The primary aim of this study is to implement and evaluate the effects of a systems-based nutritional intervention program for the patients of primary care internists on dietary intake of saturated fatty acids (SFA) and on serum low density lipoprotein cholesterol levels (LDL-C). In this two-condition randomized clinical trial, the Intervention condition is a systems-based intervention added to a previously developed and found-to-be-efficacious physician-delivered nutrition intervention training and office support program, which serves as the Control condition in this study. The patient (pt) is the unit of randomization and analysis.

The study population is primary care internists and 1200 of their pts with serum LDL-C levels in the highest quartile. The study was conducted in the primary care practices of the University of Massachusetts Medical Center (UMMC). The Systems-Based Lipid Management Program (SBLMP) delivered to pts in the Intervention condition (Cond II) was implemented and coordinated by a Registered Dietitian Lipid Management Counselor (DLMC), utilizing an innovative tracking system with Lotus Notes “groupware” interface to track pt attainment of NCEP goals and to schedule indicated lipid tests and group nutrition intervention (GNI) program referrals, and to provide telephone-based behavioral counseling to support and extend the efforts of the physician. The GNI program is similar to that used in a previous study, and was made available to both study conditions. However, only condition II pts were automatically referred and reinforced by the DLMC. Condition II pts also were also provided with other support materials (videotapes, audiotapes and monthly newsletters).

The underlying concept of the research is the creation of a cost-effective program that builds on and reinforces the physician’s initial intervention, in a programmed manner, so that the care paradigm shifts to a situation where the physician must take a positive step to stop an action such as referral to the GNI, as opposed to the usual situation where the physician must take the step to initiate such an action.

This study extends the findings of the Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH; RO1-HL44492), in which a “patient-centered” physician-delivered counseling intervention, accompanied by an office support program, resulted at one year of follow-up in significant beneficial changes in pts’ diet, weight, and blood lipid levels, (1) and that an efficient dietitian-based GNI program, when utilized, adds substantially to this effect (2). Unlike WATCH, however, because this study investigates the effect of a system that is transparent to the physician, it can be randomized at the level of the individual.

The primary outcomes which evaluated are the following:

• 1. changes in pts' consumption of SFA, and;
• 2. changes in pts' serum LDL-C levels

Additional products of the study include the following:
• A tested model of a physician-delivered, systems-augmented intervention program that integrates physician intervention and multiple non-physician components to assist pts in the upper quartile of the LDL-C distribution to change their eating patterns and lower their LDL-C levels. This model is packaged in an implementation manual for use in other large healthcare settings, and includes software and communications components to facilitate transportability to non-academic settings.
• An assessment of the cost and cost-effectiveness of this model and of the control intervention.