Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Proportion of patients with adequately-controlled hypertension at 3 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Proportion of patients with adequately-controlled hypertension at 3 months.
时间窗: 3 months
Proportion of patients with adequately-controlled hypertension at 12 months.
时间窗: 12 months
Time to adequate control of hypertension.
时间窗: Through study completion, an average of 1 year.
Defined as the first appointment with controlled hypertension.
Proportion of patients with adequately-controlled hypertension at 6 months.
时间窗: 6 months
次要结局
- Costs to communities(Through study completion, an average of 1 year.)
- Appointment adherence(Through study completion, an average of 1 year.)
- Number and type of serious adverse drug events(Through study completion, an average of 1 year.)
- Number of unplanned health care encounters related to hypertension(Through study completion, an average of 1 year.)
- Costs to patients(Through study completion, an average of 1 year.)
- Cost to healthcare systems and payors(Through study completion, an average of 1 year.)