This document discusses utilizing electronic health information technology (eHIT) for HIV/AIDS clinical pharmacology and implementation research. It provides an overview of eHIT, including electronic medical records, electronic health records, and electronic prescribing. It describes how eHIT can be used for medication management, monitoring patient outcomes, and managing disease complexity. The document also explores applications of eHIT in clinical research, such as identifying potential participants, facilitating data collection and monitoring safety. Overall, the document argues that eHIT systems have the potential to improve HIV/AIDS treatment and research.

1. Utilizing Electronic Health Information Technology to Conduct HIV/AIDS Clinical Pharmacology and Implementation Research: Introductory ModuleSamuel Gavi, MSc – AITRP Fellow, UZCharles C. Maponga PharmD, AITRP Co-Principal Investigator, UZCara Felton, PharmD – AITRP Mentor, UBFarzia Sayidine- AITRP Research Support, UBPulkit Bhuptani PharmD - Research Student, UB Kathleen M. Tooley , MSEd- AITRP Program Administrator, UBRobin DiFrancesco, MBA – AITRP Mentor, UBGene D. Morse, PharmD – AITRP Principal Investigator, UB1University at Buffalo/University of Zimbabwe AIDS International Training And Research ProgramA Collaboration of the University at Buffalo, University of Zimbabwe, NYS Center of Excellence in Bioinformatics and Life Sciences, and the Institute for Healthcare Informatics

2. IntroductionGoal:To become familiar with applications of electronic Health Information Technology (eHIT) in HIV/AIDS, TB and other infectious disease researchThis module will explore the following:Overview of electronic health information technologyAdvantages and disadvantages of using electronic health information technologySpecialized fields of application of health information technologyApplications of eHIT in HIV/AIDS therapeutics research and implementation science in clinical practice2

3. Overview of Electronic Health Information Technology3

4. Electronic Health Information Technology (eHIT)eHIT may consist of:Electronic medical recordsElectronic health recordsElectronic prescribingPersonal Health recordseHIT can:Comprehensively manage patient medical records Allow for secure exchange of information between health care providersProvide patient-centered health system that continuously improves health outcomes for individuals and the population4

5. eHIT System 5Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

6. eHIT System 6Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

7. Electronic Medical Records (EMR)An application environment composed of:Clinical data repositoryClinical decision supportControlled medical vocabularyComputerized provider order entry, pharmacy, and clinical documentationEMRs are used by healthcare practitioners to document, monitor, and manage health care delivery Used within an institution or system7

8. Components of an EMRAncillary clinical services, including:LaboratoryRadiologyPharmacy recordsComputerized physician order entry (CPOE)Error checking capabilitiesOrder entryReport and document adverse eventsClinical documentation, including:Nursing notesConsult notes8

9. eHIT System 9Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

10. Electronic Health Records (EHR)Distinguished from EMR as it may be shared among different organizationsCan be seen as a constellation of a patient’s EMRs accumulated from the same or various health care institutions over a period of time10

11. Components of an EHRPatient demographics History and physicalAllergies ImmunizationsLaboratory testsMedical imagingMedication history Pharmacy recordsInformation from multiple providers/ institutions11

12. eHIT System 12Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

13. Electronic PrescribingePrescribing is the process whereby an authorized health care prescriber generates a computer-based prescription and transmits it electronically to a pharmacyComputer to computerePrescribing is not:Computer to faxComputer-generated paper prescriptionThis system can be integrated into an EMR ePrescribing can also be used for research protocols13

14. Types of ePrescribing Systems Stand-alone system: Simpler and cheaper to install as compared to a complete EMR packageIntegrated system: Consists of an electronic prescribing module integrated into an EMR systemContains all pertinent medical information within one comprehensive system 14

15. eHIT System 15Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

16. Using eHIT for Medication ManagementManagement of HIV/AIDS and co-infections presents medication complexities Ex. Interactions, adverse events, increased dosing frequency and pill burdeneHIT can be used to identify precautionary and prohibited medications during screening and protocol implementationInnovative programming within EHRs could allow for calculating the impact of medication complexities on ARV treatment outcomes16

17. Using eHIT for Medication ManagementMedication information: Automated alert systems for:Adverse eventsDrug-drug and drug-disease interactionsSpecial instructions:Food and timing considerationsAdministrationDrug formulation Route of administrationFrequency17

18. eHIT System 18Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

19. Patient Centered OutcomesPatient outcomes:Result of clinical decision making from evidence based best practicesEvidence based best practices: Derived from clinical research resultsClinical research results:Studies designed around research hypothesisResearch hypothesis:Research questions arise from patient outcomesAdverse drug reactions and toxicities can be monitored to enhance subject safety during protocols19

