A randomized controlled trial of a physician-directed treatment program for low-income patients with high blood cholesterol: the Southeast Cholesterol Project
T. C. Keyserling, A. S. Ammerman, C. E. Davis, M. C. Mok, J. Garrett and R. Simpson Jr
Department of Medicine, University of North Carolina, Chapel Hill, USA.
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.
