Development of a Patient-Facing Portal for the Receipt, Interpretation and Tracking Utility of Pharmacogenetic (PGx) Data

开发面向患者的门户网站，用于药物遗传学 (PGx) 数据的接收、解释和跟踪实用程序

• 批准号: 10758862
• 负责人: Daniel Dowd
• 金额: $ 39.96万
• 依托单位: GENOMIND, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2024-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10758862
• 关键词: Adherence; Adult; Adverse reactions; Biological Assay; Code; Communication; Communities; Comprehension; Computer software; Cross-Sectional Studies; Data; Development; Diagnosis; Electronic Mail; Electronics; Evaluation; Familiarity; Family; Friends; Genetic; Genomics; Genotype; Health Care Costs; Health Personnel; Hospitalization; Individual; Interview; Link; Market Research; Mental Health; Mental disorders; Notification; Outcome; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacogenetics; Provider; Psychiatry; Psychometrics; Regimen; Reminder Systems; Reporting; Resources; Schedule; Secure; Self Assessment; Software Validation; Symptoms; System; Terminology; Testing; Text; Time; Translations; United States Agency for Healthcare Research and Quality; Universal Precautions; Writing; application programming interface; commercial application; cost effective; design; falls; health literacy; improved; medication compliance; medication nonadherence; member; outreach; patient engagement; patient portal; patient-clinician communication; pharmacogenetic testing; provider portal; psychiatric symptom; remote patient monitoring; response; shared decision making; suicidal; tool; treatment planning

ABSTRACT Selection of medication for mental illness is generally through trial-and-error, with high rates of adverse reactions and sub-optimal efficacy. Pharmacogenetic (PGx) data is thus of particular benefit to facilitate selection of safe and effective medications and is cost effective, decreases resource utilization, and improves patient engagement, with the potential to overcome medication non-adherence. Nevertheless, in the field of psychiatry, patients' familiarity with PGx remains low, demonstrating the need for improved patient-facing PGx materials. The objective of this project is to enhance sustained patient engagement with their genomic information by: a) increasing patient understanding of PGx results by developing a consumer-focused patient report; and b) facilitating patient-provider communication and shared decision making using PGx-guided medication selection on an ongoing basis by increasing patient self-reporting of psychiatric symptoms using regularly administered psychometric scales that are communicated to healthcare providers in real time. This ongoing self-reporting will serve as the entry point to discussions regarding changes to medication regimens, which will be explained to patients using the consumer-focused PGx report. Ongoing and consistent patient-provider communication is known to reinforce patient engagement, further encouraging patient use of the tracking system. Provider use will be encouraged through the billing codes available for remote patient monitoring. This project has three Specific Aims. Aim 1 is to develop a PGx report that is more accessible to individuals without a biomedical background. The Professional PGx assay report will be adapted using the AHRQ Health Literacy Universal Precautions Toolkit, following which a user comprehension study will be conducted to assess understanding of the report by lay individuals. Aim 2 is to integrate outcome tracking scales within the patient portal to support voluntary tracking of patient outcomes longitudinally and ongoing shared decision making with healthcare providers. For this aim, diagnosis-specific psychometric scales will be integrated into the patient platform, together with a patient reminder system that will send text/email reminders to patients every 2 weeks with a link to the psychometric scales, as well as a reminder system for a designated community member to further encourage patient engagement. An alert system will also be developed to notify patients and designated community members if scores change by >30% between evaluations, prompting the patient to speak to their healthcare provider. User acceptance testing (UAT) will be performed to verify that the systems operate as intended. Aim 3 is to develop an application programming interface (API) to report patients’ longitudinal psychometric scoring directly to the healthcare provider portal to facilitate patient-provider communication and ongoing PGx-guided medication choice. A provider alert system based on patients’ self-reported outcomes, including indications of suicidality, will also be developed, followed by UAT. Successful project completion will, for the first time, combine longitudinal patient outcome tracking and PGx guidance, for both patients and providers, in the mental health field.

抽象的 精神疾病药物的选择一般是通过反复试验，不良反应发生率较高 因此，药物遗传学（PGx）数据对于促进安全的选择特别有益。 和有效的药物，具有成本效益，减少资源利用率，并改善患者 然而，在精神病学领域，参与有可能克服药物不依从性， 患者对 PGx 的熟悉程度仍然较低，这表明需要改进面向患者的 PGx 材料。 该项目的目标是通过以下方式增强患者对其基因组信息的持续参与：a) 通过制定以消费者为中心的患者报告，增加患者对 PGx 结果的了解；b) 使用 PGx 指导的药物选择促进患者与提供者的沟通和共同决策 通过定期服用药物，增加患者对精神症状的自我报告，持续进行 这种持续的自我报告将实时传达给医疗保健提供者。 作为有关药物治疗方案改变的讨论的切入点，这将被解释给 患者使用以消费者为中心的 PGx 报告 持续且一致的患者与提供者沟通是。 已知可以加强患者参与，进一步鼓励患者使用提供者使用的跟踪系统。 通过可用于远程患者监控的计费代码来鼓励该项目有三个具体内容。 目标 1 是开发一份可供没有生物医学背景的个人更容易理解的 PGx 报告。 专业 PGx 检测报告将根据 AHRQ 健康素养通用预防措施进行调整 工具包，随后将进行用户理解研究，以评估对报告的理解 目标 2 是将结果跟踪量表集成到患者门户中以支持自愿跟踪。 纵向评估患者结果并与医疗保健提供者持续共同决策。 诊断特定的心理测量量表将与患者一起集成到患者平台中 提醒系统每两周向患者发送短信/电子邮件提醒，并附有心理测量的链接 量表，以及指定社区成员的提醒系统，以进一步鼓励患者 还将开发一个警报系统，以通知患者和指定的社区成员。 评估之间的分数变化超过 30%，促使患者与其医疗保健提供者用户交谈。 将进行验收测试 (UAT)，以验证系统是否按预期运行。 一个应用程序编程接口（API），可将患者的纵向心理测量评分直接报告给 医疗保健提供者门户，促进患者与提供者之间的沟通和持续的 PGx 指导用药 基于患者自我报告结果（包括自杀迹象）的提供者警报系统， 也将进行开发，随后项目的成功完成将首次将纵向结合起来。 在心理健康领域，为患者和提供者提供患者结果跟踪和 PGx 指导。