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

Sponsor

University of Louisiana Monroe (Other)

Overall Status

Completed

CT.gov ID

NCT04098978

Collaborator

Ochsner Health System (Other)

266

Enrollment

Location

Arm

23.6

Actual Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Blood Pressure	Other: Pharmacist Drug Therapy Management	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

266 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Before-after comparison of intervention to traditional careBefore-after comparison of intervention to traditional care

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacist Drug Therapy Management	Other: Pharmacist Drug Therapy Management Patients will be seen by pharmacist for collaborative drug therapy management.

Arm

Intervention/Treatment

Experimental: Pharmacist Drug Therapy Management

Other: Pharmacist Drug Therapy Management

Patients will be seen by pharmacist for collaborative drug therapy management.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Appointment adherence [Through study completion, an average of 1 year.]
Proportion of appointments attended
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
Costs to communities [Through study completion, an average of 1 year.]
Includes healthcare resource utilization, lost productivity
Cost to healthcare systems and payors [Through study completion, an average of 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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