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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

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE January 14, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Proportion of patients with adequately-controlled hypertension at 3 months. [ Time Frame: 3 months ]
  • Proportion of patients with adequately-controlled hypertension at 6 months. [ Time Frame: 6 months ]
  • Proportion of patients with adequately-controlled hypertension at 12 months. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Proportion of patients with adequately-controlled hypertension at 6 months. [ Time Frame: 6 months ]
  • Proportion of patients with adequately-controlled hypertension at 12 months. [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Appointment adherence [ Time Frame: Through study completion, an average of 1 year. ]
    Proportion of appointments attended
  • 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.
  • 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.
  • Costs to patients [ Time Frame: Through study completion, an average of 1 year. ]
    Includes direct medical, direct nonmedical, indirect costs
  • Costs to communities [ Time Frame: Through study completion, an average of 1 year. ]
    Includes healthcare resource utilization, lost productivity
  • Cost to healthcare systems and payors [ Time Frame: Through study completion, an average of 1 year. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Appointment adherence [ Time Frame: Through study completion, an average of 1 year. ]
    Proportion of appointments attended
  • Serious adverse drug events [ Time Frame: Through study completion, an average of 1 year. ]
  • 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.
  • Costs to patients [ Time Frame: Through study completion, an average of 1 year. ]
    Includes direct medical, direct nonmedical, indirect costs
  • Costs to communities [ Time Frame: Through study completion, an average of 1 year. ]
    Includes healthcare resource utilization, lost productivity
  • Cost to healthcare systems and payors [ Time Frame: Through study completion, an average of 1 year. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
Official Title  ICMJE Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Hypertension
  • Blood Pressure
Intervention  ICMJE Other: Pharmacist Drug Therapy Management
Patients will be seen by pharmacist for collaborative drug therapy management.
Study Arms  ICMJE Experimental: Pharmacist Drug Therapy Management
Intervention: Other: Pharmacist Drug Therapy Management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04098978
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Upon completion of study.
Responsible Party University of Louisiana Monroe
Study Sponsor  ICMJE University of Louisiana Monroe
Collaborators  ICMJE Ochsner Health System
Investigators  ICMJE Not Provided
PRS Account University of Louisiana Monroe
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP