2021
The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation
D'Onofrio G, Hawk KF, Herring AA, Perrone J, Cowan E, McCormack RP, Dziura J, Taylor RA, Coupet E, Edelman EJ, Pantalon MV, Owens PH, Martel SH, O'Connor PG, Van Veldhuisen P, DeVogel N, Huntley K, Murphy SM, Lofwall MR, Walsh SL, Fiellin DA. The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation. Contemporary Clinical Trials 2021, 104: 106359. PMID: 33737199, PMCID: PMC9153252, DOI: 10.1016/j.cct.2021.106359.Peer-Reviewed Original ResearchConceptsOpioid use disorderRandomized clinical trialsPrimary outcomeFormal addiction treatmentOpioid withdrawalClinical trialsAncillary studiesUse disordersSelf-reported opioid useAddiction treatmentEmergency department initiationIncremental cost-effectiveness ratioReceipt of medicationEmergency department studyHealth service utilizationCost-effectiveness ratioOpioid useSecondary outcomesService utilizationTreatment accessEligibility criteriaImplementation facilitationBuprenorphineOverdose eventsDepartment study
2019
User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial
Melnick ER, Jeffery MM, Dziura JD, Mao JA, Hess EP, Platts-Mills TF, Solad Y, Paek H, Martel S, Patel MD, Bankowski L, Lu C, Brandt C, D’Onofrio G. User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open 2019, 9: e028488. PMID: 31152039, PMCID: PMC6550013, DOI: 10.1136/bmjopen-2018-028488.Peer-Reviewed Original ResearchMeSH KeywordsAdultBuprenorphineCluster AnalysisDecision Support Systems, ClinicalEmergency Service, HospitalFemaleHumansMaleMiddle AgedMulticenter Studies as TopicNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicUnited StatesYoung AdultConceptsOpioid use disorderEmergency departmentSecondary outcomesUse disordersEmergency department-initiated buprenorphineWestern Institutional Review BoardData Safety Monitoring BoardIndependent study monitorsRates of cliniciansRoutine emergency careSafety monitoring boardInstitutional review boardClinical decision support systemClinician prescribingPragmatic clusterPatient characteristicsPeer-reviewed journalsClinical decision supportPrimary outcomeED cliniciansWithdrawal symptomsOngoing treatmentPatients' willingnessMonitoring boardBuprenorphine