An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke
|ClinicalTrials.gov Identifier: NCT01876667|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2013
Last Update Posted : October 4, 2016
|First Submitted Date ICMJE||August 28, 2012|
|First Posted Date ICMJE||June 12, 2013|
|Last Update Posted Date||October 4, 2016|
|Study Start Date ICMJE||July 2010|
|Estimated Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01876667 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE
||Tertiary Outcomes [ Time Frame: over study period ]
Tertiary outcome measures will describe the effectiveness and safety of the intervention as compared to Usual care.
|Original Other Outcome Measures ICMJE||Same as current|
|Brief Title ICMJE||An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke|
|Official Title ICMJE||An Evaluation of Clinical Pharmacist-led Intervention on Clinical Outcomes in Patients With Ischemic Stroke|
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).
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||June 2017|
|Estimated Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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.
Patients will be excluded if:
|Ages||18 Years to 85 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01876667|
|Other Study ID Numbers ICMJE||CPCRS stroke study
10010533 - KPCO IRB ( Other Identifier: KPCO )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Kaiser Permanente|
|Study Sponsor ICMJE||Kaiser Permanente|
|Collaborators ICMJE||Not Provided|
|PRS Account||Kaiser Permanente|
|Verification Date||October 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP