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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215408
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Korey Kennelty, University of Iowa

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
Diabetes Hyperlipidemia Hypertension Cardiovascular Disease Behavioral: CVRS Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 20, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The mean percent of applicable Guideline Advantage standards of care that are met at 12 months [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215408


Locations
Show Show 18 study locations
Sponsors and Collaborators
Korey Kennelty
Investigators
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Principal Investigator: Barry L. Carter, PharmD University of Iowa
Principal Investigator: Christopher Coffey, PhD University of Iowa
  Study Documents (Full-Text)

Documents provided by Korey Kennelty, University of Iowa:
Study Protocol  [PDF] June 14, 2017


Publications:
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Responsible Party: Korey Kennelty, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02215408    
Other Study ID Numbers: 201309828
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Korey Kennelty, University of Iowa:
Diabetes
Hyperlipidemia
Hypertension
Cardiovascular Disease
Additional relevant MeSH terms:
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Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Cardiovascular Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases