MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS)

Korey Kennelty

Status

Completed

Conditions

Hypertension

Diabetes

Hyperlipidemia

Cardiovascular Disease

Treatments

Behavioral: CVRS Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02215408

201309828

Details and patient eligibility

About

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

Full description

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.

Enrollment

402 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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