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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098978
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Ochsner Health System
Information provided by (Responsible Party):
University of Louisiana Monroe

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Before-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 : January 14, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098978


Locations
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United States, Louisiana
Ochsner Health Center for Children
West Monroe, Louisiana, United States, 71292
Sponsors and Collaborators
University of Louisiana Monroe
Ochsner Health System
Publications:

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Responsible Party: University of Louisiana Monroe
ClinicalTrials.gov Identifier: NCT04098978    
Other Study ID Numbers: 1
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be available to researchers within the University of Louisiana Monroe based on IRB review and approval.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Upon completion of study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Louisiana Monroe:
Children
Adolescents
Young Adults
Pediatric Hypertension
Pharmacoeconomics
Pharmacist
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases