2023
Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care
Mukhopadhyay A, Reynolds H, King W, Phillips L, Nagler A, Szerencsy A, Saxena A, Klapheke N, Katz S, Horwitz L, Blecker S. Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care. JACC Heart Failure 2023, 12: 665-674. PMID: 38043045, DOI: 10.1016/j.jchf.2023.11.002.Peer-Reviewed Original ResearchMineralocorticoid antagonistsVolume groupVisit volumeElectronic health record toolsPhysician workloadGuideline-recommended therapiesReduced ejection fractionUsual care armHeart failure carePrespecified subgroup analysisHigh-volume groupCluster-randomized trialLog-binomial modelsBusy practice settingsCare armEHR alertUsual careEjection fractionHeart failureSubgroup analysisEHR toolsNumber of visitsCardiology officePractice settingsStudy periodSample Size Requirements to Test Subgroup-Specific Treatment Effects in Cluster-Randomized Trials
Wang X, Goldfeld K, Taljaard M, Li F. Sample Size Requirements to Test Subgroup-Specific Treatment Effects in Cluster-Randomized Trials. Prevention Science 2023, 25: 356-370. PMID: 37816835, PMCID: PMC11004667, DOI: 10.1007/s11121-023-01590-6.Peer-Reviewed Original ResearchCluster-randomized trialPay-it-forward incentives for hepatitis virus testing in men who have sex with men: a cluster randomized trial
Zhang Y, Li J, Xie Y, Wu D, Ong J, Marley G, Kamarulzaman A, Lu H, Zou F, Smith J, Tucker J, Fu G, Tang W. Pay-it-forward incentives for hepatitis virus testing in men who have sex with men: a cluster randomized trial. Nature Medicine 2023, 29: 2241-2247. PMID: 37640859, DOI: 10.1038/s41591-023-02519-w.Peer-Reviewed Original ResearchConceptsHepatitis B virusCare armHCV testingVirus testingTwo-arm cluster-randomized trialHepatitis C virus testingHepatitis virus testingCluster-randomized trialProportion of menGroup of menAdverse eventsHBV testPrimary outcomeB virusForward armFree testingHCVMenRapid testingSexTrialsArmActive community participationTestingPersonsDesign, implementation and preliminary results of a type-2 hybrid cluster-randomized trial of integrating screening and treatment for major depressive disorder into specialty clinics providing opioid agonist therapies in Ukraine
Machavariani E, Bromberg D, Dumchev K, Dvoriak S, Zeziulin O, Morozova O, Esserman D, Pykalo I, Saichuk N, Ivasiy R, Haddad M, Altice F. Design, implementation and preliminary results of a type-2 hybrid cluster-randomized trial of integrating screening and treatment for major depressive disorder into specialty clinics providing opioid agonist therapies in Ukraine. Contemporary Clinical Trials 2023, 131: 107248. PMID: 37263492, PMCID: PMC10527419, DOI: 10.1016/j.cct.2023.107248.Peer-Reviewed Original ResearchConceptsOpioid agonist therapyMajor depressive disorderCo-occurring disordersAgonist therapyDepressive disorderSpecialty clinicPsychiatric disordersPatient-level outcomesPrevalent psychiatric disordersCluster-randomized trialPoor health outcomesProvider-level dataMDD treatmentTreatment algorithmExperimental armHigh prevalenceDelivery outcomesHealth outcomesSerial surveysClinicPatientsProject ECHOSubstance useMonthsDisordersKeep it up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial
Mustanski B, Saber R, Jones J, Macapagal K, Benbow N, Li D, Brown C, Janulis P, Smith J, Marsh E, Schackman B, Linas B, Madkins K, Swann G, Dean A, Bettin E, Savinkina A. Keep it up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial. Contemporary Clinical Trials 2023, 127: 107134. PMID: 36842763, PMCID: PMC10249332, DOI: 10.1016/j.cct.2023.107134.Peer-Reviewed Original ResearchConceptsHIV riskHybrid effectiveness-implementation clusterCommunity-based organizationsPublic health scaleCluster-randomized trialHIV prevention programsRE-AIM modelHealth technology interventionStudy protocolOutcome measurementsCBO staffHealth ScalePrevention programsEHealth approachesConsolidated FrameworkIntervention implementationTrialsImplementation researchKIUImplementation outcomesYoung menCounty-level population estimatesYMSMConsumer recruitmentMen
2022
The impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam
