Blood Pressure, Hypertension
Conditions
Keywords
Children, Adolescents, Young Adults, Pediatric Hypertension, Pharmacoeconomics, Pharmacist
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.
Interventions
OTHERPharmacist Drug Therapy Management
Patients will be seen by pharmacist for collaborative drug therapy management.
Sponsors
Ochsner Health System
University of Louisiana Monroe
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Before-after comparison of intervention to traditional care
Eligibility
Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through study completion, an average of 1 year. | Defined as the first appointment with controlled hypertension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs to communities | Through study completion, an average of 1 year. | Includes healthcare resource utilization, lost productivity |
| Appointment adherence | Through study completion, an average of 1 year. | Proportion of appointments attended |
| Cost to healthcare systems and payors | Through study completion, an average of 1 year. | — |
| Number and type of serious adverse drug events | Through study completion, an average of 1 year. | Number of serious adverse drug events in aggregate and subgrouped. |
| Number of unplanned health care encounters related to hypertension | Through study completion, an average of 1 year. | Surrogate for adverse event associated with treatment or disease state. |
| Costs to patients | Through study completion, an average of 1 year. | Includes direct medical, direct nonmedical, indirect costs |
Countries
United States
Outcome results
None listed