N/A
Completed N=464
Tailored Communication to Reduce Cardiovascular Risk
Source: ClinicalTrials.gov NCT01286311 ↗Enrolled (actual)
464
Serious AEs
—
Results posted
Feb 2015
Primary outcomePrimary: Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction — 11.0; 11.1 % of patients with major LDL reduction — p=0.99
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction |
11.0; 11.1 | 0.99 |
| SECONDARY Frequency of Clinical Encounters |
61.9; 56.7 | 0.27 |
| SECONDARY Medication Prescriptions for Dyslipidemia |
11.9; 6.0 | 0.038 sig |
| SECONDARY Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed |
11.8; 4.7 | 0.13 |
| SECONDARY Presence of an Aspirin Prescription |
3.9; 1.8 | 0.30 |
Eligibility Criteria
Inclusion Criteria
- 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 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%.
Data sourced from ClinicalTrials.gov (NCT01286311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.