Ischemic Stroke Clinical Trial
Official title:
Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high
risk of having another stroke or a heart attack. Conditions like high blood pressure and high
cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the
risk of stroke and heart disease. Aggressive treatment of these risk factors however, can
significantly reduce the chance of another stroke, heart attack or death.
This study will look at different ways to optimize blood pressure and cholesterol levels and
educate people about positive lifestyle changes.
BACKGROUND: Epidemiological studies have shown that a number of conditions increase the risk
of stroke and other vascular diseases and there is compelling evidence from large randomized
trials that treatment of these risk factors, especially hypertension and high cholesterol,
can significantly lower future cardiovascular risk. Survivors of TIA or stroke are at high
risk for recurrent stroke, MI, or death (22% at one year) and aggressive treatment of
vascular risk factors can reduce the risk of recurrence by over 25%. However, vascular risk
factors, especially hypertension and high cholesterol, are not managed optimally in patients
after a TIA or stroke, even in those patients seen in specialized Stroke Prevention Clinics
(SPCs). This gap between the evidence for secondary prevention of stroke and the clinical
reality leads to sub-optimal patient outcomes. There is limited data on interventions proven
to improve outcomes in patients with stroke or TIA.
To improve the quality of care for any condition or patient population, one needs to address
structure, process, and outcomes. In this study, we will be creating and testing a new
structure for delivery of stroke prevention services - we anticipate this new structure will
improve processes of care which in turn should lead to improved outcomes.
Hypothesis:
Compared with usual care, we hypothesize that a pharmacist case manager intervention will
improve blood pressure and serum lipid levels (by employing standardized treatment protocols
to guideline-recommended targets), the management of other risk factors,enhance medication
adherence, and increase health-related quality of life.
Design:
A prospective, randomized, controlled open-label with blinded ascertainment of outcomes
(PROBE) trial. Patients with a recent stroke or TIA evaluated in any of the 3 stroke
prevention clinics (SPC) in Edmonton, Canada,will be randomized to usual care or the
"pharmacist case manager intervention".
Usual care patients will will receive the same educational materials about stroke risk
factors and medication adherence as the "intervention" patients, will be seen monthly by a
study nurse, will have the same number of BP measurements as "intervention" patients, and
will have a fax sent to their family physician after each study visit reporting their BP.
Over and above usual care, the intervention group will include intensive pharmacist
case-management over 6 months consisting of the following:
- monthly follow-up visits with focus on vascular protection; these clinic visits will be
run parallel to, but independent of, any follow-up at the SPC and will include provision
to each patient of their individual cardiovascular disease risk profile using the the CV
Health Manager software.
- Initiation, monitoring and titration of medications related to blood pressure and
dyslipidemia, using Canadian national guideline-recommended treatment targets.
- Medication adherence management on an ongoing basis, including access to Dosettes®,
blister packs, and reminder tools as deemed necessary.
- Independent capacity to refer to allied health services (including dieticians and weight
loss services, diabetes education centres, and smoking cessation counselors).
- Regular feedback to the primary care physician and the stroke specialist of record,
regarding all stroke prevention related activities.
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