Systematic Management of High Cholesterol Utilizing Computer Monitoring
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Simvastin; Computer-based decision support technology
Intervention type(s): Drug; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Decision Support Systems, Clinical