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

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ClinicalTrials.gov Identifier: NCT01983813
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Korey Kennelty, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Coronary Artery Disease Atrial Fibrillation Stroke Other: PHCVRS Intervention Other: Personal Health Record Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Actual Study Start Date : March 19, 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. [ Time Frame: 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 :
  1. Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c. [ Time Frame: 12 months for each participant ]
    Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01983813


Locations
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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
Korey Kennelty
Investigators
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Principal Investigator: Barry L. Carter, Pharm.D. University of Iowa
Principal Investigator: Barcey T. Levy, M.D., Ph.D. University of Iowa

Publications of Results:
Other Publications:
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Responsible Party: Korey Kennelty, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01983813     History of Changes
Other Study ID Numbers: 201308707
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Individual, de-identified data will be shared with the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BIOLINCC).

Data and supporting materials will include:

  • The analytic data set used in the main outcomes paper
  • Source data sets used to create the analytic data set (for baseline and 12 month follow up data collection points)
  • Informed consent document
  • Study protocol and manuals
  • Subject brochure and subject handout
  • Case report forms (baseline and 12 month follow up)
  • Summary of data redactions
  • Summary of protocol changes over time

All dates will be converted to days or months from a reference event; no text will be included (e.g., comments).

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data and documentation will be provided to BIOLINCC in early 2019 and will be made available to researchers after BIOLINCC staff processes the data and documentation.
Access Criteria:

All reviews for data are coordinated by BioLINCC and are performed by the NHLBI Data Repository Program Officer. The review includes:

  • Appropriateness of the proposed research for the dataset(s) being requested
  • Completion of the IRB requirements to obtain the datasets.

Requests that include datasets must have IRB approval (waiver, expedited review, convened review). Some datasets require that the researcher's IRB provide an expedited (Chairman) or convened review for the proposed project. In these cases, an IRB approval is needed because although obvious identifiers have been redacted, the wealth of individual level data that remain (demographic, anthropometric, medical history, personal history, outcomes) means that the possibility of direct identification of a study subject cannot be eliminated.

Consult the BIOLINCC website (https://biolincc.nhlbi.nih.gov/home/) or access the handbook at https://biolincc.nhlbi.nih.gov/media/guidelines/handbook.pdf for more information.

URL: https://biolincc.nhlbi.nih.gov/home/

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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
High Blood Pressure
High Cholesterol
Heart Irregularity
Stroke
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases