An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

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).
    

Detailed description: 
      Aim 1: Conduct a randomized, controlled, study of a clinical pharmacist-led disease
      management intervention for patients with a history of non-cardioembolic ischemic stroke
      compared to usual care.

      Hypothesis 1a: More patients in the clinical pharmacy specialist-led disease management group
      will achieve their lipid and blood pressure goals compared to the "Usual Care" group.

      Hypothesis 1b: Fewer patients randomized to the clinical pharmacy specialist-led disease
      management group will have recurrent cardiovascular events or death compared to patients in
      the "usual care" group.

      Hypothesis 1c: More patients with ischemic stroke will receive appropriate secondary
      prevention care using evidence-based medications in the intervention group compared to usual
      care.

      All patients with ICD-9 codes 430.XX to 438.XX will be administratively identified from
      starting January 1, 2000 and administratively pulled into a HealthTrac®-Stroke registry. Each
      patient included in the registry will undergo a validation process to ensure stroke type and
      event dates are accurate. Staff at CPCRS will manually review the electronic medical record
      for each patient in the registry to ensure the ICD-9 code for stroke is accurate according to
      detailed procedures (Appendix I). Patients with history that indicates transient ischemic
      attack, subarachnoid hemorrhage, intracerebral hemorrhage, or cardioembolic stroke will be
      coded as "TIA" or "Hemorrhage" or "Cardioembolic" stroke, respectively, in the registry and
      not eligible for study screening or entry. Patients will be considered to have ischemic
      stroke if there is documentation in the medical record, hospital discharge summary or
      otherwise, indicating the patient had symptoms consistent with a stroke, for example but not
      limited to sudden numbness or weakness of the face, arm or leg, especially on one side of the
      body, sudden confusion, trouble speaking or understanding, sudden trouble seeing in one or
      both eyes, sudden trouble walking, dizziness, loss of balance or coordination, sudden, severe
      headache with no known cause) and/or imaging (MRI or CT scan) of clinically relevant brain
      lesions or there is documentation from a physician noting the patient has had a stroke.12 It
      is estimated that approximately 5200 patients will have validated stroke, of which 4200 will
      have ischemic stroke (both cardioembolic and non-cardioembolic) and approximately 2500 will
      have non-cardioembolic ischemic stroke. All eligible patients with a validated
      non-cardioembolic ischemic stroke diagnosis in the HealthTrac®-Stroke registry will be
      screened for study eligibility by study personnel.

      Intervention (CPCRS) Group: The intervention will utilize clinical pharmacy specialists in
      CPCRS. The intervention will be similar to what is applied to patients with CAD. CPCRS will
      ensure patients have regular laboratory monitoring (i.e. lipids) and blood pressure measures,
      initiated on appropriate lipid-lowering and antihypertensive medications, and receive
      follow-up in a timely manner. 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 intensive dietary counseling will be referred to
      appropriate resources offered at KPCO. Primary care providers will be informed of all
      medication initiations or dosage adjustments. The primary mode of communication between CPCRS
      and patients will be via telephone or e-mail through kp.org.

      Usual Care: Patients randomized to Usual Care will continue to receive
      interventions/procedures they normally receive according to standard/usual care practices.
      Follow-up for Laboratories and Blood Pressure Values: Letters will be mailed to subjects in
      the Intervention group reminding him/her to have appropriate laboratories completed, as
      necessary, using standard CPCRS letters. Patients who fail to have laboratories drawn after 2
      mailed reminder letters separated by 1-month will be marked "noncompliant" in the database
      and receive reminders every 6 months thereafter. For patients in the Usual Care group, no
      reminder letters will be sent. However for assessment of lipid and blood pressure control at
      3 years (primary outcome) for both groups, reminder letters will be mailed, if necessary. All
      patients will be followed for 3 years from randomization or until the first occurrence of
      KPCO termination date, cardiovascular event, or death.
    

Intervention name(s): Intervention (CPCRS) Group; Placebo
Intervention type(s): Other; Other
Intervention description(s): 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.; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention