Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Stroke Clinical Trial

— ICARE  

Official title:

Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983813
• Other study ID #: 201308707
• Status: Completed
• Phase: N/A
• Start date: March 19, 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: April 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Hypertension
• Myocardial Ischemia
• Stroke

Intervention

Other:
• PHCVRS Intervention
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.
• Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Korey Kennelty

Country where clinical trial is conducted

United States, 

References & Publications (8)

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). pii: e004432. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months for each participant