Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
ICARE
1 other identifier
interventional
302
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Mar 2014
Longer than P75 for not_applicable diabetes-mellitus
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedStudy Start
First participant enrolled
March 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 13, 2019
August 1, 2019
2.6 years
October 28, 2013
August 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months for each participant
Secondary Outcomes (1)
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
12 months for each participant
Study Arms (2)
PHCVRS intervention
EXPERIMENTALEach participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Usual care/Personal Health Record
OTHERWill receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Interventions
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.
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korey Kenneltylead
Study Sites (12)
Akron Mercy Medical Clinic
Akron, Iowa, 51001-0200, United States
Iowa Specialty Hospitals - Belmond Clinic
Belmond, Iowa, 50421, United States
Employee Health Clinic, Mercy Cedar Rapids
Cedar Rapids, Iowa, 52403, United States
Iowa Speciality Hospitals - Clarion Clinic
Clarion, Iowa, 50525, United States
Great River Medical Group
Davenport, Iowa, 52897, United States
Des Moines University Family Medicine Clinic
Des Moines, Iowa, 50312, United States
Grinnell Regional Family Practice
Grinnell, Iowa, 50112-1833, United States
Knoxville Hospital Clinic
Knoxville, Iowa, 50138, United States
Newton Clinic, P.C.
Newton, Iowa, 50208-3137, United States
UI Health Care-River Crossing
Riverside, Iowa, 52327, United States
Siouxland Community Health Center
Sioux City, Iowa, 511105, United States
Burlington Area Family Practice Center
West Burlington, Iowa, 52655-1645, United States
Related Publications (8)
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.
PMID: 25952471BACKGROUNDYang 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.
PMID: 28693427BACKGROUNDKennelty 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.
PMID: 29349522BACKGROUNDCarter 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.
PMID: 26032927BACKGROUNDCarter 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.
PMID: 27993832BACKGROUNDPatel 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.
PMID: 31119096BACKGROUNDCarter 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.
PMID: 29237101BACKGROUNDCarter 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.
PMID: 29884657RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry L. Carter, Pharm.D.
University of Iowa
- PRINCIPAL INVESTIGATOR
Barcey T. Levy, M.D., Ph.D.
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 14, 2013
Study Start
March 19, 2014
Primary Completion
November 1, 2016
Study Completion
April 1, 2018
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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).