MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
MEDFOCUS
1 other identifier
interventional
402
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jan 2015
Longer than P75 for not_applicable diabetes
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedStudy Start
First participant enrolled
January 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedJuly 23, 2021
July 1, 2021
2.4 years
July 16, 2014
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point
12 months
Secondary Outcomes (2)
The average cost per subject, measured in dollars and cents, of implementing the intervention
12 months
The percent of intervention group patients who rate the intervention as helpful (versus not helpful)
24 months
Study Arms (2)
Control
NO INTERVENTIONPatient received usual care from the provider in the local clinic.
CVRS Intervention
EXPERIMENTALCVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease.
Interventions
A clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korey Kenneltylead
Study Sites (18)
University of Florida
Gainesville, Florida, 32601, United States
University of South Florida
Tampa, Florida, 33612, United States
Idaho State University
Pocatello, Idaho, 83209, United States
Midwestern University
Downers Grove, Illinois, 60515, United States
Genesis Health System
Davenport, Iowa, 52803, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Siouxland Medical Education Foundation
Sioux City, Iowa, 51104, United States
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702, United States
SUNY-University of Buffalo
Buffalo, New York, 14260, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Texas Tech University Health Science Center
Amarillo, Texas, 79106, United States
Memorial Hermann Hospital System
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84112-5820, United States
University of Wisconsin
Madison, Wisconsin, 53715, United States
Wheaton Franciscan Medical Group
Milwaukee, Wisconsin, 53210, United States
Milwaukee Health Services,Inc.
Milwaukee, Wisconsin, 53212, United States
Related Publications (3)
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.
PMID: 26111939BACKGROUNDCarter 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.
PMID: 27993832BACKGROUNDKennelty K, Coffey CS, Ardery G, Uribe L, Yankey J, Ecklund D, James PA, Vander Weg MW, Chrischilles EA, Christensen AJ, Polgreen LA, Gryzlak B, Carter BL. A cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics. J Am Coll Clin Pharm. 2021 Oct;4(10):1287-1299. doi: 10.1002/jac5.1497. Epub 2021 Jul 2.
PMID: 37265855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry L. Carter, PharmD
University of Iowa
- PRINCIPAL INVESTIGATOR
Christopher Coffey, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 16, 2014
First Posted
August 13, 2014
Study Start
January 20, 2015
Primary Completion
June 30, 2017
Study Completion
September 30, 2018
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Within 12 months of study completion.
- Access Criteria
- 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.
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.