Clinical trial NCT04098978: Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
Official title: Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Keywords: Children
Adolescents
Young Adults
Pediatric Hypertension
Pharmacoeconomics
Pharmacist
Lead sponsor: University of Louisiana Monroe
Sponsor class: OTHER
Collaborators: name: Ochsner Health System
First posted: 2019-09-23
Enrollment: 266
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Before-after comparison of intervention to traditional care
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with adequately-controlled hypertension at 3 months.
timeFrame: 3 months
measure: Proportion of patients with adequately-controlled hypertension at 6 months.
timeFrame: 6 months
measure: Proportion of patients with adequately-controlled hypertension at 12 months.
timeFrame: 12 months
measure: Time to adequate control of hypertension.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Appointment adherence
timeFrame: Through study completion, an average of 1 year.
measure: Number and type of serious adverse drug events
timeFrame: Through study completion, an average of 1 year.
measure: Number of unplanned health care encounters related to hypertension
timeFrame: Through study completion, an average of 1 year.
measure: Costs to patients
timeFrame: Through study completion, an average of 1 year.
measure: Costs to communities
timeFrame: Through study completion, an average of 1 year.
measure: Cost to healthcare systems and payors
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: West Monroe
country: United States
facility: Ochsner Health Center for Children
state: Louisiana
Study officials:
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