Back to resultsImproved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE)
Primary Purpose
Diabetes Mellitus, Hypertension, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PHCVRS Intervention
Personal Health Record
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, High Blood Pressure, High Cholesterol, Heart Irregularity, Stroke
Eligibility Criteria
INCLUSION CRITERIA
Section A: Demographic Criteria
- Patient was seen in your clinic or practice at least once in the past 24 months
- English-speaking male or female
Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
- Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
- Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise
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
- History of coronary artery disease
- Previous Heart Attack
- History of Stroke
- History of Transient Ischemic Attack
- History of Atrial fibrillation
- History of Peripheral Vascular Disease / claudication
- History of carotid artery disease
- Current smoker
Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
- Inability to give informed consent
- Pregnant
- Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
- Cancer diagnosis with a life expectancy estimated less than 2 years
- Residence in a nursing home or diagnosis of dementia
- No telephone or a hearing impairment not allowing them to use a phone
- Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
- Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
- Omron blood pressure cuff cannot be used on patient's arm for any reason
Sites / Locations
- Akron Mercy Medical Clinic
- Iowa Specialty Hospitals - Belmond Clinic
- Employee Health Clinic, Mercy Cedar Rapids
- Iowa Speciality Hospitals - Clarion Clinic
- Great River Medical Group
- Des Moines University Family Medicine Clinic
- Grinnell Regional Family Practice
- Knoxville Hospital Clinic
- Newton Clinic, P.C.
- UI Health Care-River Crossing
- Siouxland Community Health Center
- Burlington Area Family Practice Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PHCVRS intervention
Usual care/Personal Health Record
Arm Description
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Outcomes
Primary Outcome Measures
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
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
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01983813
Brief Title
Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Acronym
ICARE
Official Title
Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Korey Kennelty
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension, Coronary Artery Disease, Atrial Fibrillation, Stroke
Keywords
Diabetes, High Blood Pressure, High Cholesterol, Heart Irregularity, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PHCVRS intervention
Arm Type
Experimental
Arm Description
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Arm Title
Usual care/Personal Health Record
Arm Type
Other
Arm Description
Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Intervention Type
Other
Intervention Name(s)
PHCVRS Intervention
Intervention Description
A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:
Contact via email, phone or text every 2-4 weeks
Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease.
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.
Intervention Type
Other
Intervention Name(s)
Personal Health Record
Intervention Description
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Primary Outcome Measure Information:
Title
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Description
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.
Time Frame
12 months for each participant
Secondary Outcome Measure Information:
Title
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Description
Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.
Time Frame
12 months for each participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
Section A: Demographic Criteria
Patient was seen in your clinic or practice at least once in the past 24 months
English-speaking male or female
Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise
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
History of coronary artery disease
Previous Heart Attack
History of Stroke
History of Transient Ischemic Attack
History of Atrial fibrillation
History of Peripheral Vascular Disease / claudication
History of carotid artery disease
Current smoker
Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
Inability to give informed consent
Pregnant
Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
Cancer diagnosis with a life expectancy estimated less than 2 years
Residence in a nursing home or diagnosis of dementia
No telephone or a hearing impairment not allowing them to use a phone
Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
Omron blood pressure cuff cannot be used on patient's arm for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry L. Carter, Pharm.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barcey T. Levy, M.D., Ph.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Mercy Medical Clinic
City
Akron
State/Province
Iowa
ZIP/Postal Code
51001-0200
Country
United States
Facility Name
Iowa Specialty Hospitals - Belmond Clinic
City
Belmond
State/Province
Iowa
ZIP/Postal Code
50421
Country
United States
Facility Name
Employee Health Clinic, Mercy Cedar Rapids
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Iowa Speciality Hospitals - Clarion Clinic
City
Clarion
State/Province
Iowa
ZIP/Postal Code
50525
Country
United States
Facility Name
Great River Medical Group
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52897
Country
United States
Facility Name
Des Moines University Family Medicine Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50312
Country
United States
Facility Name
Grinnell Regional Family Practice
City
Grinnell
State/Province
Iowa
ZIP/Postal Code
50112-1833
Country
United States
Facility Name
Knoxville Hospital Clinic
City
Knoxville
State/Province
Iowa
ZIP/Postal Code
50138
Country
United States
Facility Name
Newton Clinic, P.C.
City
Newton
State/Province
Iowa
ZIP/Postal Code
50208-3137
Country
United States
Facility Name
UI Health Care-River Crossing
City
Riverside
State/Province
Iowa
ZIP/Postal Code
52327
Country
United States
Facility Name
Siouxland Community Health Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
511105
Country
United States
Facility Name
Burlington Area Family Practice Center
City
West Burlington
State/Province
Iowa
ZIP/Postal Code
52655-1645
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/
Citations:
PubMed Identifier
25952471
Citation
Carter BL, Levy BT, Gryzlak B, Chrischilles EA, Vander Weg MW, Christensen AJ, James PA, Moss CA, Parker CP, Gums T, Finkelstein RJ, Xu Y, Dawson JD, Polgreen LA. A centralized cardiovascular risk service to improve guideline adherence in private primary care offices. Contemp Clin Trials. 2015 Jul;43:25-32. doi: 10.1016/j.cct.2015.04.014. Epub 2015 May 4.
Results Reference
background
PubMed Identifier
28693427
Citation
Yang R, Carter BL, Gums TH, Gryzlak BM, Xu Y, Levy BT. Selection bias and subject refusal in a cluster-randomized controlled trial. BMC Med Res Methodol. 2017 Jul 10;17(1):94. doi: 10.1186/s12874-017-0368-7.
Results Reference
background
PubMed Identifier
29349522
Citation
Kennelty KA, Polgreen LA, Carter BL. Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature. Curr Hypertens Rep. 2018 Jan 18;20(1):1. doi: 10.1007/s11906-018-0803-0.
Results Reference
background
PubMed Identifier
26032927
Citation
Carter BL. Will Team-Based Care Really be Implemented? J Clin Hypertens (Greenwich). 2015 Sep;17(9):692-3. doi: 10.1111/jch.12578. Epub 2015 Jun 1. No abstract available.
Results Reference
background
PubMed Identifier
27993832
Citation
Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.
Results Reference
background
PubMed Identifier
31119096
Citation
Patel E, Pevnick JM, Kennelty KA. Pharmacists and medication reconciliation: a review of recent literature. Integr Pharm Res Pract. 2019 Apr 30;8:39-45. doi: 10.2147/IPRP.S169727. eCollection 2019.
Results Reference
background
PubMed Identifier
29237101
Citation
Carter BL. Collaborative care model for hypertension. J Clin Hypertens (Greenwich). 2018 Jan;20(1):96-97. doi: 10.1111/jch.13142. Epub 2017 Dec 13. No abstract available.
Results Reference
background
PubMed Identifier
29884657
Citation
Carter BL, Levy B, Gryzlak B, Xu Y, Chrischilles E, Dawson J, Vander Weg M, Christensen A, James P, Polgreen L. Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004188. doi: 10.1161/CIRCOUTCOMES.117.004188.
Results Reference
result
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Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
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