MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS)
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|ClinicalTrials.gov Identifier: NCT02215408|
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hyperlipidemia Hypertension Cardiovascular Disease||Behavioral: CVRS Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
- 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).
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
|Principal Investigator:||Barry L. Carter, PharmD||University of Iowa|
|Principal Investigator:||Christopher Coffey, PhD||University of Iowa|