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

June 2, 2022 updated by: University of Louisiana Monroe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • West Monroe, Louisiana, United States, 71292
        • Ochsner Health Center for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with adequately-controlled hypertension at 3 months.
Time Frame: 3 months
3 months
Proportion of patients with adequately-controlled hypertension at 6 months.
Time Frame: 6 months
6 months
Proportion of patients with adequately-controlled hypertension at 12 months.
Time Frame: 12 months
12 months
Time to adequate control of hypertension.
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
Proportion of appointments attended
Through study completion, an average of 1 year.
Number and type of serious adverse drug events
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
Surrogate for adverse event associated with treatment or disease state.
Through study completion, an average of 1 year.
Costs to patients
Time Frame: Through study completion, an average of 1 year.
Includes direct medical, direct nonmedical, indirect costs
Through study completion, an average of 1 year.
Costs to communities
Time Frame: Through study completion, an average of 1 year.
Includes healthcare resource utilization, lost productivity
Through study completion, an average of 1 year.
Cost to healthcare systems and payors
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisiana Monroe

Collaborators

Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 14, 2020

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (ACTUAL)

September 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be available to researchers within the University of Louisiana Monroe based on IRB review and approval.

IPD Sharing Time Frame

Upon completion of study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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