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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01876667
Recruitment Status : Active, not recruiting
First Posted : June 12, 2013
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Stroke Other: Intervention (CPCRS) Group Other: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke
Study Start Date : July 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Active Comparator: Intervention (CPCRS) Group
CPCRS will ensure patients have regular laboratory monitoring and blood pressure measures, appropriate lipid-lowering and antihypertensive medications, and receive follow-up in a timely manner.
Other: Intervention (CPCRS) Group
CPCRS staff will order evidence-based lipid-lowering and/or antihypertensive medications, adjust doses, and order follow-up laboratory parameters, as necessary under pre-approved regional treatment protocols. Patients will be monitored for medication adherence and adverse effects. Patients receive dietary, exercise, and smoking cessation counseling verbally and through mailing of pre-printed Kaiser Permanente approved, patient education pamphlets, as necessary per the discretion of the clinical pharmacy specialist. Patients requiring more dietary counseling will be referred to dieticians, education classes, or other appropriate resources offered at KPCO. Primary care providers will be informed of all medication initiations or dosage adjustments.
Placebo Comparator: Usual Care
Usual Care: Patients randomized to Usual Care will continue to receive interventions/procedures they normally receive according to standard/usual care practices
Other: Placebo
Usual Care

Primary Outcome Measures :
  1. The primary outcome will be the proportion of patients in each group who attain recommended LDL-C and BP goals 3 years after randomization. [ Time Frame: 5 years ]

    The outcome measures selected for the study are based on AHA/ASA guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack.19,20 The surrogate measures to be evaluated are the "ABCs" which include Antiplatelet/antithrombotic therapy, Blood pressure control, Cholesterol control, and Smoking cessation. These variables will be evaluated at various time points during the study in part to evaluate the CPCRS processes of care for attaining surrogate measures in the short-term and maintenance of these outcomes long-term compared to Usual Care. Surrogate outcome measures will be evaluated at 1 and 3 years after randomization.

    The LDL-C goal will be <100 mg/dL for all patients as recommended by clinical practice guidelines.19,20 The proportion of patients with an LDL-C <70 mg/dL in each group will also be reported

Secondary Outcome Measures :
  1. Major cardiovascular events [ Time Frame: 5 years ]
    Cardiovascular events will include fatal or non-fatal stroke, coronary events, or revascularization procedures. Stroke will include either ischemic or hemorrhagic. Coronary events will include acute myocardial infarction ± percutaneous coronary intervention, percutaneous coronary intervention, or coronary artery bypass graft surgery (CABG) surgery. Revascularization procedures include percutaneous coronary intervention, coronary artery bypass graft surgery (CABG) surgery, carotid endarterectomy, interarterial stent insertion. Events will be captured administratively using ICD-9 and/or CPT codes and will be reviewed by individuals blinded the randomization scheme.

  2. Hospitalizations [ Time Frame: over study period ]
    Hospitalizations for any reason will be collected over the study period for all patients.

  3. Death [ Time Frame: over study period ]
    : Death will be captured through KPCO administrative databases. Cause of death will be determined by death certificates and classified as any-cause or cardiovascular. If not cause of death is noted on the death certificate, the cause will be assumed to be cardiovascular. Cardiovascular deaths will include death from cardiac causes, ruptured aortic aneurysm, or peripheral vascular disease. Sudden deaths will be regarded as cardiovascular unless an alternative explanation is documented.

Other Outcome Measures:
  1. Tertiary Outcomes [ Time Frame: over study period ]
    Tertiary outcome measures will describe the effectiveness and safety of the intervention as compared to Usual care.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01876667

United States, Colorado
Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
Aurora, Colorado, United States, 80111
Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: Kari L Olson, PharmD Kaiser Permanente

Responsible Party: Kaiser Permanente Identifier: NCT01876667     History of Changes
Other Study ID Numbers: CPCRS stroke study
10010533 - KPCO IRB ( Other Identifier: KPCO )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases