 patients). Two thirds of participating patients were women, 40% were African American, and 11% were Native American. INTERVENTION: A 90-minute tutorial to train clinicians how to use a structured assessment and treatment program (Food for Heart Program) consisting of a brief dietary assessment and three 5- to 10-minute dietary counseling sessions given by the primary care clinician, referral to a local dietitian if the low-density lipoprotein cholesterol (LDL-C) remained elevated at 4-month follow-up, and a prompt for the clinician to consider lipid-lowering medication based on the LDL-C at 7-month follow-up. MAIN OUTCOME MEASURES: Changes in total and LDL cholesterol at 4-month follow-up and averaged over a 1-year follow-up period (4-, 7-, and 12-month follow-up). RESULTS: At 4-month follow-up, total cholesterol decreased 0.33 mmol/L (12.6 mg/dL) in the intervention group and 0.21 mmol/L (8.3 mg/dL) in the control group: the difference was 0.11 mmol/L (4.2 mg/dL) (90% confidence interval CI, -0.02 to 0.24 mmol/L -0.7 to 9.1 mg/dL). The average reduction during the 1-year follow-up period was 0.09 mmol/L (3.6 mg/dL) greater in the intervention group (90% CI, -0.01 to 0.19 mmol/L -0.3 to 7.5 mg/dL). Eight percent of intervention patients were taking lipid-lowering medication at follow-up visits compared with 15% of control patients. In a subgroup analysis restricted to the 89% of returnees who were not taking lipid-lowering medication, the reduction in total cholesterol at 4-month follow-up was 0.14 mmol/L (5.5 mg/dL) greater in the intervention group (95% CI, 0.01 to 0.28 mmol/L 0.3 to 10.7 mg/dL); averaged over 1 year, it was 0.14 mmol/L (5.3 mg/dL) greater (95% CI, 0.03 to 0.24 mmol/L 1.2 to 9.4 mg/dL). Changes in LDL-C were similar. CONCLUSIONS: Total cholesterol and LDL-C decreased more in the intervention group than in the control group. Overall, the difference in lipid reduction between groups was modest and of borderline statistical significance; among participants who did not take lipid-lowering medication during follow-up, the difference in lipid reduction between groups was larger. We conclude that primary care clinicians can be trained to give a cholesterol-lowering intervention to low-income patients that results in modest, short-term reductions in total cholesterol and LDL-C.