Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
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|ClinicalTrials.gov Identifier: NCT04098978|
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2019
Last Update Posted : January 23, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|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|
|Experimental: Pharmacist Drug Therapy Management||
Other: Pharmacist Drug Therapy Management
Patients will be seen by pharmacist for collaborative drug therapy management.
- 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.
- 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. ]
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
|United States, Louisiana|
|Ochsner Health Center for Children|
|West Monroe, Louisiana, United States, 71292|