Clinical trial NCT02215408: MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
Official title: MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hyperlipidemia
Hypertension
Cardiovascular Disease
Keywords: Diabetes
Hyperlipidemia
Hypertension
Cardiovascular Disease
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 402
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: The average cost per subject, measured in dollars and cents, of implementing the intervention
timeFrame: 12 months
measure: The percent of intervention group patients who rate the intervention as helpful (versus not helpful)
timeFrame: 24 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Pocatello
country: United States
facility: Idaho State University
state: Idaho
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
city: Davenport
country: United States
facility: Genesis Health System
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Medical Education Foundation
state: Iowa
city: Waterloo
country: United States
facility: Northeast Iowa Medical Education Foundation
state: Iowa
city: Buffalo
country: United States
facility: SUNY-University of Buffalo
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Amarillo
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital System
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Wheaton Franciscan Medical Group
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee Health Services,Inc.
state: Wisconsin
Study officials:
affiliation: University of Iowa
name: Barry L. Carter, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Christopher Coffey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carter BL, Coffey CS, Chrischilles EA, Ardery G, Ecklund D, Gryzlak B, Vander Weg MW, James PA, Christensen AJ, Parker CP, Gums T, Finkelstein RJ, Uribe L, Polgreen LA; MEDication Focused Outpatient Care for Underutilization of Secondary Prevention Trial Investigators. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy. 2015 Jul;35(7):653-62. doi: 10.1002/phar.1603. Epub 2015 Jun 25.
citation: Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.