Optimizing the Clinical Management of Polypharmacy for Children With Medical Complexity: The Pediatric Medication Therapy Management (pMTM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 371
- 试验地点
- 2
- 主要终点
- Medication-Related Problem (MRP) Count
研究概览
简要总结
The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical complexity and polypharmacy.
详细描述
Patients and their parents who meet the study eligibility requirements will be invited to participate in the study. After being informed about the study and potential risks, all patients and their parents giving written informed consent (and assent, when appropriate) will be randomized in a 1:1 ratio to usual care or to the Pediatric Medication Therapy Management (pMTM) intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-18 years old
- •≥1 complex chronic condition (CCC)
- •≥5 current medications (including prescription, as needed, and over-the-counter medications)
- •Receives primary care at Children's Hospital Colorado
排除标准
- •Non-English speaking
- •Sibling or family member already enrolled in this study
研究组 & 干预措施
Usual Care
The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.
Intervention
The intervention group will receive the pMTM study intervention before a routine clinical visit.
干预措施: Pediatric Medication Therapy Management (pMTM) (Other)
结局指标
主要结局
Medication-Related Problem (MRP) Count
时间窗: 90 Days
A MRP is a clearly defined event involving medication therapy that interferes with an optimum outcome for a specific patient, including: inappropriate or unnecessary therapy; suboptimal therapy; undertreated symptom; adverse drug event; major drug-drug interaction; duplication of therapy; or, unclear prescription instruction.
次要结局
- Change in Parent-Reported Outcomes of Symptoms (PRO-Sx) Global Symptom Score(Baseline and 90 Days)
- Acute Healthcare Visit Count(90 Days)