An interventional study of Direct-to-patient tailored cardiovascular risk message system in Hypercholesterolemia, Coronary Artery Disease and Dyslipidemia, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-02-09.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 464 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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%.
Exclusion Criteria:
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%.
Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
Behavioral: Direct-to-patient tailored cardiovascular risk message system
Patient informational mailings
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
Time frame: 9 months
Frequency of Clinical Encounters
This will measure the difference in frequency of clinical encounters in the electronic medical record.
Time frame: 9 months
Medication Prescriptions for Dyslipidemia
This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
Time frame: 9 months
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.
Time frame: 9 months
Presence of an Aspirin Prescription
This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.
Time frame: 9 months
Physicians were recruited at their clinic offices in January 2011. They provided written informed consent to be randomized and to have study staff mail risk messages directly to patients on their behalf if they were randomized to the intervention. Patients were included with a waiver of consent.
| Milestone | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Started | 232 | 232 |
| Completed | 218 | 232 |
| Not completed | 14 | 0 |
| Withdrew: Physician did not want outreach sent | 14 | 0 |
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
| % of patients with major LDL reduction | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction | 11.0 | 11.1 |
This will measure the difference in frequency of clinical encounters in the electronic medical record.
| % of patients with any office visit | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Frequency of Clinical Encounters | 61.9 (0 to 2) | 56.7 (0 to 1) |
This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
| % of patients with New Rx for LLM | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Medication Prescriptions for Dyslipidemia | 11.9 | 6.0 |
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.
| percentage of participants | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed | 11.8 | 4.7 |
This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.
| % patients w/aspirin now on med list | Direct-to-patient Tailored Cardiovascular Risk Message System | Control |
|---|---|---|
| Presence of an Aspirin Prescription | 3.9 | 1.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | — | — | — |
| Control | — | — | — |
218 patients (of the 14 physician randomized to the intervention) and 217 patients (of the 15 physician randomized to the intervention) participated in the study.
| Age, Categorical(patient participants) | Direct-to-patient Tailored Cardiovascular Risk Message System | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 137 | 147 | 284 |
| >=65 years | 81 | 70 | 151 |
| Age, Continuous(years) | Direct-to-patient Tailored Cardiovascular Risk Message System | Control | Total |
|---|---|---|---|
| Mean | 61.3 ± 9.4 | 60.1 ± 9.2 | 60.7 ± 9.4 |
| Gender(participants) | Direct-to-patient Tailored Cardiovascular Risk Message System | Control | Total |
|---|---|---|---|
| Female | 49 | 50 | 99 |
| Male | 169 | 167 | 336 |
| Region of Enrollment(participants) | Direct-to-patient Tailored Cardiovascular Risk Message System | Control | Total |
|---|---|---|---|
| United States | 232 | 232 | 464 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Northwestern University