Clinical trial NCT01983813: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Official title: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Coronary Artery Disease
Atrial Fibrillation
Stroke
Keywords: Diabetes
High Blood Pressure
High Cholesterol
Heart Irregularity
Stroke
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 302
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
timeFrame: 12 months for each participant
Secondary outcomes:
measure: Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
timeFrame: 12 months for each participant
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Mercy Medical Clinic
state: Iowa
city: Belmond
country: United States
facility: Iowa Specialty Hospitals - Belmond Clinic
state: Iowa
city: Cedar Rapids
country: United States
facility: Employee Health Clinic, Mercy Cedar Rapids
state: Iowa
city: Clarion
country: United States
facility: Iowa Speciality Hospitals - Clarion Clinic
state: Iowa
city: Davenport
country: United States
facility: Great River Medical Group
state: Iowa
city: Des Moines
country: United States
facility: Des Moines University Family Medicine Clinic
state: Iowa
city: Grinnell
country: United States
facility: Grinnell Regional Family Practice
state: Iowa
city: Knoxville
country: United States
facility: Knoxville Hospital Clinic
state: Iowa
city: Newton
country: United States
facility: Newton Clinic, P.C.
state: Iowa
city: Riverside
country: United States
facility: UI Health Care-River Crossing
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Community Health Center
state: Iowa
city: West Burlington
country: United States
facility: Burlington Area Family Practice Center
state: Iowa
Study officials:
affiliation: University of Iowa
name: Barry L. Carter, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Barcey T. Levy, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.