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.

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.

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

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).

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.

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.