MEDFOCUS: MEDication Focused Outpatient Care for Underutilization of Secondary Prevention

Sponsor
Korey Kennelty (Other)
Overall Status
Completed
CT.gov ID
NCT02215408
Collaborator
(none)
402
18
2
44.3
22.3
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CVRS Intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
Actual Study Start Date :
Jan 20, 2015
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Patient received usual care from the provider in the local clinic.

Experimental: CVRS Intervention

CVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease.

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.

Outcome Measures

Primary Outcome Measures

  1. The mean percent of applicable Guideline Advantage standards of care that are met at 12 months [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

Secondary Outcome Measures

  1. The average cost per subject, measured in dollars and cents, of implementing the intervention [12 months]

    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.

  2. The percent of intervention group patients who rate the intervention as helpful (versus not helpful) [24 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Gainesville Florida United States 32601
2 University of South Florida Tampa Florida United States 33612
3 Idaho State University Pocatello Idaho United States 83209
4 Midwestern University Downers Grove Illinois United States 60515
5 Genesis Health System Davenport Iowa United States 52803
6 University of Iowa Iowa City Iowa United States 52242
7 Siouxland Medical Education Foundation Sioux City Iowa United States 51104
8 Northeast Iowa Medical Education Foundation Waterloo Iowa United States 50702
9 SUNY-University of Buffalo Buffalo New York United States 14260
10 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27559
11 Temple University Philadelphia Pennsylvania United States 19140
12 Texas Tech University Health Science Center Amarillo Texas United States 79106
13 Memorial Hermann Hospital System Houston Texas United States 77030
14 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
15 University of Utah Salt Lake City Utah United States 84112-5820
16 University of Wisconsin Madison Wisconsin United States 53715
17 Wheaton Franciscan Medical Group Milwaukee Wisconsin United States 53210
18 Milwaukee Health Services,Inc. Milwaukee Wisconsin United States 53212

Sponsors and Collaborators

  • Korey Kennelty

Investigators

  • Principal Investigator: Barry L. Carter, PharmD, University of Iowa
  • Principal Investigator: Christopher Coffey, PhD, University of Iowa

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Korey Kennelty, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT02215408
Other Study ID Numbers:
  • 201309828
First Posted:
Aug 13, 2014
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Korey Kennelty, Assistant Professor, University of Iowa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2021