Regan M, Cheng C, Mboggo E, Larson E, Lema I, Magesa L, Machumi L, Ulenga N, Sando D, Mwanyika-Sando M, Barnhart D, Hong B, Mungure E, Li N, Siril H, Mujinja P, Naburi H, Kilewo C, Ekström A, Geldsetzer P, Fawzi W, Bärnighausen T, Sudfeld C, Spiegelman D. The impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam. Health Policy And Planning 2022, 38: 279-288. PMID: 36377764, PMCID: PMC10019560, DOI: 10.1093/heapol/czac100.Peer-Reviewed Original ResearchConceptsMore ANC visitsCommunity health worker interventionHealth worker interventionAntenatal careANC visitsPragmatic trialHigh-quality antenatal carePragmatic cluster-randomized trialUptake of ANCDar es SalaamWorker interventionLarge-scale pragmatic trialsCluster-randomized pragmatic trialModest beneficial effectStandard of careRoutine health system dataCluster-randomized trialHealth system dataANC uptakeCare armCHW interventionPrimary outcomeIntervention armFirst trimesterPregnant womenEffectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial
Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials 2022, 23: 412. PMID: 35578345, PMCID: PMC9109449, DOI: 10.1186/s13063-022-06374-x.Peer-Reviewed Original ResearchConceptsHypertension managementPrimary carePrimary outcomeDual antihypertensive therapyHypertension Treatment TrialBlood pressure managementGuideline-based treatmentPrimary care sitesCluster-randomized trialUnit of randomizationGuideline-based decision support systemClinical decision support systemAntihypertensive regimensAntihypertensive treatmentUsual careGuideline adherenceBlood pressureMiddle-income countriesTreatment trialsManagement visitsStudy protocolCare sitesPatientsTrialsPressure managementEVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil
Collins MH, Potter GE, Hitchings MDT, Butler E, Wiles M, Kennedy JK, Pinto SB, Teixeira ABM, Casanovas-Massana A, Rouphael NG, Deye GA, Simmons CP, Moreira LA, Nogueira ML, Cummings DAT, Ko AI, Teixeira MM, Edupuganti S. EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil. Trials 2022, 23: 185. PMID: 35236394, PMCID: PMC8889395, DOI: 10.1186/s13063-022-05997-4.Peer-Reviewed Original ResearchConceptsArboviral infectionsMajor global health problemHigh-quality evidenceCluster-randomized trialGlobal health problemNational InstituteEfficacy of WolbachiaWorld Mosquito ProgramArbovirus transmissionOngoing trialsLicensed antiviralsAedes aegypti mosquitoesEffective vaccineTrial designMosquito ProgramSerologic surveillanceHealth problemsHuman infectionsAedes aegyptiInfectionEpidemiologic outcomesVector control activitiesTrialsAegypti mosquitoesAedes mosquitoes
2021
Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis
Cattamanchi A, Reza T, Nalugwa T, Adams K, Nantale M, Oyuku D, Nabwire S, Babirye D, Turyahabwe S, Tucker A, Sohn H, Ferguson O, Thompson R, Shete P, Handley M, Ackerman S, Joloba M, Moore D, Davis J, Dowdy D, Fielding K, Katamba A. Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis. New England Journal Of Medicine 2021, 385: 2441-2450. PMID: 34936740, PMCID: PMC9212879, DOI: 10.1056/nejmoa2105470.Peer-Reviewed Original ResearchConceptsSame-day treatmentSame-day diagnosisHealth centersMolecular testingTuberculosis testingHuman immunodeficiency virus (HIV) infectionDiagnostic strategiesImmunodeficiency virus infectionCommunity health centersCluster-randomized trialTreatment of tuberculosisSecondary outcomesMore patientsPrimary outcomePrompt diagnosisRoutine careEligible adultsIntervention groupIntervention periodHigh burdenVirus infectionIntervention centersControl groupPatientsTuberculosisDesign of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial
Brown T, Rowe T, Lee J, Petito L, Chmiel R, Ciolino J, Doctor J, Fox C, Goldstein N, Kaiser D, Linder J, Meeker D, Peprah Y, Persell S. Design of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial. Contemporary Clinical Trials 2021, 112: 106649. PMID: 34896294, PMCID: PMC8724916, DOI: 10.1016/j.cct.2021.106649.Peer-Reviewed Original ResearchConceptsPrimary care clinicsProstate-specific antigenCo-primary outcomesElectronic health recordsCare clinicsOlder adultsClinician educationParallel armsPragmatic cluster-randomized trialNon-specific reasonsOvertreatment of diabetesClinical decision support interventionHealth recordsPrimary care cliniciansChoosing Wisely campaignLarge regional health systemCluster-randomized trialDecision support interventionsPragmatic clusterRegional health systemOlder patientsStudy armsCare cliniciansDiabetes measuresUrine testingDesign and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data