20. Using eHIT to Manage Disease ComplexityDisease complexity in an HIV/AIDS patient can be determined using all available clinical and laboratory patient dataData from EHRs can be used to monitor disease complexity and progressionPatient demographics HIV serologyComplete blood count with differentialBlood chemistriesResistance tests (genotypic and phenotypic assays)Additional serologic screeningIncluding disease complexity may allow for the detection of individual drug efficacy or toxicity among subjects20

21. eHIT System 21Clinical Presentation and Diagnosis Diagnostics – Laboratory Data Management SystemElectronic Health RecordElectronic Medical RecordsElectronic PrescribingMedication ManagementPatient Centered outcomesTreatment Biomarkers Translational applications in clinical research, clinical practice, pharmacoepidemiology, pharmacoinformatics, pharmacogenomics and implementation science

22. Applications of eHIT in Clinical Pharmacology and Implementation ResearchIdentification of potential research opportunitiesIdentification of potential trial participantsFacilitate screening based on inclusion/exclusion criteriaCreation of trial-specific data fieldsFacilitation of data submission Eliminate redundancy and increase accuracy22

23. Applications of eHIT in Clinical Pharmacology and Implementation ResearchMore efficient and extensive patient data collectionImproved external validity Representative of the source population Cost considerations:Lower patient monitoring costs during the trialLower start up time and costs of clinical researchExisting network infrastructure23

24. Applications of eHIT in Clinical Pharmacology and Implementation ResearchEHRs provide:Improved participant recruitment and enrollmentParticipant identificationBroad, diverse populationPopulation health surveillanceAcross exposures, interventions, and outcomesExposure/outcome associationsOutcomes research24

25. EHR Data in Clinical Pharmacology and Implementation Research Engage more people in researchMore robust informationEnable access to advanced treatmentReduce errors in dataCollective data across trialsEfficient data collectionEliminate redundancy in data collectionSafety reporting – real time dataFacilitate sharing of informationImprove communication between partnering organizations25

26. EHR Data in Clinical Pharmacology and Implementation ResearchHow data are collected/generatedStrengthen provider/investigator relationshipPatient inputConsider health literacy, access to careDifferent purposes for data collection/generation26

27. EHR Data in Clinical Pharmacology and Implementation ResearchQuality of data collectionWhat to collectWhere to collect How to collect When to collect Why to collect27

28. Data Collection - Case Report Forms Official data-reporting document used in clinical trialsCollects protocol-required informationCRFs allow for:Standardization of information Sharing of data among investigatorsEHR data may be used to pre-populate CRFsEliminate transcription errorsEliminate redundancy in data collection28

29. EHR Data in Clinical Pharmacology and Implementation ResearchExchange of dataEncourage sharing of dataResponsible use of data by all participating organizationsEncourage standardization of dataCollection, storage, retrieval, and analysis 29

30. Additional Considerations Regarding eHIT SystemsSecurity of patient data:Different levels of access for different usersCompatibility:Multiple institutions using different eHIT systemsRegulatory bodies:Issues concerning security, sharing, and use of patient data Data requirements:Differing requirements between the EHR and a clinical trial30

31. eHIT in HIV/AIDS Treatment and ResearchUse of eHIT systems has the potential to improve HIV/AIDS treatment by:Increasing adherence to treatment regimensMinimizing patients lost to follow-upSupporting clinical decisions Minimizing medication errors (interactions, duplications, additive adverse events)31

32. Information Technology Used in HIV Treatment and ResearchInformation technology can be used for effective management of HIV, TB, and other infectious diseasesNetworked computersSmall basic databases using Microsoft Excel or Access for large databasesInternet-based databases Laboratory data management systemsUse of portable electronic devices in medication management32

33. Electronic health information technology applications provide a continuous feedback loop to optimize patient health outcomes and drive clinical researchModel for eHIT Facilitated Clinical Pharmacology and Implementation Research

34. Supplemental Reading MaterialsFDA guidelines for drug developmentHIPAA and clinical researchJohnson George et al developed the Medication Regimen Complexity Index, a useful tool that can be useful for patients on ARV therapy to determine impact of medication complexities on treatment outcomes CollenDilorio et al tested the antiretroviral medication complexity index (AMCI) to assess the psychometric properties of the AMCI34

35. AcknowledgmentsNational Institutes of Health Fogarty International Center 1D43TW007991-01A2National Institutes of Health, Fogarty International Center 3D43TW007991-01A2S1We would like to acknowledge Ms. Amal Harb and Mr. Francesco Lliguicota for their informatics assistance on this project. We would also like to acknowledge the Adherence Pharmacology Unit at the Erie County Medical Center for their clinical mentorship to AITRP fellows.35

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