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: June 2, 2015
Last verified: June 2015
  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

Section A: Demographic Criteria

  1. Patient was seen in your clinic or practice at least once in the past 24 months
  2. English-speaking male or female
  3. Age is 50 or older at medical record screening

    Section B: Risk Factors - Must have at least one of the following conditions

  4. Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
  5. Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise
  6. Elevated blood pressure with:

    • Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic kidney disease OR
    • Systolic BP >= 150 in persons with uncomplicated hypertension

    Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE

  7. History of coronary artery disease
  8. Previous Heart Attack
  9. History of Stroke
  10. History of Transient Ischemic Attack
  11. History of Atrial fibrillation
  12. History of Peripheral Vascular Disease / claudication
  13. History of carotid artery disease
  14. Current smoker
  15. Obesity with BMI > 30

    EXCLUSION CRITERIA

    Section D: Exclusion Criteria - has NONE of the following:

  16. Inability to give informed consent
  17. Pregnant
  18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
  19. Cancer diagnosis with a life expectancy estimated less than 2 years
  20. Residence in a nursing home or diagnosis of dementia
  21. No telephone or a hearing impairment not allowing them to use a phone
  22. Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
  23. Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
  24. Omron blood pressure cuff cannot be used on patient's arm for any reason
  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
Iowa Specialty Hospitals - Belmond Clinic
Belmond, Iowa, United States, 50421
Employee Health Clinic, Mercy Cedar Rapids
Cedar Rapids, Iowa, United States, 52403
Iowa Speciality Hospitals - Clarion Clinic
Clarion, Iowa, United States, 50525
Great River Medical Group
Davenport, Iowa, United States, 52897
Des Moines University Family Medicine Clinic
Des Moines, Iowa, United States, 50312
Grinnell Regional Family Practice
Grinnell, Iowa, United States, 50112-1833
Knoxville Hospital Clinic
Knoxville, Iowa, United States, 50138
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

Publications:
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: June 2, 2015
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
Coronary Disease
Myocardial Ischemia
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on July 30, 2015