Coronary Artery Disease, Dyslipidemia, Hypercholesterolemia, Hypertension
Conditions
Keywords
Health Education, Health Knowledge, Attitudes, Practice, Hypolipidemic Agents/therapeutic use, Patient Education as Topic
Brief 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.
Interventions
BEHAVIORALDirect-to-patient tailored cardiovascular risk message system
Patient informational mailings
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
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 \<10%.
Exclusion criteria
* 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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction | 9 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Clinical Encounters | 9 months | This will measure the difference in frequency of clinical encounters in the electronic medical record. |
| Medication Prescriptions for Dyslipidemia | 9 months | This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia. |
| Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed | 9 months | 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. |
| Presence of an Aspirin Prescription | 9 months | This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 232 |
| Control | 232 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician did not want outreach sent | 14 | 0 |
Baseline characteristics
| Characteristic | Control | Direct-to-patient Tailored Cardiovascular Risk Message System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 patient participants | 0 patient participants | 0 patient participants |
| Age, Categorical >=65 years | 70 patient participants | 81 patient participants | 151 patient participants |
| Age, Categorical Between 18 and 65 years | 147 patient participants | 137 patient participants | 284 patient participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.2 | 61.3 years STANDARD_DEVIATION 9.4 | 60.7 years STANDARD_DEVIATION 9.4 |
| Gender Female | 50 participants | 49 participants | 99 participants |
| Gender Male | 167 participants | 169 participants | 336 participants |
| Region of Enrollment United States | 232 participants | 232 participants | 464 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction | 11.0 % of patients with major LDL reduction |
| Control | Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction | 11.1 % of patients with major LDL reduction |
p-value: 0.9995% CI: [0.54, 1.86]Generalized Logistic Regression
Secondary
Frequency of Clinical Encounters
This will measure the difference in frequency of clinical encounters in the electronic medical record.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | Frequency of Clinical Encounters | 61.9 % of patients with any office visit |
| Control | Frequency of Clinical Encounters | 56.7 % of patients with any office visit |
p-value: 0.2795% CI: [0.84, 1.85]Generalized Logistic Regression
Secondary
Medication Prescriptions for Dyslipidemia
This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | Medication Prescriptions for Dyslipidemia | 11.9 % of patients with New Rx for LLM |
| Control | Medication Prescriptions for Dyslipidemia | 6.0 % of patients with New Rx for LLM |
p-value: 0.03895% CI: [1.05, 4.32]Generalized Logistic Regression
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.
Time frame: 9 months
Population: Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed | 11.8 percentage of participants |
| Control | Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed | 4.7 percentage of participants |
p-value: 0.1395% CI: [0.73, 10.1]Generalized Logistic Regression
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct-to-patient Tailored Cardiovascular Risk Message System | Presence of an Aspirin Prescription | 3.9 % patients w/aspirin now on med list |
| Control | Presence of an Aspirin Prescription | 1.8 % patients w/aspirin now on med list |
p-value: 0.395% CI: [0.5, 9.5]Generalized Logistic Regression