Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01983813
First received: October 28, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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. The study will be conducted in 12 medical practices in Iowa that are either a Federally Qualified Health Center or part of the IRENE practice-based research network.


Condition Intervention
Diabetes Mellitus
Hypertension
Coronary Artery Disease
Atrial Fibrillation
Stroke
Other: PHCVRS Intervention
Other: Personal Health Record

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. [ Time Frame: 12 months for each participant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c. [ Time Frame: 12 months for each participant ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Other: PHCVRS Intervention

A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:

  1. Contact via email, phone or text every 2-4 weeks
  2. Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease.
  3. Collaborative communication with the participant's physician to address gaps in screening or therapy, update medication list, and recommend medication changes.

Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk.

Other: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Usual care/Personal Health Record
Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Other: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have at least one of the following conditions

    • Uncontrolled diabetes (Hemoglobin A1c > or + 7.5
    • Elevated LDL cholesterol > 110 for patients with stroke or diabetes or > 140 otherwise
    • Elevated blood pressure with systolic pressure 140 or higher in persons who have diabetes or chronic kidney disease and 150 or higher otherwise.
  • Persons who have only one or two of the conditions listed above must also have had one or more of the following conditions, so that the total number of conditions is at least three:

    • Coronary Artery Disease
    • Previous Heart Attack
    • Stroke or Transient Ischemic Attack
    • Atrial fibrillation
    • Peripheral Vascular Disease
    • Smoker
    • Obesity

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983813

Locations
United States, Iowa
Akron Mercy Medical Clinic
Akron, Iowa, United States, 51001-0200
Employee Health Clinic, Mercy Cedar Rapids
Cedar Rapids, Iowa, United States, 52403
Great River Medical Group
Davenport, Iowa, United States, 52897
Grinnell Regional Family Practice
Grinnell, Iowa, United States, 50112-1833
Newton Clinic, P.C.
Newton, Iowa, United States, 50208-3137
UI Health Care-River Crossing
Riverside, Iowa, United States, 52327
Siouxland Community Health Center
Sioux City, Iowa, United States, 511105
Burlington Area Family Practice Center
West Burlington, Iowa, United States, 52655-1645
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Barry L. Carter, Pharm.D. University of Iowa
Principal Investigator: Barcey T. Levy, M.D., Ph.D. University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01983813     History of Changes
Other Study ID Numbers: 1 R01 HL116311-01A1
Study First Received: October 28, 2013
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Diabetes
High Blood Pressure
High Cholesterol
Heart Irregularity
Stroke

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Hypertension
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014