HypercholesterolemiaNCT01242319
Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
An observational study of Hypercholesterolemia and Coronary Disease, run by Memorial Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Coronary Disease, Primary Health Care
- What is being tested?
- HeartAge intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,218 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
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.
Read the 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.
- Being tested
- HeartAge intervention
- Keywords
- quality improvement, implementation trials, cholesterol guidelines, patient activation
- Medical subject headings
- Hypercholesterolemia, Coronary Disease, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartAge interventionBehavioural
Also called Cholesterol Education and Research Trial
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
| Study group | Role | What they receive |
|---|---|---|
| Multi-modal practice intervention | 15 intervention practices receive academic detailing, patient activation computer kiosk, decision supported PDA, and coronary risk factor management toolbox Receives: Behavioral: HeartAge intervention | |
| Usual care | 15 practices receive academic detailing reviewing the ATP III cholesterol management guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
%patients at ATP III goals
- of patients screened with lipid profiles
- patients at LDL goal
- patients at non-HDL goals
Measured: one year after intervention
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startSep 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Charles B Eaton, MD,MS, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242319
- Sponsor's protocol ID
- 02-01
- Other IDs
- 1R01HL070804
- Status last verified
- Sep 2002
- First submitted
- 16 Nov 2010
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15837446Goldman 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.
PubMed 16735521Eaton 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.
PubMed 19288645Parker 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.
PubMed 18174789Eaton 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.
PubMed 22084264
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
- ClinicalTrials.gov ID
- NCT01242319
- Acronym / sponsor ID
- 02-01
- Keywords
- quality improvement, implementation trials, cholesterol guidelines, patient activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,218 participants (actual)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-modal practice intervention | – | Behavioral: HeartAge intervention15 intervention practices receive academic detailing, patient activation computer kiosk, decision supported PDA, and coronary risk factor management toolbox |
| Usual care | – | –15 practices receive academic detailing reviewing the ATP III cholesterol management guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- stratified random sample of practices within those who agreed to participate; Cluster sampling of patients from practices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartAge interventionAlso: Cholesterol Education and Research TrialComputerized 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 | Behavioural | Multi-modal practice intervention |
Primary outcome
%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
1 secondary outcome
Use on intervention tools
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2010.
- Background: PubMed 15837446Parker 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.
- Results publication: PubMed 16735521Goldman 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.
- Results publication: PubMed 19288645Eaton 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.
- Results publication: PubMed 18174789Parker 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.
- Derived from this study: PubMed 22084264Eaton 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.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles B Eaton, MD,MS principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Coronary Disease, run by Memorial Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%patients at ATP III goals (time frame: one year after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242319, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2010.