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| ID | Type | Description | Link |
|---|---|---|---|
| K08HS015647 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct-to-patient tailored cardiovascular risk message system | Experimental | Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct-to-patient tailored cardiovascular risk message system | Behavioral | Patient informational mailings |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Clinical Encounters | This will measure the difference in frequency of clinical encounters in the electronic medical record. | 9 months |
| Medication Prescriptions for Dyslipidemia | This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia. |
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Inclusion 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%.
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%.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Persell, MD, MPH | Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23143672 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct-to-patient Tailored Cardiovascular Risk Message System | Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message. |
| FG001 | Control | Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct-to-patient Tailored Cardiovascular Risk Message System | Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Physicians were not enrolled according to age criteria, and are therefore not included above. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | % of patients with major LDL reduction | 9 months |
|
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Serious and/or other [non-serious] adverse events were not collected/addressed. As a result, no participants were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Direct-to-patient Tailored Cardiovascular Risk Message System | Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen D. Persell, MD MPH | Northwestern University | 312-503-6464 | spersell@nmff.org |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D003324 | Coronary Artery Disease |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| D006266 | Health Education |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. | 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. | 9 months |
| BG002 | Total | Total of all reporting groups |
| Number |
| patient participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Physicians were not enrolled according to gender criteria, and are therefore not included above. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Frequency of Clinical Encounters | This will measure the difference in frequency of clinical encounters in the electronic medical record. | Posted | Number | % of patients with any office visit | 9 months |
|
|
|
|
| Secondary | Medication Prescriptions for Dyslipidemia | This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia. | Posted | Number | % of patients with New Rx for LLM | 9 months |
|
|
|
|
| Secondary | 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. | Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included. | Posted | Number | percentage of participants | 9 months |
|
|
|
|
| Secondary | Presence of an Aspirin Prescription | This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record. | 38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis. | Posted | Number | % patients w/aspirin now on med list | 9 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Eligible patients cared for by physicians randomized to the control group will receive usual care. | 0 | 0 | 0 | 0 |
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| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |