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A Randomized Controlled Trial of a Physician-Directed Treatment Program for Low-Income Patients With High Blood Cholesterol: The Southeast Cholesterol Project
Thomas C. Keyserling, MD, MPH;
Alice S. Ammerman, DrPH, RD;
C. E. Davis, PhD;
Mario Chen Mok, MS;
Joanne Garrett, PhD;
Ross Simpson, Jr, MD, MPH
Arch Fam Med. 1997;6(2):135-145.
Abstract
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Objective
To assess the effectiveness of a cholesterollowering 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 mmoI/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 lipidlowering 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 cholesterollowering intervention to low-income patients that results in modest, short-term reductions in total cholesterol and LDL-C.
Author Affiliations
From the Departments of Medicine (Drs Keyserling, Garrett, and Simpson), Nutrition (Dr Ammerman), and Biostatistics (Dr Davis and Mr Chen Mok), University of North Carolina, Chapel Hill.
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