Jackson CL, Colborn K, Gao D, Rao S, Slater HC, Parikh S, Foy BD, Kittelson J. Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data. Clinical Trials 2021, 18: 582-593. PMID: 34218684, PMCID: PMC8478782, DOI: 10.1177/17407745211028581.Peer-Reviewed Original ResearchConceptsIvermectin mass drug administrationMass drug administrationCluster-randomized trialControl of malariaCluster-randomized trial designDrug AdministrationCrossover designMixed effects modelsTrial designStudy designCluster-level analysisSmall sample sizeCluster-level summariesCluster-level interventionsParallel trialRisk of harmPrimary analysisMalariaAdministrationMixed-effects modelsTrialsLevel interventionsSample sizeAdditional evaluationParallel design
2020
Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well‐Being: The STRIDE Study
Gill TM, Bhasin S, Reuben DB, Latham NK, Araujo K, Ganz DA, Boult C, Wu AW, Magaziner J, Alexander N, Wallace RB, Miller ME, Travison TG, Greenspan SL, Gurwitz JH, Rich J, Volpi E, Waring SC, Manini TM, Min LC, Teresi J, Dykes PC, McMahon S, McGloin JM, Skokos EA, Charpentier P, Basaria S, Duncan PW, Storer TW, Gazarian P, Allore HG, Dziura J, Esserman D, Carnie MB, Hanson C, Ko F, Resnick NM, Wiggins J, Lu C, Meng C, Goehring L, Fagan M, Correa‐de‐Araujo R, Casteel C, Peduzzi P, Greene EJ. Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well‐Being: The STRIDE Study. Journal Of The American Geriatrics Society 2020, 69: 173-179. PMID: 33037632, PMCID: PMC8178516, DOI: 10.1111/jgs.16854.Peer-Reviewed Original ResearchConceptsSerious fall injuriesFall injuriesMultifactorial interventionPhysical functionOutcomes Measurement Information System (PROMIS) AnxietyLeast square mean changePragmatic cluster-randomized trialMean scoreCommunity-living personsIntervention group's mean scoreInjury prevention interventionsPrimary care practicesFalls Efficacy ScaleCluster-randomized trialUsual careElders StudyDisability InstrumentSTRIDE studyDepression ScaleMean changePrevention interventionsHigh riskCare practicesControl groupMeaningful improvementsA Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries
Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. New England Journal Of Medicine 2020, 383: 129-140. PMID: 32640131, PMCID: PMC7421468, DOI: 10.1056/nejmoa2002183.Peer-Reviewed Original ResearchConceptsSerious fall injuriesFall injuriesIntervention groupControl groupUsual careMultifactorial interventionRate of hospitalizationPrimary care practicesCluster-randomized trialCommunity-dwelling adultsFirst-event analysisYears of ageHealth care systemRate of fallElectronic health recordsBaseline characteristicsPrimary outcomeRandomized trialsMean ageEfficacy trialsIndividualized planCare practicesInjuryMultifactorial strategyEvent rates
2019
Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial
Verma M, Kosinski AS, Volk ML, Taddei T, Ramchandran K, Bakitas M, Green K, Green L, Navarro V. Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial. Journal Of Palliative Medicine 2019, 22: s-34-s-43. PMID: 31486722, DOI: 10.1089/jpm.2019.0121.Peer-Reviewed Original ResearchConceptsEnd-stage liver diseaseQuality of lifePalliative careESLD patientsLiver diseaseMulticenter cluster-randomized trialPatients' QOLPatient-caregiver dyadsRoutine outpatient careComparative effectiveness trialHealth care utilizationGoal-concordant careCluster-randomized trialUnit of randomizationPrinciples of PCEligible patientsPC interventionsNew onsetAcute episodeSecondary outcomesSymptom burdenConcordant carePrimary outcomeCare utilizationCaregiver burden
2018
Cost-Effectiveness of a Clinical Childhood Obesity Intervention
Sharifi M, Franz C, Horan C, Giles C, Long M, Ward Z, Resch S, Marshall R, Gortmaker S, Taveras E. Cost-Effectiveness of a Clinical Childhood Obesity Intervention. 2018, 136-152. DOI: 10.1542/9781610022781-cost.Peer-Reviewed Original ResearchPrimary care providersChildhood obesity interventionsBehaviour change supportObesity interventionsObesity prevalenceCare providersPopulation-level prevention strategiesPediatric primary care providersCluster-randomized trialElectronic decision supportMaintenance of effectsElectronic health recordsUsual careChildhood obesityBMI unitsPediatric practiceObesityPrevention strategiesFunctional EHRPopulation reachClinical interventionsIntervention effectsNational implementationIntervention costsHealth records
2017
Cost-Effectiveness of a Clinical Childhood Obesity Intervention
