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Completed

NCT Number: NCT04098978

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

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.

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Vascular Diseases

Age range

4 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Health Center for Children

West Monroe, Louisiana, 71292, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist Drug Therapy Management

Other

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

Primary outcomes

  1. Proportion of patients with adequately-controlled hypertension at 3 months.

    Time frame: 3 months

  2. Proportion of patients with adequately-controlled hypertension at 6 months.

    Time frame: 6 months

  3. Proportion of patients with adequately-controlled hypertension at 12 months.

    Time frame: 12 months

  4. Time to adequate control of hypertension.

    Time frame: Through study completion, an average of 1 year.

    Defined as the first appointment with controlled hypertension.

Secondary outcomes

  1. Appointment adherence

    Time frame: Through study completion, an average of 1 year.

    Proportion of appointments attended

  2. 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.

  3. 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.

  4. Costs to patients

    Time frame: Through study completion, an average of 1 year.

    Includes direct medical, direct nonmedical, indirect costs

  5. Costs to communities

    Time frame: Through study completion, an average of 1 year.

    Includes healthcare resource utilization, lost productivity

  6. Cost to healthcare systems and payors

    Time frame: Through study completion, an average of 1 year.

Sponsors and collaborators

Lead sponsor

University of Louisiana Monroe

Other

Collaborators

  • Ochsner Health System

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2019
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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