Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Coronary Artery Disease; Hypertension; Atrial Fibrillation; Stroke

• Registration Number: NCT01983813
• Lead Sponsor: Korey Kennelty

Brief Summary

The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.

Detailed Description

The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Study Start: 2014-03-19
• Primary Completion: 2016-11
• Study Completion: 2018-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-10
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.	12 months for each participant	The primary outcome measure was adherence to the GA criteria as a surrogate for quality of care because each subject had varying gaps in guideline-concordant care, depending on their specific cardiovascular conditions and preventative care needs.

Secondary Outcome Measures

Name	Time	Method
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.	12 months for each participant	Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.

Trial Locations

Locations (12)

Akron Mercy Medical Clinic; 🇺🇸 Akron, Iowa, United States

Iowa Specialty Hospitals - Belmond Clinic; 🇺🇸 Belmond, Iowa, United States

Employee Health Clinic, Mercy Cedar Rapids; 🇺🇸 Cedar Rapids, Iowa, United States

Iowa Speciality Hospitals - Clarion Clinic; 🇺🇸 Clarion, Iowa, United States

Great River Medical Group; 🇺🇸 Davenport, Iowa, United States

Des Moines University Family Medicine Clinic; 🇺🇸 Des Moines, Iowa, United States

Grinnell Regional Family Practice; 🇺🇸 Grinnell, Iowa, United States

Knoxville Hospital Clinic; 🇺🇸 Knoxville, Iowa, United States

Newton Clinic, P.C.; 🇺🇸 Newton, Iowa, United States

UI Health Care-River Crossing; 🇺🇸 Riverside, Iowa, United States

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