Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
NCT ID: NCT01983813
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2014-03-19
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
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.
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.
Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Interventions
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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.
Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Eligibility Criteria
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Inclusion 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
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
50 Years
ALL
No
Sponsors
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Korey Kennelty
OTHER
Responsible Party
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Korey Kennelty
Assistant Professor
Principal Investigators
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Barry L. Carter, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Barcey T. Levy, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Akron Mercy Medical Clinic
Akron, Iowa, United States
Iowa Specialty Hospitals - Belmond Clinic
Belmond, Iowa, United States
Employee Health Clinic, Mercy Cedar Rapids
Cedar Rapids, Iowa, United States
Iowa Speciality Hospitals - Clarion Clinic
Clarion, Iowa, United States
Great River Medical Group
Davenport, Iowa, United States
Des Moines University Family Medicine Clinic
Des Moines, Iowa, United States
Grinnell Regional Family Practice
Grinnell, Iowa, United States
Knoxville Hospital Clinic
Knoxville, Iowa, United States
Newton Clinic, P.C.
Newton, Iowa, United States
UI Health Care-River Crossing
Riverside, Iowa, United States
Siouxland Community Health Center
Sioux City, Iowa, United States
Burlington Area Family Practice Center
West Burlington, Iowa, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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201308707
Identifier Type: -
Identifier Source: org_study_id
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