An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/8/2018 |
| Start Date: | July 2010 |
| End Date: | November 14, 2018 |
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).
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).
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.
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.
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"
We found this trial at
1
site
Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
Aurora, Colorado 80011
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