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Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242319
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 17, 2010
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Memorial Hospital of Rhode Island

Brief 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.

Condition or disease Intervention/treatment
Hypercholesterolemia Coronary Disease Primary Health Care Management, Risk 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.

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Study Type : Observational
Actual Enrollment : 5218 participants
Time Perspective: Prospective
Official Title: Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
Study Start Date : September 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

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 Name: Cholesterol Education and Research Trial

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

Primary Outcome Measures :
  1. %patients at ATP III goals [ Time Frame: one year after intervention ]
    • of patients screened with lipid profiles
    • patients at LDL goal
    • patients at non-HDL goals

Secondary Outcome Measures :
  1. Use on intervention tools [ Time Frame: one year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
stratified random sample of practices within those who agreed to participate; Cluster sampling of patients from practices

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242319

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United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Charles B Eaton, MD,MS Memorial Hospital of Rhode Island
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Charles B. Eaton, MD, MS Identifier: NCT01242319    
Other Study ID Numbers: 02-01
1R01HL070804 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: September 2002
Keywords provided by Memorial Hospital of Rhode Island:
quality improvement
implementation trials
cholesterol guidelines
patient activation
Additional relevant MeSH terms:
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Coronary Disease
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases