2024
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
Marsolo K, Cheville A, Melnick E, Jarvik J, Simon G, Sluka K, Crofford L, Staman K, Richesson R, Schlaeger J, Curtis L. Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials. Contemporary Clinical Trials 2024, 148: 107744. PMID: 39561918, DOI: 10.1016/j.cct.2024.107744.Peer-Reviewed Original ResearchElectronic health record systemsElectronic health recordsPragmatic clinical trialsElectronic health record platformsDelivery of interventionsHealth recordsTrial interventionMonitoring of interventionsRecord updatesStudy teamMonitoring outcomesClinical trialsInterventionLocal implementationTechnological evolutionTeamDynamic natureTrialsDeliveryCase exampleSystem
2022
Pragmatic clinical trial design in emergency medicine: Study considerations and design types
Gettel CJ, Yiadom MYAB, Bernstein SL, Grudzen CR, Nath B, Li F, Hwang U, Hess EP, Melnick ER. Pragmatic clinical trial design in emergency medicine: Study considerations and design types. Academic Emergency Medicine 2022, 29: 1247-1257. PMID: 35475533, PMCID: PMC9790188, DOI: 10.1111/acem.14513.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trial designTrial designReal-world clinical practicePragmatic clinical trial designElectronic health recordsEmergency departmentClinical trialsStudy design typeClinical practiceStudy typeTrial componentsHealth recordsEmergency medicineEmergency medicine investigatorsHuman subjects concernsInvestigatorsStudy findingsStudy considerationsTrialistsTrials
2021
57 EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder
Melnick E, Casey M, Dziura J, Jeffery M, Soares W, Hoppe R. 57 EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder. Annals Of Emergency Medicine 2021, 78: s23. DOI: 10.1016/j.annemergmed.2021.09.066.Peer-Reviewed Original ResearchAccounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies
Tuzzio L, Meyers CM, Dember LM, Grudzen CR, Melnick ER, Staman KL, Huang SS, Richards J, DeBar L, Vazquez MA, Green BB, Coronado GD, Jarvik JG, Braciszewski J, Ho PM, Wells BL, James K, Toto R, D’Onofrio G, Volandes A, Kuklinski MR, Catalano RF, Sterling SA, Morse EF, Curtis L, Larson EB. Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies. Healthcare 2021, 8: 100432. PMID: 34175091, PMCID: PMC8900087, DOI: 10.1016/j.hjdsi.2020.100432.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsQI initiativesHealthcare systemClinical trialsHigh-quality patient-centered careClinical practice guidelinesHigh-quality evidencePatient-centered careQuality of careQuality improvement activitiesPractice guidelinesRoutine collaborationHealth questionsHealth systemTrialsHealth system operationsConduct phaseCareStudy teamPublic healthInterventionImprovement activitiesEPCTs