MEDication Focused Outpatient Care for Underutilization of Secondary Prevention

Hypertension Clinical Trial

— MEDFOCUS  

Official title:

MEDication Focused Outpatient Care for Underutilization of Secondary Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215408
• Other study ID #: 201309828
• Status: Completed
• Phase: N/A
• Start date: January 20, 2015
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Behavioral:
• CVRS Intervention
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.

Locations

Country	Name	City	State
United States	Texas Tech University Health Science Center	Amarillo	Texas
United States	SUNY-University of Buffalo	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Genesis Health System	Davenport	Iowa
United States	Midwestern University	Downers Grove	Illinois
United States	University of Florida	Gainesville	Florida
United States	Memorial Hermann Hospital System	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Wisconsin	Madison	Wisconsin
United States	Milwaukee Health Services,Inc.	Milwaukee	Wisconsin
United States	Wheaton Franciscan Medical Group	Milwaukee	Wisconsin
United States	Temple University	Philadelphia	Pennsylvania
United States	Idaho State University	Pocatello	Idaho
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Siouxland Medical Education Foundation	Sioux City	Iowa
United States	University of South Florida	Tampa	Florida
United States	Northeast Iowa Medical Education Foundation	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Korey Kennelty

Country where clinical trial is conducted

United States, 

References & Publications (2)

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). pii: e004432. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The average cost per subject, measured in dollars and cents, of implementing the intervention	The cost per subject will include costs for visits to the primary care physician, the cost of prescribed drugs, and the cost for the time spent by study pharmacists communicating with the patient, creating a care plan, and communicating with the patient's primary care provider.	12 months
Secondary	The percent of intervention group patients who rate the intervention as helpful (versus not helpful)	Of the subset of 20 intervention group patients who are interviewed about the study intervention, the percent who state that the intervention was helpful (versus not helpful).	24 months