SBIR-STTR Award

Development of a Patient-Facing Portal for the Receipt, Interpretation and Tracking Utility of Pharmacogenetic (PGx) Data
Award last edited on: 2/10/24

Sponsored Program
SBIR
Awarding Agency
NIH : NHGRI
Total Award Amount
$399,593
Award Phase
1
Solicitation Topic Code
172
Principal Investigator
David Krause

Company Information

Genomind Inc

2200 Renaissance Boulevard Suite 100
King Of Prussia, PA 19406
   (740) 244-2542
   N/A
   N/A
Location: Single
Congr. District: 05
County: Montgomery

Phase I

Contract Number: 2023
Start Date: ----    Completed: 9/21/23
Phase I year
2023
Phase I Amount
$399,593
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.

Public Health Relevance Statement:
NARRATIVE In the field of mental health, pharmacogenetics is of particular benefit to facilitate the selection of safe and effective medications, and has the potential to improve patient engagement. Nevertheless, patients' familiarity with pharmacogenetics in psychiatry remains low, demonstrating the need for improved patient-facing materials. This project aims to enhance sustained patient engagement with their genomic information by developing a patient-facing interpretation of a professional pharmacogenetic report to increase patient understanding of pharmacogenetic results, and by facilitating patient-provider communication and shared decision making regarding pharmacogenetic-guided medication selection on an ongoing basis.

Project Terms:
21+ years old; Adult Human; adulthood; Adult; Mental disorders; Mental health disorders; Psychiatric Disease; Psychiatric Disorder; mental illness; psychiatric illness; psychological disorder; Biological Assay; Assay; Bioassay; Biologic Assays; Communication; Communities; Cross-Sectional Studies; Cross Sectional Analysis; Cross-Sectional Analyses; Cross-Sectional Survey; Disease Frequency Surveys; Diagnosis; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electronic Mail; E-Mail; Email; electronic communication; Electronics; electronic; electronic device; Family; Genotype; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Hospitalization; Hospital Admission; Interview; Market Research; Mental Health; Mental Hygiene; Psychological Health; Terminology; Patient Outcomes Assessments; Patient Reported Measures; Patient Reported Outcomes; Patients; Pharmacogenetics; Psychiatry; Psychometrics; Resources; Research Resources; Self Assessment; Computer software; Software; Software Validation; Software Verification; Testing; Time; Translations; translation; Writing; Friends; United States Agency for Healthcare Research and Quality; AHCPR; AHRQ; Agency for Health Care Policy and Research; Agency for Healthcare Research and Quality; United States Agency for Health Care Policy and Research; Universal Precautions; Reminder Systems; Health Costs; Healthcare Costs; Health Care Costs; falls; Schedule; Comprehension; improved; Link; Evaluation; Individual; Genetic; tool; Notification; suicidal; suicidality; System; Adverse reactions; treatment planning; Familiarity; member; Patient Self-Report; Self-Report; outreach; Reporting; Code; Coding System; response; Genomics; Provider; Symptoms; Adherence; Data; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Text; Development; developmental; medication compliance; drug adherence; drug compliance; medication adherence; health literacy; pharmacogenetic testing; designing; design; Outcome; cost effective; commercial application; shared decision making; Regimen; Secure; application program interface; application programming interface; psychiatric symptom; patient-doctor communication; patient-provider communication; patient-clinician communication; participant engagement; patient engagement; patient portal; medication non-adherence; medication nonadherence; remote patient monitoring; provider por

Phase II

Contract Number: 1R43HG013068-01A1
Start Date: 9/20/24    Completed: 00/00/00
Phase II year
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Phase II Amount
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