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Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

NCT ID: NCT01242319

Last Updated: 2010-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia Coronary Disease Primary Health Care Management, Risk

Keywords

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quality improvement implementation trials cholesterol guidelines patient activation

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Multi-modal practice intervention

15 intervention practices receive academic detailing, patient activation computer kiosk, decision supported PDA, and coronary risk factor management toolbox

HeartAge intervention

Intervention Type BEHAVIORAL

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

Usual care

15 practices receive academic detailing reviewing the ATP III cholesterol management guidelines

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Cholesterol Education and Research Trial

Eligibility Criteria

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Exclusion Criteria

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role lead

Principal Investigators

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Charles B Eaton, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Memorial Hospital of Rhode Island

Locations

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15837446 (View on PubMed)

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.

Reference Type RESULT
PMID: 16735521 (View on PubMed)

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.

Reference Type RESULT
PMID: 19288645 (View on PubMed)

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.

Reference Type RESULT
PMID: 18174789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22084264 (View on PubMed)

Other Identifiers

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1R01HL070804

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02-01

Identifier Type: -

Identifier Source: org_study_id