Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 798
- 试验地点
- 2
- 主要终点
- Participants' opinions of pharmacogenetic testing changes after results are received
研究概览
简要总结
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video.
详细描述
This study will follow a two-arm unblinded research design. Study inclusion criteria include ability to provide a DNA sample for pharmacogenetic (PGx) testing and willingness to receive the test results. All participants will have PGx testing. Participants will complete a survey at study baseline, which will collect demographic information (age, race/ethnicity), contact and alternative contact information, primary care physician information, socioeconomic details (e.g. insurance information, education, occupation, marital status, and income) health data (e.g. chronic conditions, personal and family history of genetic diseases) and lifestyle data (e.g. smoking, drinking, and physical activity). Parents will complete enrollment surveys on behalf of children. Basic health and pregnancy history will also be collected for pregnant women. Survey questions regarding information and knowledge on PGx testing will be administered at enrollment and again after return of PGx results. Participants will be randomized to either the intervention group or the delayed intervention group. Individuals in the intervention group will be provided an educational video about PGx testing at the time that PGx results are available. Participants in the Delayed intervention group will be provided the educational video after they complete the first follow up survey. The investigators will include questions in the follow-up survey specific to the educational video in the first follow up survey (Intervention group) or the second follow up survey (Delayed intervention group).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Provide consent in English or Spanish
- •Primary care at VUMC
- •Adult women aged 18 and older
- •Currently pregnant 12 to 30 weeks gestational age
- •Completed or scheduled first prenatal visit at VUMC clinic
- •Intent to deliver at VUMC or affiliate
- •Agrees to receive findings from pharmacogenomic testing
- •Allow access their medical record
排除标准
- •Stem cell or solid organ transplant
- •Recent transfusion within the previous 2 months
- •Inability to provide DNA sample for testing
- •Prior pharmacogenomic testing
- •Pregnant women undergoing in vitro fertilization or assisted reproductive technologies
- •Inclusion Criteria:
- •Provide consent (parent/guardian) and/or assent (child) in English or Spanish
- •Primary care or subspecialty care at VUMC
- •Aged 0 to 16
- •Parent (0-16 years) and child (12-16 years) agree for both parent and child to receive findings from pharmacogenomic testing
- •Parent (0-16 years) and child (12-16 years) allow access their medical record
- •Have a chronic health condition.
- •Stem cell or solid organ transplant
- •Recent transfusion within the previous 2 months
- •Inability to provide DNA sample for testing
- •Prior pharmacogenomic testing
研究组 & 干预措施
Intervention arm
All individuals in the Intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Upon completion of the testing, they will be provided a link to an educational video about pharmacogenetic testing and results. Surveys will be performed before and after the pharmacogenetic testing.
干预措施: Educational video (Other)
Delayed intervention arm
All individuals in the Delayed intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Surveys will be performed before and after the pharmacogenetic testing. Upon completion of the first follow up survey, they will be provided a link to an educational video about pharmacogenetic testing and results. A second follow up survey will then be completed.
干预措施: Educational video (Other)
结局指标
主要结局
Participants' opinions of pharmacogenetic testing changes after results are received
时间窗: Baseline to post-return of PGx results, approximately 2- 4 weeks
* Opinion of Knowledge of Pharmacogenetics (PGx) and Related Terminology is being collected in 3 ways. Ten words or phrases will be assessed using a 5-variable ordinal scale ('Not at all familiar' to 'Extremely familiar'). One question will use a 4-variable ordinal scale (Very well, somewhat well, a little, not at all). Another question will use a 5-option Likert scale (A lot, somewhat, a little, not at all, don't know). * Opinion of the Usefulness of PGx Testing is being collected using 12 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). * Opinion of What Can be Learned from PGx Test Results is being collected using 9 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). For all 3 above, responses reflect relative value, not absolute value, so are not additive and there are no total scores.
次要结局
- Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions(Baseline to post-return of PGx results, approximately 2- 4 weeks)
- Participants gain an improved knowledge of pharmacogenetics after educational intervention(Baseline to post-return of PGx results, approximately 2-4 weeks)
研究者
Digna Velez Edwards
Associate Professor of Pediatrics and Medicine
Vanderbilt University Medical Center