Cardiovascular DiseasesNCT01610609
Reducing Disparities in Primary Prevention of Cardiovascular Disease
A study testing Population Health Management Intervention in people with Cardiovascular Diseases and Cholesterol, LDL, run by Northwestern University at 3 sites in United States.
Trial summary
Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cholesterol, LDL
- What is being tested?
- Population Health Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men >= 35 and women >= 45 years old
- LDL-C completed in the past 5 years
- Not currently prescribed lipid lowering medication
- >= 1 face to face visit to a study site in the 6 months prior to the start of the study or a visit during the enrollment period
- The 10-year risk of coronary death or myocardial infarction (based on Framingham Risk Score) is at least 10% and the LDL-C is above 100 mg/dL
Who cannot join
- Previously diagnosed with any of the following: coronary disease, peripheral arterial disease, carotid artery disease, abdominal aortic aneurysm, or diabetes mellitus
- Primary language is not English or Spanish
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Near North Health Service Corporation
Chicago, Illinois, 60610
Heartland Health Outreach
Chicago, Illinois, 60645
North Country Health Care
Flagstaff, Arizona, 86004
About this study
Official title: Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease
Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.
Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach.
Read more
Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).
Aim 2: Interview patients who received the intervention to identify barriers to success
Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.
- Conditions
- Cardiovascular Diseases, Cholesterol, LDL
- Being tested
- Population Health Management Intervention
- Keywords
- Statin treatment, Cardiovascular disease, High cholesterol, Care management
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Population Health Management InterventionBehavioural
This intervention includes:
- Care manager led patient education to promote increased patient awareness of personal cardiovascular disease (CVD) risk and
- Care manager led patient outreach to facilitate the treatment of eligible and appropriate patients with statins for primary CVD prevention
| Study group | Role | What they receive |
|---|---|---|
| Population Health Management Intervention | Experimental | Participants randomized to this arm will receive the population health management intervention. Receives: Behavioral: Population Health Management Intervention |
| Usual Care Control Group | No intervention | Participants randomized to this arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discussion between provider and patient about statin treatment
We will use queries of the electronic health record to detect documentation of face-to-face or telephone discussions regarding statin treatment. Physician investigators will be blinded to study group status and categorize variable as YES if there is documentation of any of the following in the chart (1) prescription for a statin (2) recommendation for statin therapy (3) patient refusal of statin (4) discussion of the use of a drug to lower cholesterol.
Measured: within 6 months of randomization
Secondary outcomes (2)
Statin prescription
We will query the electronic health record to determine whether or not a statin was prescribed in the 6 months following randomization
Measured: within 6 months of randomization
Low-density lipoprotein cholesterol (LDL-C)
We will query the electronic health record to determine whether there was a significant lowering of LDL-C defined as a follow up LDL-C >= 30 mg/DL lower than baseline.
Measured: within 1 year of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Stephen Persell, Northwestern University
- Investigators
- Stephen D Persell, MD MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610609
- Sponsor's protocol ID
- 1P01HS021141-01-Project 2
- Other IDs
- 1P01HS021141-01
- Status last verified
- Sep 2014
- First submitted
- 31 May 2012
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karmali KN, Lee JY, Brown T, Persell SD. Predictors of cholesterol treatment discussions and statin prescribing for primary cardiovascular disease prevention in community health centers. Prev Med. 2016 Jul;88:176-81. doi: 10.1016/j.ypmed.2016.04.011. Epub 2016 Apr 16.
PubMed 27090436Persell SD, Brown T, Lee JY, Shah S, Henley E, Long T, Luther S, Lloyd-Jones DM, Jean-Jacques M, Kandula NR, Sanchez T, Baker DW. Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial. Circ Cardiovasc Qual Outcomes. 2015 Nov;8(6):560-6. doi: 10.1161/CIRCOUTCOMES.115.001723. Epub 2015 Nov 10.
PubMed 26555123
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01610609
- Acronym / sponsor ID
- 1P01HS021141-01-Project 2
- Conditions
- Cardiovascular Diseases, Cholesterol, LDL
- Keywords
- Statin treatment, Cardiovascular disease, High cholesterol, Care management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2012 (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.
Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.
Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach.
Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).
Aim 2: Interview patients who received the intervention to identify barriers to success
Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population Health Management Intervention | Experimental | Behavioral: Population Health Management InterventionParticipants randomized to this arm will receive the population health management intervention. |
| Usual Care Control Group | No intervention | –Participants randomized to this arm will receive usual care. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men >= 35 and women >= 45 years old
- LDL-C completed in the past 5 years
- Not currently prescribed lipid lowering medication
- >= 1 face to face visit to a study site in the 6 months prior to the start of the study or a visit during the enrollment period
- The 10-year risk of coronary death or myocardial infarction (based on Framingham Risk Score) is at least 10% and the LDL-C is above 100 mg/dL
Key exclusion criteria (2 listed)
- Previously diagnosed with any of the following: coronary disease, peripheral arterial disease, carotid artery disease, abdominal aortic aneurysm, or diabetes mellitus
- Primary language is not English or Spanish
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 |
|---|---|---|
| Population Health Management InterventionThis intervention includes: * Care manager led patient education to promote increased patient awareness of personal cardiovascular disease (CVD) risk and * Care manager led patient outreach to facilitate the treatment of eligible and appropriate patients with statins for primary CVD prevention | Behavioural | Population Health Management Intervention |
Primary outcome
Discussion between provider and patient about statin treatment
Time frame: within 6 months of randomization
We will use queries of the electronic health record to detect documentation of face-to-face or telephone discussions regarding statin treatment. Physician investigators will be blinded to study group status and categorize variable as YES if there is documentation of any of the following in the chart (1) prescription for a statin (2) recommendation for statin therapy (3) patient refusal of statin (4) discussion of the use of a drug to lower cholesterol.
2 secondary outcomes
Statin prescription
Time frame: within 6 months of randomization
Low-density lipoprotein cholesterol (LDL-C)
Time frame: within 1 year of randomization
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 29 Sep 2014.
- Derived from this study: PubMed 27090436Karmali KN, Lee JY, Brown T, Persell SD. Predictors of cholesterol treatment discussions and statin prescribing for primary cardiovascular disease prevention in community health centers. Prev Med. 2016 Jul;88:176-81. doi: 10.1016/j.ypmed.2016.04.011. Epub 2016 Apr 16.
- Derived from this study: PubMed 26555123Persell SD, Brown T, Lee JY, Shah S, Henley E, Long T, Luther S, Lloyd-Jones DM, Jean-Jacques M, Kandula NR, Sanchez T, Baker DW. Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial. Circ Cardiovasc Qual Outcomes. 2015 Nov;8(6):560-6. doi: 10.1161/CIRCOUTCOMES.115.001723. Epub 2015 Nov 10.
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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.
Stephen D Persell, MD MPH principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Population Health Management Intervention in people with Cardiovascular Diseases and Cholesterol, LDL, run by Northwestern University at 3 sites 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Discussion between provider and patient about statin treatment (time frame: within 6 months of randomization). 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 NCT01610609, which also lists 2 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 29 Sep 2014.