Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 302
- Locations
- 12
- Primary Endpoint
- Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •History of Atrial fibrillation
- •History of Peripheral Vascular Disease / claudication
- •History of carotid artery disease
- •Current smoker
- •Obesity with BMI > 30
Exclusion Criteria
- •Section D: Exclusion Criteria - has NONE of the following:
- •Inability to give informed consent
- •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
Arms & Interventions
PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Intervention: PHCVRS Intervention (Other)
PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Intervention: Personal Health Record (Other)
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.
Intervention: Personal Health Record (Other)
Outcomes
Primary Outcomes
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Time Frame: 12 months for each participant
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.
Secondary Outcomes
- Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.(12 months for each participant)
Investigators
Korey Kennelty
Assistant Professor
University of Iowa