Systematic Management of High Cholesterol Utilizing Computer Monitoring

Hypercholesterolemia Clinical Trial

Official title: Management of Hypercholesterolemia Utilizing a Case Management System, Incorporating Computer-Based Decision Support Technology

Status Completed

Clinical Trial Summary

Employing a physician-directed case management system, utilizing a Certified Registered Nurse Practitioner (CRNP) in conjunction with computer-based decision support technology (CDST) will result in significantly lower total cholesterol and a lower low density lipoprotein cholesterol in a group of subjects enrolled in a general medical clinic compared to subjects managed by primary care providers in the usual care group.

Clinical Trial Description

Atherosclerosis affects 7 million patients and causes approximately 50% of all deaths in the United States. A reduction in modifiable risk factors (especially smoking, hypertension and hypercholesterolemia) is associated with a 30% reduction in acute coronary events. Clinically, fewer than 25% of patients achieve this degree of risk reduction because of significant barriers to implementation of effective risk reduction programs and wide variance in the management of hypercholesterolemia.

Recognition that a physician-directed case management system utilizing a certified registered nurse practitioner (CRNP) and computer-based decision support technology (CDST) offers the potential to implement disease management guidelines consistently and effectively is the impetus for this project. This project will demonstrate that enhanced compliance with the National Cholesterol Education Program (NCEP) guidelines can be achieved in a randomized trial conducted in subjects enrolled in a general medical clinic. The way in which hyperlipidemia will be managed is determined by randomization of the PCP providers to either the usual care group or to the intervention group, in which the management of subjects is delegated to the CRNP in conjunction with the CDST, under the supervision of the physician- investigators. Approximately 220 hypercholesterolemic subjects who are eligible for risk reduction according to NCEP guidelines will be recruited in equal numbers from subjects enrolled in the primary care clinic, beginning in 2005.

The physician-directed case management system employed in this project utilizes a management algorithm for lowering LDL-C cholesterol to the goal of less than 70 mg%. Stepwise increases in simvastatin dose to a maximum of 80 mg/day are used. Surveillance of symptoms and laboratory data to detect adverse side effects of the intervention precedes each increase in simvastatin dose. The CRNP will implement the management algorithm and concentrate on subject adherence, which is judged to be an important element in promoting compliance. The CRNP will initiate contact with the subject whenever a decision point is reached in the treatment algorithm, a deviation from the management algorithm occurs or an adverse reaction is detected. The case management model has been shown to be effective in achieving treatment goals in conditions such as hypercholesterolemia and diabetes mellitus.

This study will test hypothesis I, that employing a physician-directed case management system, utilizing a Certified Registered Nurse Practitioner (CRNP) in conjunction with computer-based decision support technology (CDST) will result in significantly lower total cholesterol and a lower low density lipoprotein cholesterol in a group of subjects enrolled in a general medical clinic compared to subjects managed by primary care providers in the usual care group.

A secondary aim of the project is to establish that computer-based decision support technology can be developed that will provide reliable clinical recommendations for the management of type II hyperlipidemia. This proposition will be tested by hypothesis II, that the computer-based decision technology provides advice for management of hyperlipidemia that is comparable to that of a cardiologist in the same institution.

Our physician-directed case-management system is expected to enhance guideline compliance by CDST monitoring of the subject�s compliance and cholesterol response to the management algorithm, thus contributing to improved outcomes for patients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT00133094
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Completion date: December 2007