Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133094
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-08-18
Brief Title:
Systematic Management of High Cholesterol Utilizing Computer Monitoring
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Management of Hypercholesterolemia Utilizing a Case Management System Incorporating Computer-Based Decision Support Technology
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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 subjects compliance and cholesterol response to the management algorithm thus contributing to improved outcomes for patients
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 mgday 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 subjects compliance and cholesterol response to the management algorithm thus contributing to improved outcomes for patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00262 | None | None | None |