The Systems-Based Lipid Management Program (SBLMP)  

The SBLMP is implemented and coordinated by the Dietitian Lipid Management Counselor (DLMC), who has two critical intervention roles: the use of the Lotus Notes tracking system to track condition II pt attainment of NCEP goals and to schedule indicated lipid tests and GNI referrals (both of which are subject to physician veto), and provision of telephone-based behavioral counseling to support and extend the efforts of the physician and the GNI and provide more individualized support. A more detailed description of these activities is provided below. Contact with pts will be primarily by telephone, although mail also will be used as appropriate.

Lotus Notes-Based Tracking System

The tracking system used for monitoring lipid-related activities and providing necessary prompts has been upgraded from the D-BASE system used in WATCH to a software and communication system using Lotus Notes from IBM as described in D.11.1.  Because of its responsiveness to changes in study participants’ data, the Lotus Notes tracking system functions as a watchdog for the SBLMP, automatically flagging any pt who is nearing a deadline for a measurement or intervention (see appendix O). The software also incorporates electronic mail for staff communication. The Lotus Notes system will be linked to the PCHIS system used by Primary Care Medicine, as described in D.9.

Although we will be using sophisticated tracking systems to satisfy the research needs of the study, the clinical part of the tracking system will be easy to use.  Therefore, it can be easily disseminated to non-academic settings. The customized software developed for the proposed project will be one of the products of this study, and will be made available to others at no charge. The only requirement for another site to operate the database system is a Lotus Notes client software package (less than $100 expense) and a low-cost personal computer, and the availability of an individual to maintain the system.

The NCEP guidelines recommend a repeat serum lipid measurement by 3 months. (21) Using the Lotus Notes tracking system linked to laboratory data via PCHIS, pts in condition II who have not had their lipids remeasured by 3 months following the initial physician visit will be contacted directly by the DLMC, a lipid profile scheduled, and the physician notified. Similar monitoring and scheduling also can occur at the 6 and 9 month points. Likewise, SBLMP monitoring and follow-up of these measurements can lead to a referral to the GNI. The physician is notified of scheduled lipid-related activities and can veto any such recommendations.

Note: we have elected to recommend the use of lipid profiles at UMMC, not surrogate total cholesterol measurements as discussed in the NCEP guidelines. (21) At UMMC a full lipid profile is only slightly more costly than a cholesterol alone and provides TG, HDL-C, and LDL-C.

The telephone counseling (TC) intervention

Primary objectives of the TC calls are to:

·        Facilitate at least an initial visit with the pt’s physician

·        Encourage and facilitate attendance at the GNI when appropriate (i.e., top 10% LDL-C right after MD visit; next 15% LDL-C after 3 months if pt did not reach LDL-C goal) by facilitating motivation to change dietary intake.

·        Reinforce and review plan to facilitate the pt’s meeting dietary change goals set.

·        If the pt has not seen the physician, or has not gone to the GNI, or has not set dietary goals, the DLMC will help the pt set dietary goals

·        Address potential barriers to adherence to dietary change goals and set plan for dealing with problems

·        Develop and practice relapse prevention strategies (once change has occurred)

1.      Pts in the top decile of LDL-C (i.e. 40% of pts in study) are recommended for immediate referral to the GNI. In WATCH only 8% of condition III pts were referred to the GNI at the initial visit. For the small proportion of pts referred early the first two TC calls will be oriented towards reinforcing the physician and GNI goals and intervention. Later calls will be oriented towards maintenance of change and relapse prevention.  For the remaining pts in the top decile of LDL-C who are not referred by their physician, the DLMC will refer the pt to the GNI and inform the physician, who can veto the referral.

2.      Some 35% of pts will be at their NCEP goal by the 3 month point (our experience in WATCH) and will not need the GNI. For these pts the TC calls will be utilized to help reinforce the goals set with the physician or to set goals if this has not been done. The later calls will be oriented towards maintenance of change and relapse prevention.

3.      The remaining 25% of pts who will not have reached their NCEP goal will be referred to the GNI by the physician or the DLMC after the 3-month point. For these pts the first two TC calls will be oriented towards reinforcing the physician intervention and goals set with the physician for nutrition change, or helping the pt set dietary goals, with later calls oriented towards reinforcement of the GNI counseling.

TC calls will follow a structured format with extensive flexibility to allow tailoring to individual needs. As noted above, if a pt does not plan to attend the GNI sessions, or, as with the majority of pts, does not yet need to be referred to the GNI because he/she is not in the highest LDL-C decile and/or has not reached the 3 month decision point for GNI referral,  the DLMC will assist the pt to set realistic dietary goals to lower cholesterol.  For these pts, subsequent to the first TC call, a 7DDR will be mailed for discussion at the time of the next call.

Training of Dietitian Lipid Management Counselors (DLMCs) to do TC

The DLMC will be trained in the behavioral and support components included in the TC protocol. The training will be conducted in three two-hour sessions consisting of: (1) a session to teach the core nutrition interventions, pt-centered counseling, theories of change, strategies to help the pt develop a self-efficacy, and problem-solving and relapse prevention strategies; (2) a follow-up session for evaluation and feedback to refine counseling skills, to include role-playing exercises; and (3) use of the tracking procedures being put into place to facilitate the delivery of interventions. As part of session 2 Dr. J. Ockene will listen to a practice TC call conducted by the DLMCs with a trained “participant simulator”. For quality control she also will listen to TC calls monthly for the first two months and then bimonthly through year 2. The DLMC will be told of the “spot checks” on the day that they will occur and informed consent will be obtained from the pt.

Other Support Materials

Videotapes:  All pts in condition II will receive a copy of “A guide to controlling your cholesterol - A lifetime of good eating (AMA Health Heart Series - AMA/Milner-Fenwick), personalized with an introduction by project staff. We have used this 17 minute video, and find it superior to others available. It includes information on the relationship of cholesterol to atherosclerosis, explains the significance of LDL-C and HDL-C, discusses reducing fat, SFA, and cholesterol in the diet; weight loss, and exercise. It includes practical advice on dietary modification. These videotapes would be sent to the pt within I week following the appointment with the physician, or at the time of the initial SBLMP phone call if the physician appointment is delayed. Pts in the GNI also will have available a library of videotapes produced by the GNI program.

Newsletters:  Bimonthly newsletters will be sent to condition II pts. These newsletters will be simi­lar to those we have been pub­lishing for a number of projects, including WATCH (see appendix K for examples), but will be oriented towards the pts and will reinforce other aspects of the intervention.