跳至主要内容
临床试验/NCT07060300
NCT07060300Enrolling By Invitation不适用

Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
1
主要终点
Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing

研究概览

简要总结

The goal of this clinical trial is to determine the feasibility and acceptability of Pharmacogenetic Testing, and the attitudes towards the same in caregivers of complex care patients in Cincinnati, OH. The main question[s] it aims to answer are:

  1. With financial and access barriers removed, do caregivers of complex care patients agree to receive Pharmacogenetic testing for their children?
  2. With financial and access barriers removed, what are some remaining barriers to implementation of pharmacogenetics testing?
  3. What are the prevailing attitudes towards Pharmacogenetic testing in the complex care population?

Participants will be offered pharmacogenetic testing for their child free of charge, and will be asked to fill out a voluntary survey. Certain caregivers of complex care patients may be asked if they want to participate in a short semi-structured interview.

详细描述

Through this research, the investigators expect to have successfully provided pharmacogenetic testing to a large cohort of patients in Cincinnati Children's Complex Care Clinic, allowing for an improved understanding of how to provide pharmacogenetic testing in children with medical complexity (feasibility) and of caregiver attitudes about pharmacogenetic testing for their children (acceptability). The knowledge gained from this study will be used to inform future program implementations in children with medical complexity (CMC) populations. Successfully tested patients will also provide for future studies to measure the effectiveness of pharmacogenetic testing in this population, as well as prescriber behavior when provided pharmacogenetic testing results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients who score a 3 on the Pediatric Medical Complexity Algorithm
  • •Patients whose primary care providers are those at the Cincinnati Children's Complex Care Clinic
  • •Patients attending the Cincinnati Children's Hospital Complex Care Clinic for well child visit
  • •Patients attending the Cincinnati Children's Hospital Complex Care Clinic for chronic care management visits
  • •Legal Guardian is present at time of clinical visit

排除标准

  • •Patients attending the Complex Care Clinic for acute illness.
  • •Patients who have previously received Pharmacogenetic Testing.
  • •Patients deemed ineligible for approach by the clinical team.
  • •Patients who are wards of the state.

研究组 & 干预措施

Accept Pharmacogenetic Testing

Experimental

Caregivers who agree to receive Pharmacogenetic testing for their child

干预措施: Agree to Pharmacogenetic Testing (Other)

结局指标

主要结局

Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing

时间窗: Day 1

What portion of caregivers accept pharmacogenetic testing for their children when the barriers of access and financial burden are removed

次要结局

  • Barriers to acceptance of Pharmacogenetic testing(6 months)
  • Facilitators to acceptance of pharmacogenetic testing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonya Tang Girdwood

Associate Professor of Pediatrics

Children's Hospital Medical Center, Cincinnati

研究点 (1)

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