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 精神疾病的药物选择通常是通过反复试验的，不良反应率很高 和亚最佳效率。因此，药物遗传学（PGX）数据特别有益于促进安全的选择 和有效的药物，具有成本效益，减少资源利用并改善患者 参与，有可能克服药物不遵守。然而，在精神病学领域， 患者对PGX的熟悉程度仍然很低，这表明需要改善面向患者的PGX材料。 该项目的目的是通过以下方式增强患者与基因组信息的持续参与。 通过开发以消费者为中心的患者报告来增强患者对PGX结果的理解；和b） 使用PGX指导的药物选择支持患者提供沟通和共同决策 通过使用定期给药的患者自我报告的精神病症状来持续不断增加 实时传达给医疗保健提供者的心理测量量表。这种持续的自我报告将会 作为有关更改药物治疗方案的讨论的切入点，将向 使用以消费者为中心的PGX报告的患者。持续且一致的患者提供沟通是 已知可以增强患者参与度，进一步鼓励患者使用跟踪系统。提供者使用会 通过可用于远程患者监控的计费代码来鼓励。这个项目有三个特定的 目标。 AIM 1是开发一个PGX报告，该报告更容易被没有生物医学背景的个人访问。 专业PGX分析报告将使用AHRQ健康素养通用预防措施进行调整 工具包，然后将进行用户摘要研究以评估该报告对报告的理解 外行个人。 AIM 2是在患者门户中整合结果跟踪量表以支持自愿跟踪 与医疗保健提供者进行纵向和持续共享决策的患者结局。为此， 诊断特异性的心理测量量表将与患者一起集成到患者平台中 提醒系统将每2周向患者发送文本/电子邮件提醒，并通过心理测量 秤，以及指定社区成员进一步鼓励患者的提醒系统 订婚。如果 评估之间的分数变化> 30％，促使患者与他们的医疗保健提供者交谈。用户 将执行接受测试（UAT），以验证系统是否按预期运行。目标3是发展 申请编程接口（API），以直接报告患者的纵向心理测量评分 医疗保健提供者门户网站，以促进患者提供者的沟通和正在进行的PGX引导药物 选择。根据患者自我报告的结果，包括自杀的指示，提供者警报系统， 也将开发，然后是UAT。成功的项目完成将首次结合纵向 精神健康领域中的患者和提供者的患者结果跟踪和PGX指导。