An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

Clinical pharmacy specialists are in an ideal position to assist medical teams in the management of patients with ischemic stroke. Given their extensive and specialized knowledge regarding medication efficacy, safety, and cost-effective use as well as their ability to critically review, interpret and apply the results from clinical studies to patient care, clinical pharmacy specialists have the potential to have a significant impact on stroke care delivery. There are numerous opportunities for clinical pharmacy specialists to become more extensively involved in the delivery of care to these high-risk patients. However, to-date there are few studies demonstrating the impact of clinical pharmacy specialists on outcomes of patients with stroke Stroke is the third leading cause of death in the United States (U.S.) and the most common life-threatening neurologic disorder.1 Stroke is a leading cause of long-term disability and results in significant individual and societal financial burdens. In 2006, stroke accounted for 1 of every 18 deaths and ischemic stroke accounted for 87% of all strokes.1 In the U.S., out of the approximately 795,000 people who develop a stroke each year, approximately 185,000 (23%) are recurrent events.1 After the first year, the average annual risk for recurrent stroke is 4%.2 Patients who survive at least 30 days after a first-ever stroke, have an average annual risk of death of 9.1%, much of the risk due to nonstroke cardiovascular disease. Despite the evidence supporting the use of various therapeutic interventions within the ischemic stroke population, a significant proportion of patients continue to have uncontrolled risk factors and remain undertreated.26-30 A recent prospective study of more than 4933 high-risk patients reported that, as compared to patients with coronary artery disease, patients with cerebrovascular disease are undertreated and thus less likely to achieve blood pressure (45.3% vs. 57.3%; p\<0.001) and lipid (19.4% vs. 30.5%; p\<0.001) targets.28 Although the reasons for the so-called "treatment gap" have not been explored specifically within this population, data from studies within the coronary artery disease population suggest that provider, patient and health care system factors likely all contribute. This will be the first, prospective, randomized study to evaluate the impact of a clinical pharmacist disease management program on both surrogate and clinical outcomes for patients with non-cardioembolic ischemic stroke. This will be a randomized, controlled study comparing a clinical pharmacist-led disease management intervention by the Clinical Pharmacy Cardiac Risk Service (CPCRS) to usual care (UC).

Key facts

Study ID

NCT01876667

Run by

Kaiser Permanente

People needed

141

Starts

2010-07-01

Expected to finish

2018-11-14

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• All active KPCO non-institutionalized patients from the Denver/Boulder metropolitan area with a validated non-cardioembolic ischemic stroke diagnosis within the past 5 years who:
• Are ≥18 years of age at the time of informed consent, and Are Eligible for CPCRS enrollment, and Have uncontrolled blood pressure (the most recent value >130/80 mmHg noted in the medical record), and/or Have last LDL-C, within the previous 365 days, that is ≥100 mg/dL.

You may not qualify if…

• Patients will be excluded if:
• 85 years of age at the time of consent, Have transient ischemic attacks, subarachnoid hemorrhage,intracerebral hemorrhage, or cardioembolic stroke as their only validated stroke history, Die within 30 days of stroke, Are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS). These patients either have a history of coronary artery disease (acute MI, CABG, percutaneous coronary interventions, and/or coronary catheterizations), are at high-risk for CAD as determined by the cardiologist, or have peripheral arterial disease, Have a diagnosis of dementia or a terminal illness in which the life expectancy is <3 years per the discretion of the primary care provider, Have notation in the medical record of memory issues or other conditions which, based on the judgment of study staff, suggest that the patient may not be able to provide informed consent, Are pregnant or breast-feeding, or Do not consent to participate Currently listed on the "Do Not Call List"

Where it is running

• Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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