Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Study Overview
=================
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.

Official Title
-----------------
Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Conditions
-----------------
Diabetes Mellitus, Hypertension, Coronary Artery Disease, Atrial Fibrillation, Stroke

Intervention / Treatment
-----------------
* Other: PHCVRS Intervention
* Other: Personal Health Record


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Section A: Demographic Criteria Patient was seen in your clinic or practice at least once in the past 24 months English-speaking male or female Age is 50 or older at medical record screening Section B: Risk Factors - Must have at least one of the following conditions Uncontrolled diabetes (Hemoglobin A1c > or + 7.5) Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise 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 History of coronary artery disease Previous Heart Attack History of Stroke History of Transient Ischemic Attack History of Atrial fibrillation History of Peripheral Vascular Disease / claudication History of carotid artery disease Current smoker Obesity with BMI > 30 EXCLUSION CRITERIA Section D: Exclusion Criteria - has NONE of the following: Inability to give informed consent Pregnant Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK) Cancer diagnosis with a life expectancy estimated less than 2 years Residence in a nursing home or diagnosis of dementia No telephone or a hearing impairment not allowing them to use a phone Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM Patient has plans to move from the area or transfer care to a different clinic in the next 12 months Omron blood pressure cuff cannot be used on patient's arm for any reason

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHCVRS intervention<br>Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease. | Other: PHCVRS Intervention<br>* A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including: Contact via email, phone or text every 2-4 weeks Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease. 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.<br>Other: Personal Health Record<br>* Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions<br>|
| Other: Usual care/Personal Health Record<br>Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions. | Other: Personal Health Record<br>* Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. | 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. | 12 months for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c. | Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline. | 12 months for each participant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, High Blood Pressure, High Cholesterol, Heart Irregularity, Stroke