Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension

Study Overview
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Brief Summary
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This study will measure the effect of a novel pharmacy practice model on pediatric patients with hypertension. In North Louisiana, many patients have to travel to see subspecialists for treatment for hypertension and elevated blood pressure, which has many costs including direct medical costs, direct nonmedical costs, and indirect costs like missed time from work, school, or social obligations. Also, many patients who have to travel to get to their appointments have a high rate of missed appointments, which can be bad for overall health. This study will use a pharmacist to perform collaborative drug therapy management with pediatric cardiologists to manage therapy for patients with hypertension or elevated blood pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by telecommunications. Pharmacist drug therapy management and telemedicine have been studied separately, but this is the first study with pharmacist drug therapy management by telemedicine for pediatric patients. If this model is successful, it could be replicated in other rural areas to improve patient care and reduce healthcare costs.

Official Title
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Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension

Conditions
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Hypertension, Blood Pressure

Intervention / Treatment
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* Other: Pharmacist Drug Therapy Management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of elevated blood pressure or hypertension. Physician decision to treat with drug therapy or lifestyle modifications and physician referral to pharmacist. Consent both to therapy with pharmacist and participation in study (Note: in the state of Louisiana, patients must provide consent to be treated in a collaborative drug therapy management program). For patients younger than 18, informed assent and parental permission to participate in the study. For patients who turn 18 during the study, informed consent will be obtained on the first visit after they turn 18. Males and females; age 4-20 at enrollment Willingness to adhere to study regimen The same inclusion criteria will apply to control patients except that: They will have been treated at the clinic for hypertension or elevated blood pressure during the control period. A waiver of consent has been obtained for historical data. Exclusion Criteria: Physical preclusion to taking blood pressure, such as lack of limbs or any congenital or acquired anatomical defect preventing routine measurement of blood pressure Participation in another treatment or intervention study for hypertension during the study period Inability to speak English For patients under 18 years old, not having at least one parent or guardian able to speak English Patients who are pregnant

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Before-after comparison of intervention to traditional care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Drug Therapy Management<br> | Other: Pharmacist Drug Therapy Management<br>* Patients will be seen by pharmacist for collaborative drug therapy management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adequately-controlled hypertension at 3 months. |  | 3 months | 
| Proportion of patients with adequately-controlled hypertension at 6 months. |  | 6 months | 
| Proportion of patients with adequately-controlled hypertension at 12 months. |  | 12 months | 
| Time to adequate control of hypertension. | Defined as the first appointment with controlled hypertension. | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appointment adherence | Proportion of appointments attended | Through study completion, an average of 1 year. | 
| Number and type of serious adverse drug events | Number of serious adverse drug events in aggregate and subgrouped. | Through study completion, an average of 1 year. | 
| Number of unplanned health care encounters related to hypertension | Surrogate for adverse event associated with treatment or disease state. | Through study completion, an average of 1 year. | 
| Costs to patients | Includes direct medical, direct nonmedical, indirect costs | Through study completion, an average of 1 year. | 
| Costs to communities | Includes healthcare resource utilization, lost productivity | Through study completion, an average of 1 year. | 
| Cost to healthcare systems and payors |  | Through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Adolescents, Young Adults, Pediatric Hypertension, Pharmacoeconomics, Pharmacist