Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Hypercholesterolemia; Primary Health Care; Management, Risk
• Intervention / Treatment: Behavioral: HeartAge intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 5218

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

stratified random sample of practices within those who agreed to participate; Cluster sampling of patients from practices

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multi-modal practice intervention; 15 intervention practices receive academic detailing, patient activation computer kiosk, decision supported PDA, and coronary risk factor management toolbox	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; Other Names: Cholesterol Education and Research Trial
Usual care; 15 practices receive academic detailing reviewing the ATP III cholesterol management guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
%patients at ATP III goals	of patients screened with lipid profiles; patients at LDL goal; patients at non-HDL goals	one year after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Hospital of Rhode Island
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Charles B Eaton, MD,MS, Memorial Hospital of Rhode Island

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.cct.2005.01.002.
• 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. doi: 10.1370/afm.534. Erratum In: Ann Fam Med. 2006 Jul-Aug;4(4):371.
• 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.
• 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. doi: 10.1111/j.1520-037x.2007.07200.x.
• Eaton CB, Parker DR, Borkan J, McMurray J, Roberts MB, Lu B, Goldman R, Ahern DK. Translating cholesterol guidelines into primary care practice: a multimodal cluster randomized trial. Ann Fam Med. 2011 Nov-Dec;9(6):528-37. doi: 10.1370/afm.1297. Erratum In: Ann Fam Med. 2012 Mar-Apr;10(2):179.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Estimate): November 17, 2010
• Last Update Submitted That Met QC Criteria: November 16, 2010
• Last Verified: September 1, 2002

More Information

Terms related to this study

• Keywords: patient activation; quality improvement; implementation trials; cholesterol guidelines
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Coronary Disease; Hypercholesterolemia
• Other Study ID Numbers: 02-01; 1R01HL070804 (U.S. NIH Grant/Contract)