: The goal of the proposed trial is to test the impact of a novel practice-based intervention, including the use of personal digital assistant (PDA) based decision support, on adherence with a complex clinical practice guideline (CPG) in primary carepractices. We have chosen the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP 111) guideline as it is complex, including screening criteria, risk stratification, and risk-group specific treatment recommendations. This randomized, controlled practice-based trial will test the primary hypothesis that intervention practices will have a net increase in the proportion of screened adults that is treated appropriately with lipid-lowering drug therapy. We will estimate the marginal cost effectiveness of the intervention for this primary endpoint. Other outcomes will include the proportions of patients that is appropriately 1) controlled to low density lipoprotein cholesterol goal, 2) screened, 3) risk-stratified, and 4) counseled regarding therapeutic lifestyle changes. We will explore the intervention effect on disparities in care observed at baseline. The intervention will be delivered at the level of randomization (the practice) and will include academic detailing and training on use of the PDA-based decision support tool. All practices (n=64) will receive usual care, consisting of guideline dissemination, baseline performance feedback, and continuing education. Outcomes will be assessed based on patient level data from baseline and follow-up chart reviews of adult patients (N-20,000) eligible for cholesterol measurement. Appropriate methods will be used to analyze these correlated data. Impact evaluation will be conducted via baseline and follow-up surveys of participating physicians and staff. Process evaluation will be conducted by tracking use of the PDA-based tool. We estimate as many as 48,000 major CHD events could be averted annually in the US with sufficiently improved adherence to ATPIII. If this intervention is successful, electronic decision support tools could be used to facilitate implementation of other complex CPGs. Hence, this innovative strategy holds great promise for making a substantial public health impact through the prevention of CVD and through subsequent translation to other important conditions.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL070742-04
Application #
6949046
Study Section
Special Emphasis Panel (ZHL1-CSR-J (M1))
Program Officer
Einhorn, Paula
Project Start
2002-09-03
Project End
2007-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
4
Fiscal Year
2005
Total Cost
$584,666
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Bertoni, Alain G; Bonds, Denise E; Chen, Haiying et al. (2009) Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial. Arch Intern Med 169:678-86
Barham, Ann Hiott; Goff Jr, David C; Chen, Haiying et al. (2009) Appropriateness of cholesterol management in primary care by sex and level of cardiovascular risk. Prev Cardiol 12:95-101
Rosenberger, Erica L; Goff Jr, David C; Blackwell, Caroline S et al. (2009) Implementing a palm pilot intervention for primary care providers: lessons learned. Contemp Clin Trials 30:321-5
Bonds, Denise E; Hogan, Patricia E; Bertoni, Alain G et al. (2009) A multifaceted intervention to improve blood pressure control: The Guideline Adherence for Heart Health (GLAD) study. Am Heart J 157:278-84
Rosenberger, Erica L; Goff Jr, David C; Davis, Cralen C et al. (2008) Control of blood pressure in North Carolina primary care: baseline data from the GLAD Heart Trial. N C Med J 69:441-6
Ellis, Shellie D; Bertoni, Alain G; Bonds, Denise E et al. (2007) Value of recruitment strategies used in a primary care practice-based trial. Contemp Clin Trials 28:258-67
Bertoni, Alain G; Bonds, Denise E; Steffes, Susan et al. (2006) Quality of cholesterol screening and management with respect to the National Cholesterol Education's Third Adult Treatment Panel (ATPIII) guideline in primary care practices in North Carolina. Am Heart J 152:785-92