Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

Completed

• Conditions: Hypercholesterolemia; Coronary Disease; Primary Health Care; Management, Risk
• Interventions: Behavioral: HeartAge intervention

• Registration Number: NCT01242319
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2002-09
• Study Start: 2002-09
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Last Update Submitted: 2010-11-16
• Study First Posted: 2010-11-17
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5218

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 -

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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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multi-modal practice intervention	HeartAge intervention	15 intervention practices receive academic detailing, patient activation computer kiosk, decision supported PDA, and coronary risk factor management toolbox

Primary Outcome Measures

Name	Time	Method
%patients at ATP III goals	one year after intervention	* of patients screened with lipid profiles; * patients at LDL goal; * patients at non-HDL goals

Secondary Outcome Measures

Name	Time	Method
Use on intervention tools	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

Trial Locations

Locations (1)

Memorial Hospital of Rhode Island; 🇺🇸 Pawtucket, Rhode Island, United States