Sharifi M, Franz C, Horan CM, Giles CM, Long MW, Ward ZJ, Resch SC, Marshall R, Gortmaker SL, Taveras EM. Cost-Effectiveness of a Clinical Childhood Obesity Intervention. 2017, 140: e20162998. PMID: 29089403, PMCID: PMC5654390, DOI: 10.1542/peds.2016-2998.Peer-Reviewed Original ResearchConceptsPrimary care providersChildhood obesity interventionsBehaviour change supportObesity interventionsObesity prevalenceCare providersPopulation-level prevention strategiesPediatric primary care providersCluster-randomized trialElectronic decision supportMaintenance of effectsElectronic health recordsUsual careChildhood obesityBMI unitsPediatric practiceObesityPrevention strategiesFunctional EHRPopulation reachClinical interventionsIntervention effectsNational implementationIntervention costsHealth recordsDesign and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record: a randomized trial
Bernstein SL, Rosner J, DeWitt M, Tetrault J, Hsiao AL, Dziura J, Sussman S, O'Connor P, Toll B. Design and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record: a randomized trial. Translational Behavioral Medicine 2017, 7: 185-195. PMID: 28194729, PMCID: PMC5526813, DOI: 10.1007/s13142-017-0470-8.Peer-Reviewed Original ResearchConceptsPatient's primary care providerTobacco dependence treatmentTobacco treatment medicationsElectronic health recordsPrimary care providersState Smokers' QuitlineTobacco use disorderDependence treatmentTreatment medicationsIntervention physiciansProblem listUse disordersOrder setsState tobacco quitlineCluster-randomized trialLong-term cessationElectronic medical recordsInpatient electronic medical recordPatient's problem listSmokers resultsAdult patientsHospital dischargeHospitalized smokersElectronic alertsTobacco treatmentSmall-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial
Abbeddou S, Yakes Jimenez E, Somé J, Ouédraogo J, Brown. K, Hess S. Small-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatrics 2017, 17: 46. PMID: 28152989, PMCID: PMC5288861, DOI: 10.1186/s12887-016-0765-9.Peer-Reviewed Original ResearchConceptsSmall-quantity lipid-based nutrient supplementsNon-intervention cohortLipid-based nutrient supplementsRetinol-binding proteinIntervention cohortAnemia prevalenceIllness treatmentIC childrenYoung Burkinabe childrenLower retinol-binding proteinSoluble transferrin receptorLower anemia prevalenceIron deficiency prevalenceCluster-randomized trialIndicators of ironPackage of interventionsIndicator of vitaminMonths of ageDifferent treatment groupsGroup-wise differencesTwo-stage clusterNIC childrenNutrient supplementsResultsAt baselineBurkinabe children
2016
Patient and Provider Satisfaction With a Comprehensive Strategy to Improve Prevention of Mother-to-Child HIV Transmission Services in Rural Nigeria
Boehmer A, Audet CM, Blevins M, Gebi UI, Wester CW, Vermund SH, Aliyu MH. Patient and Provider Satisfaction With a Comprehensive Strategy to Improve Prevention of Mother-to-Child HIV Transmission Services in Rural Nigeria. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2016, 72: s117-s123. PMID: 27355498, PMCID: PMC5113240, DOI: 10.1097/qai.0000000000001058.Peer-Reviewed Original ResearchConceptsPrevention of motherProvider satisfactionPatient satisfactionWeeks postpartumControl armIntervention sitesChild HIV transmission servicesChild HIV transmission rateMother-infant careCD4 cell countHIV transmission ratesCluster-randomized trialTotal patient satisfactionAntiretroviral therapyHIV careChild transmissionPrescribed treatmentClinician satisfactionHealth personnelLower cadre workersCell countHealth problemsMale involvementProvider rolesProviders' ability
2015
The impact of group prenatal care on pregnancy and postpartum weight trajectories
Magriples U, Boynton MH, Kershaw TS, Lewis J, Rising SS, Tobin JN, Epel E, Ickovics JR. The impact of group prenatal care on pregnancy and postpartum weight trajectories. American Journal Of Obstetrics And Gynecology 2015, 213: 688.e1-688.e9. PMID: 26164694, PMCID: PMC4910388, DOI: 10.1016/j.ajog.2015.06.066.Peer-Reviewed Original ResearchConceptsGroup prenatal carePostpartum weight retentionPrenatal careWeight gain trajectoriesPrenatal distressWeight trajectoriesWeight gainPrenatal depressionMonths postpartumWeight retentionPrepregnancy body mass indexLongitudinal mixed modelingPostpartum weight trajectoriesWeight change trajectoriesWeight loss trajectoriesPregnancy weight gainExcessive weight gainMedical record reviewBody mass indexCommunity health centersCluster-randomized trialEffect of depressionBaseline demographicsMass indexRecord review
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