Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE)
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March 2014-November 2016
March 17, 2020
Clinical Trial URLs
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
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
More than 2200 Americans die of cardiovascular disease every day. Team-based care and medication therapy management have become useful strategies to reduce gaps in delivery of guideline-concordant therapy for cardiovascular therapy. Physician offices, especially in rural and smaller communities, lack the resources to implement team-based care with pharmacists who can provide medication therapy management. The ICARE trial developed a physician-pharmacist collaborative model to provide virtual clinical pharmacy services from a central location to 12 family medicine offices in Iowa to evaluate whether a centralized, remote, clinical pharmacy service could improve outcomes.
Subject inclusion had 3 separate processes. First, subjects were required to be an English-speaking male or female over the age of 50 that had been seen in the clinic/practice at least once in the past 24 months. Second, subjects were required to have at least one of the following conditions: uncontrolled diabetes (hemoglobin A1c > 7.5%); low density lipoprotein cholesterol (LDL-c) > 110 mg/dl for patients with a history of peripheral artery disease, coronary artery disease, stroke, transient ischemic attack, or diabetes, elevated blood pressure with systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg in persons with diabetes or chronic kidney disease OR systolic BP ≥ 150 mmHg or diastolic BP ≥ 90 mm Hg in persons with uncomplicated hypertension. Third, subjects were required to additionally have 3 or more of the following cardiovascular conditions or risk factors: history of myocardial infarction, coronary artery disease, stroke, transient ischemic attack, atrial fibrillation, peripheral vascular disease/claudication; current smoker; obesity with BMI > 30.
Exclusion criteria included diagnosis of primary pulmonary hypertension, a 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, or patient had plans to move from the area or transfer care to a different clinic in the next 12 months.
In total, there were 302 subjects enrolled in the ICARE trial. Of these, 259 subjects completed the 12-month visit.
The study included 11 private physician offices and 1 Federally Qualified Health Center. Offices were identified from the Iowa Research Network, and screened for their ability to conduct the trial, enroll subjects, and meet quality control measures. A Study Coordinator employed in each office identified, screened, and recruited subjects. All subjects and physician in a given office received either the intervention or usual care.
Blood pressure, Hemoglobin A1c, and LDL cholesterol were collected at baseline and 12 months regardless of whether the subject had a diagnosis of hypertension, diabetes, or hyperlipidemia. Baseline data were collected on case report forms by Study Coordinators and entered centrally by the research team.
Three clinical pharmacy specialists located within the research offices of the principal investigator provided the intervention. Pharmacists were required to have a Doctor of Pharmacy degree and a minimum of one year of clinical residency (or equivalent practice experience). The pharmacists travelled to each intervention office to be introduced to the providers and facilitate team-building before the intervention started. These sessions explored the providers’ preferred methods and frequency of communication with the pharmacists based on other telemedicine studies. Pharmacists had access to the baseline data, including BP and laboratory values, which was used to reconcile medications and update the medical records. Pharmacists monitored blood glucose values, BP readings, laboratory values, and potential adverse events from the EMR or the patient in order to recommend medication changes to the medical provider. Interventions for physicians were directed at improving guideline adherence for reducing CV risk and preventive care based on the Guideline Advantage (GA) criteria.
Each subject was assigned to one of the three pharmacists to maintain continuity. Subjects were assigned to the pharmacists in the order they were enrolled into the study, independent of medical office. Subjects were primarily contacted by telephone and counseled by the pharmacists about beneficial health behavior changes related to tobacco use, diet, physical activity, and alcohol consumption. Medications and dosages were reconciled. The pharmacists identified problems related to poor disease control, subject misunderstandings, poor medication adherence or failure to receive preventive health services, adverse effects, drug interactions or cost. Pharmacists provided patient education when problems were identified and developed a plan for follow-up contacts, generally every 1–2 weeks by telephone if there were continuing problems or medication issues. The primary outcome measure was adherence to the GA criteria.
There was no improvement in the GA score from baseline to 12 months in the control group. There was a statistically significant improvement in the intervention group in GA score plus several criteria were significantly better for intervention subjects including appropriate statin therapy, body mass index (BMI) screening and alcohol screening. Only 13.7% of subjects with diabetes had hemoglobin A1C at goal at baseline and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months.
The improvements in outcomes were modest, and not statistically significant, due to higher than anticipated baseline guideline adherence and more inter-office variability than anticipated.
Carter, B. L., Levy, B., Gryzlak, B., Xu, Y., Chrischilles, E., Dawson, J., Vander Weg, M., Christensen, A., James, P., & Polgreen, L. (2018). Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices. Circulation. Cardiovascular quality and outcomes, 11(6), e004188. https://doi.org/10.1161/CIRCOUTCOMES.117.004188
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 404.0 KB)
- ICARE 12 Month Followup Forms (PDF - 2.1 MB)
- ICARE Baseline Forms (PDF - 1.3 MB)
- ICARE Control Sites MOP (PDF - 5.2 MB)
- ICARE Intervention Sites MOP (PDF - 5.6 MB)
- ICARE Protocol (PDF - 6.8 MB)
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