Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01242319
First received: November 16, 2010
Last updated: NA
Last verified: September 2002
History: No changes posted
  Purpose

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 Intervention
Hypercholesterolemia
Coronary Disease
Primary Health Care
Management, Risk
Behavioral: HeartAge intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

Resource links provided by NLM:


Further study details as provided by Memorial Hospital of Rhode Island:

Primary Outcome Measures:
  • %patients at ATP III goals [ Time Frame: one year after intervention ] [ Designated as safety issue: No ]
    • of patients screened with lipid profiles
    • patients at LDL goal
    • patients at non-HDL goals


Secondary Outcome Measures:
  • Use on intervention tools [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Enrollment: 5218
Study Start Date: September 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

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.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242319

Locations
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Investigators
Principal Investigator: Charles B Eaton, MD,MS Memorial Hospital of Rhode Island
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles B. Eaton, MD, MS
ClinicalTrials.gov Identifier: NCT01242319     History of Changes
Other Study ID Numbers: 02-01, 1R01HL070804
Study First Received: November 16, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Hospital of Rhode Island:
quality improvement
implementation trials
cholesterol guidelines
patient activation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Hypercholesterolemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014