Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

Hypercholesterolemia Clinical Trial

Official title:

Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242319
• Other study ID #: 02-01
• Secondary ID: 1R01HL070804
• Status: Completed
• Phase: N/A
• First received: November 16, 2010
• Last updated: November 16, 2010
• Start date: September 2002
• Est. completion date: August 2008

Study information

• Verified date: September 2002
• Source: Memorial Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This quality improvement trial aims to evaluate whether giving patients information about their coronary heart disease risk via a computer kiosk in the doctors waiting room and providing primary care doctors with a personal digital device with a decision support tool to help with cholesterol management will improve cholesterol management compared to usual care.

Description:

This project will demonstrate and evaluate the translation of the ATP III Cholesterol management guidelines into primary care practice. During phase I, a needs assessment will evaluate barriers and facilitators to implementation of ATP III guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from semi-structured individual interviews of patients and providers and participant observation during pilot testing in 6 primary care practices, three tools will be refined and tailored: a computerized patient activation tool based upon NHLBI web-based 10-year CHD risk score that will be placed in each primary care office's waiting room for patient use; an ATP III interactive guidelines tool for hand held device (PDA) to be used by primary care providers as a decision support tool at the point of care and academic detailing materials consisting of a practice manual, interactive, PowerPoint slides, and practice materials to be used during an academic detailing session. During phase 2, a block, randomized designed cluster trial will be performed with one year of intervention within primary care practices (30 practices/55 providers) throughout the state of Rhode Island and Southeastern New England to test the effectiveness of the materials developed in phase I to improve physician performance around ATP III guideline implementation and to improve clinically relevant outcomes, the percentage of patients with LDL-cholesterol at their ATP III goal. Products for dissemination from this grant will include the results of the focus groups barriers and facilitators to implementation of ATP III guidelines findings, a Medical Abstraction tool for quality of care assessment regarding ATP III guidelines, a refined computerized patient activation tool, a tailored ATP III interactive guideline tool for the PDA, tailored academic detailing materials and results of the randomized clinical trial on the effectiveness of these tools to improve primary care practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5218
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:Practices- within 50 miles of research unit,primary care providers, had at least 20 patients agreeing to have chart audited, agreed to be randomly allocated to the intervention or control.

Patients- age 18-80,expected to survive for at least 2 years,agreed to have limited chart audits - Exclusion Criteria:Practices- specialty practices not primary care, more than 50 miles away, involved in another cholesterol management trial, anticipating closing in the next two years.

Patients- children or adolescents,over the age of 80, dementia,comfort measures only.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia
• Management, Risk
• Primary Health Care

Intervention

Behavioral:
• HeartAge intervention
Computerized kiosk in waiting room with HeartAge risk calculator, PDA based decision support tool regarding hyperlipidemia management, website and tool box with coronary risk reduction tools for smoking cessation, diet and exercise, medication adherence

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Eaton CB, Parker DR, Craft J, McMurray J, Roberts MB, Borkan J, Goldman RE, Ahern DK. Using e-health to improve cholesterol management in primary care practice. J Med Pract Manage. 2009 Jan-Feb;24(4):224-30. — View Citation

Goldman RE, Parker DR, Eaton CB, Borkan JM, Gramling R, Cover RT, Ahern DK. Patients' perceptions of cholesterol, cardiovascular disease risk, and risk communication strategies. Ann Fam Med. 2006 May-Jun;4(3):205-12. Erratum in: Ann Fam Med. 2006 Jul-Aug; — View Citation

Parker DR, Evangelou E, Eaton CB. Intraclass correlation coefficients for cluster randomized trials in primary care: the cholesterol education and research trial (CEART). Contemp Clin Trials. 2005 Apr;26(2):260-7. — View Citation

Parker DR, Gramling R, Goldman RE, Eaton CB, Ahern D, Cover RT, Borkan J. Physicians' perceptions of barriers and facilitators regarding adoption of the National Cholesterol Education Program guidelines. Prev Cardiol. 2008 Winter;11(1):29-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%patients at ATP III goals	of patients screened with lipid profiles; patients at LDL goal; patients at non-HDL goals	one year after intervention	No
Secondary	Use on intervention tools	number of times patient activation computer kiosk was used number of times the PDA decision support tool was used How the decision support tool affected decision making process	one year	No