Atrial Fibrillation, Coronary Artery Disease, Diabetes Mellitus, Hypertension, Stroke
Conditions
Keywords
Diabetes, High Blood Pressure, High Cholesterol, Heart Irregularity, Stroke
Brief summary
The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.
Detailed description
The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities. This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.
Interventions
OTHERPHCVRS Intervention
A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including: 1. Contact via email, phone or text every 2-4 weeks 2. Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease. 3. Collaborative communication with the participant's physician to address gaps in screening or therapy, update medication list, and recommend medication changes. Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk.
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Sponsors
Korey Kennelty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Section A: Demographic Criteria 1. Patient was seen in your clinic or practice at least once in the past 24 months 2. English-speaking male or female 3. Age is 50 or older at medical record screening Section B: Risk Factors - Must have at least one of the following conditions 4. Uncontrolled diabetes (Hemoglobin A1c \> or + 7.5) 5. Elevated LDL cholesterol \> 110 for patients with PAD, CAD, stroke or diabetes or \> 140 otherwise 6. Elevated blood pressure with: * Systolic BP \>= 140 or Diastolic BP \>=90 in persons with diabetes or chronic kidney disease OR * Systolic BP \>= 150 in persons with uncomplicated hypertension Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE 7. History of coronary artery disease 8. Previous Heart Attack 9. History of Stroke 10. History of Transient Ischemic Attack 11. History of Atrial fibrillation 12. History of Peripheral Vascular Disease / claudication 13. History of carotid artery disease 14. Current smoker 15. Obesity with BMI \> 30
Exclusion criteria
Section D:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. | 12 months for each participant | The primary outcome measure was adherence to the GA criteria as a surrogate for quality of care because each subject had varying gaps in guideline-concordant care, depending on their specific cardiovascular conditions and preventative care needs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c. | 12 months for each participant | Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline. |
Countries
United States
Outcome results
None listed