The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics

This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS for medical offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. Twenty primary care offices were randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186 represented racial minorities.

Subjects in the intervention arm clinic had regular contact by phone, email or text with a CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with the subject, with the site clinical pharmacist and, as needed, with the site provider to optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS intervention lasted for 12 months.

A complex algorithm was used to calculate the degree to which the subject's care and medical regimen follows national guidelines for reducing the risk of developing cardiovascular risk.

Post-intervention telephone interviews are being conducted with 20 intervention subjects in order to assess their experience with the intervention and barriers and facilitators to the intervention.

Inclusion Criteria:

• English speakers age 55 or greater
• Must have a medical history of at least one of the following:
• Coronary artery disease
• Myocardial infarction
• Stroke
• Transient Ischemic Attack
• Atrial Fibrillation
• Systolic heart failure
• Peripheral vascular disease/claudication
• Carotid artery disease
• Diabetes with either: Low density lipoprotein (LDL) 100 or greater AND/OR systolic blood pressure 140 or higher or diastolic blood pressure 90 or higher

Exclusion Criteria:

• Signs of acute angina, stroke, heart failure or renal failure
• Systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater
• Significant hepatic disease, including: Cirrhosis, Hepatitis B or C infection, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) 3 times control or higher, or total bilirubin 2.0 mg/dl or higher

Individual participant data (IPD) datasets will be created without direct or indirect identifiers and reviewed to make sure that elements cannot be used to potentially identify individual subjects. We will create datasets in transport format and package them along with a copy of the protocol, data dictionaries, and a manual that shows the user how to import the data into their own system. Datasets will include baseline data, interim visit data, ancillary data, procedural based data and outcome data, along with laboratory measurements.

Within 12 months of study completion.

Requests for data will be evaluated by both the Principal Investigator and the study statistician. Investigators requesting access to the data will be asked to complete a data sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.