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HypercholesterolemiaNCT01286311

Tailored Communication to Reduce Cardiovascular Risk

A study testing Direct-to-patient tailored cardiovascular risk message system in people with Hypercholesterolemia and Coronary Artery Disease, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages. Read more about this study

Who is it for?
Ages 40 to 79 years
What is being tested?
Direct-to-patient tailored cardiovascular risk message system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
1 siteUnited States
Study dates
Jan 2011to Jan 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40 to 79 years
  • medication list does not include an active lipid lowering medication
  • the patient does not have a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease
  • the patient has an enrolled study physician recorded as his/her primary care physician
  • the patient has an LDL cholesterol that meets one or more of the criteria listed below.
  • LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%.

Who cannot join

  • Age <40 or >79 years
  • medication list includes an active lipid lowering medication
  • the patient hase a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease
  • the patient does not have an enrolled study physician recorded as his/her primary care physician
  • the patient does not have an LDL cholesterol that meets one or more of the criteria listed below.
  • LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic

    Chicago, Illinois, 60611

Other trials in United States

About this study

The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages. The study will test the hypothesis that that a tailored patient-directed approach to cardiovascular risk reduction integrated into patients' primary care delivery site will improve control of elevated low-density lipoprotein cholesterol and other card iac risk factors more than routine care alone for patients at intermediate or high risk for cardiovascular disease.

Being tested
Direct-to-patient tailored cardiovascular risk message system
Keywords
Health Education, Health Knowledge, Attitudes, Practice, Hypolipidemic Agents/therapeutic use, Patient Education as Topic
Medical subject headings
Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Hypertension, Health Education, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct-to-patient tailored cardiovascular risk message systemBehavioural

    Patient informational mailings

Study groups in NCT01286311
Study groupRoleWhat they receive
Direct-to-patient tailored cardiovascular risk message systemExperimentalEligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
Receives: Behavioral: Direct-to-patient tailored cardiovascular risk message system
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction

    Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline

    Measured: 9 months

Secondary outcomes (4)

  1. Frequency of Clinical Encounters

    This will measure the difference in frequency of clinical encounters in the electronic medical record.

    Measured: 9 months

  2. Medication Prescriptions for Dyslipidemia

    This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.

    Measured: 9 months

  3. Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed

    This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.

    Measured: 9 months

  4. Presence of an Aspirin Prescription

    This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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
Single blind
Who is masked
Participant
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01286311
Sponsor's protocol ID
Reducing CV Risk
Other IDs
K08HS015647
Status last verified
Jan 2015
First submitted
27 Jan 2011
Last updated
9 Feb 2015
Data monitoring committee
Yes

Publications

  • Persell SD, Lloyd-Jones DM, Friesema EM, Cooper AJ, Baker DW. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial. J Gen Intern Med. 2013 Apr;28(4):554-60. doi: 10.1007/s11606-012-2268-1. Epub 2012 Nov 11.

    PubMed 23143672

Questions about this trial

What is this clinical trial studying?

A study testing Direct-to-patient tailored cardiovascular risk message system in people with Hypercholesterolemia and Coronary Artery Disease, run by Northwestern University 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?

The sponsor lists 6 inclusion and 6 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 9 Feb 2015. 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?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction (time frame: 9 months). 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 NCT01286311, which also lists 1 linked publication.

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 9 Feb 2015.

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