Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Satisfaction With Genomic Test Report
研究概览
简要总结
Current lab reports are designed to communicate results from the laboratory to the provider; they are not designed to be accessible to patients. The investigators believe that a new type of genomic test report, tailored for patient- as well as provider-use, will enable patients to have access to information they can understand allowing them to be more involved in the management of their disorders, better navigate the health care system, and make more informed decisions about their health and health care in conjunction with their providers. This approach has the potential to improve outcomes from both the patient and provider perspectives.
The investigators propose to study the research question, "Can a genomic laboratory report tailored for both providers and families of patients improve interpretation of complex results and facilitate recommended care by enhancing communication and shared decision making?"
详细描述
This is a mixed-methods will be conducted in multiple phases:
Phase 1: development of an enhanced genomic test result report through in-depth interviews with parents and providers
Phase 2: refine the report through parental focus groups and provider interviews and create the final report and delivery method.
Phase 3: implement the enhanced test report and evaluate the impact on patient and providers
Subjects for the study are parents of affected children enrolled in the Whole Genome Sequencing (WGS) Clinical Research Pilot Study (study within a study). All parents receive routine clinical care for WGS and clinical return of results per protocol of the WGS study.
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 (Participant)
盲法说明
participants do not know whether they are in the intervention (enhanced report) or control (routine clinical care with delayed access to the enhanced report) arm
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Research participants who are consented to participate in the WGS Study (#2012-0187).
- •Providers who have referred participants to the WGS Study (#2012-0187) and who have participated in the WGS genomic medicine workgroup or who have participated in the WGS Program Oversight Committee.
排除标准
- •Participants who are not consented to participate in the WGS Study (#2012-0187)
- •Providers who have not referred patients to the WGS Study (#2012-0187).
- •Providers who have not had a relationship with the oversight of the WGS study (#2012- 0187).
研究组 & 干预措施
Enhanced genomic report
routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study
干预措施: enhanced genomic report (Other)
Control with delayed access
routine clinical care for return of results per whole genome sequencing study and no intervention through three months. This arm will crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report
干预措施: enhanced genomic report (Other)
结局指标
主要结局
Satisfaction With Genomic Test Report
时间窗: 3 months after receipt of enhanced report
3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.
次要结局
未报告次要终点
研究者
Marc S. Williams
Director, Genomic Medicine Institute
Geisinger Clinic