grant

A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Organization BOSTON MEDICAL CENTERLocation BOSTON, UNITED STATESPosted 30 Sept 2024Deadline 31 Aug 2026
NIHUS FederalResearch GrantFY202421+ years oldActiqActive Follow-upAddressAdolescentAdolescent Risk BehaviorAdolescent YouthAdolescent and Young AdultAdultAdult HumanAgeAwarenessBehavioralBenzodiazepine CompoundsBenzodiazepinesBostonCessation of lifeChildhoodCollaborationsCommunitiesConduct Clinical TrialsControl GroupsCounselingDataDeathDeath RateDevelopmentDrowningDrug usageDrugsDuragesicEnsureExclusion CriteriaExposure toFamilyFamily PracticeFentanestFentanylFentylFirearmsHealth BenefitHealth Care ProvidersHealth PersonnelHealthcare ProvidersHealthcare workerHistoryHomeIndividualInjuryInterventionIntervention StrategiesKnowledgeLearningMeasuresMedical centerMedicationModelingMotivationNaloxoneNarcanNarcantiOutcomeOverdoseOverdose reductionPharmaceutical PreparationsPhentanylPositionPositioning AttributePreparednessPreventative interventionPreventionPrevention educationPrimary CareProceduresProviderPublic HealthRandomization trialRandomizedRandomized, Controlled TrialsReadinessRecommendationRecording of previous eventsRiskRisk ReductionSafetyScienceStimulantTestingTimeTranslatingTreatment EfficacyTrustUnited StatesYouthYouth 10-21Youth Risk Behavioracceptability and feasibilityactive followupadolescent risk takingadolescent substance useadulthoodagedagesarmchild health care providerchild healthcare providercommunity advisory boardcommunity advisory committeecommunity advisory panelcommunity engagementcost effectivedesigndesigningdetermine efficacydevelop therapydevelopmentaldrug usedrug/agentefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationengagement with communitiesevaluate efficacyevidence baseexamine efficacyexperiencefamily medicinefollow upfollow-upfollowed upfollowupgroup interventionhealth care personnelhealth care settingshealth care workerhealth providerhealth workforcehealthcare personnelhealthcare settingshistorieshomesimprovedinjuriesinjury preventionintervention developmentintervention efficacyintervention for preventioninterventional strategyjuvenilejuvenile humanlife year lossmanufacturemedical personnelmortality ratemortality ratiomultiple substance usemultisubstance usenovelopiate consumptionopiate drug useopiate intakeopiate useopioid consumptionopioid drug useopioid intakeopioid useoverdose deathoverdose fatalitiesoverdose preventionoverdose riskpediatricpediatric care providerpediatric health care providerpediatric healthcare providerpediatric providerpediatricianpillpilot trialpoly substance usepolysubstance useprevention interventionpreventional intervention strategypreventive interventionprimary care providerprimary care settingprimary outcomeproviders from primary careproviders of primary carerandomisationrandomizationrandomized control trialrandomized trialrandomly assignedreduce overdosereduce riskreduce risksreduce that riskreduce the riskreduce these risksreduces riskreduces the riskreducing riskreducing the riskreduction in overdoseresponserisk behavior in youthrisk-reducingsecondary outcomeskillsstandard of caresubstance use among adolescentssubstance use among youththerapeutic efficacytherapy developmenttherapy efficacytreatment developmenttreatment providertrial designyears of life lostyouth substance use
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Full Description

PROJECT SUMMARY/ABSTRACT
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and

young adults (“youth”), and the percent change in fatal overdose death rates among adolescents was higher

than adults between 2019 and 2020. Similar to adults, illicitly manufactured fentanyl (IMF) is the major driver of

drug overdose deaths in youth. Unlike adults, youth are more commonly exposed to IMF through counterfeit

pills, and some youth are unaware that they are using a pill that is counterfeit and thus unintentionally exposed

to IMF. Unfortunately, any youth who uses a counterfeit pill or other drug is at risk for an overdose, even after

first use. There is an urgent need for evidence-based overdose prevention interventions for youth. Within the

healthcare setting, youth primary care providers routinely provide injury prevention anticipatory guidance as

part of annual comprehensive physical exams and are well positioned to provide anticipatory guidance for

overdose prevention. Through this R61/R33 mechanism we propose to develop and evaluate the efficacy of an

universal overdose prevention intervention that will increase: (1) awareness of the risks of fentanyl and other

emerging drugs in the drug supply, (2) knowledge of strategies to reduce overdose risk, and (3) recognition

and response to overdose. In the R61, in collaboration with our existing Youth Community Advisory Board, we

proposed to use the Informational-Motivational-Behavioral Skills Model to develop an overdose prevention

intervention to be delivered in primary care setting. We will pilot the intervention in two primary care settings at

Boston Medical Center, Pediatric Primary Care and Family Medicine, to assess acceptability and feasibility for

providers and youth ages 13 to 26 years who are being seen for an annual comprehensive physical exam. We

will do this through a pilot two-arm cluster randomized controlled trial (RCT) that is randomized at the provider

level. During the pilot trial, we will share preliminary data with the Community Advisory Board to inform any

needed adaptations to the intervention. If the intervention is acceptable and feasible to providers we will

transition to evaluating the intervention’s efficacy in a larger RCT during the R33. In the R33, we will again

conduct a two-arm cluster RCT randomized at the provider level using the same inclusion/exclusion criteria,

procedures, and study measures as the R61. Youth outcomes will be evaluated at one-year follow up and the

primary outcome will be youth knowledge of the risk associated with fentanyl and other emerging drugs in the

drug supply. Secondary outcomes will include youth knowledge of strategies to reduce overdose risk,

recognize and respond to an overdose. If the universal youth overdose prevention intervention is effective this

will benefit youth and public health generally as youth will be better prepared to decrease their risk for

overdose, and recognize and respond to others who have an overdose.

Grant Number: 1R61DA062217-01
NIH Institute/Center: NIH

Principal Investigator: Sarah Bagley

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