Fremme af retningslinjer og håndtering af astma gennem teknologibaseret intervention og plejekoordinering (PRAGMATIC)
3. oktober 2025 opdateret af: Montefiore Medical Center
Det overordnede mål med denne forskningsundersøgelse er at teste effektiviteten af en multifacetteret og multi-niveau-tilskyndende intervention i en virkelig verden af urban primær pleje kontorer med henblik på at forbedre udbyder-leveret guideline-baseret astma pleje og reducere astma morbiditet blandt bybørn med vedvarende eller ukontrolleret astma.
Studieoversigt
Detaljeret beskrivelse
Efterforskere vil udføre et randomiseret klyngeforsøg, der sammenligner interventionen med forbedret sædvanlig pleje (eUC) i 20 Bronx-praksis, der betjener over 5.000 børn i alderen 2-12 år med vedvarende eller ukontrolleret astma. Elleve eUC-praksis vil modtage retningslinjer og vurdere børns astmas sværhedsgrad og kontrol, men aktive interventionskomponenter vil ikke blive leveret. Praksis vil deltage i undersøgelsen i 4 bølger over 4 år (4-6 praksis pr. år). Udbyderens vedtagelse af retningslinjer og brug af pleje hos alle patienter (~5.000) i alderen 2-12 år med vedvarende eller ukontrolleret astma fra intervention og eUC-praksis vil blive evalueret ved hjælp af elektroniske sundhedsjournaler (EPJ) data og praksisbaseret screening for astmas sværhedsgrad og styring. Efterforskere vil også tilmelde en tilfældig delmængde af 512 omsorgspersoner til børn med vedvarende/ukontrolleret astma fra begge undersøgelsesarme for systematisk at evaluere pårørende-rapporterede børns sygelighedsresultater og opnå mål, der ikke er tilgængelige i EPJ.
Intervention består af akademiske detaljer i EPJ, der følger nationale astmaretningslinjer og koordinering af opsøgende plejepersonale for patienter med vedvarende eller ukontrolleret astma.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
530
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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The Bronx, New York, Forenede Stater, 10467
- Children's Hospital at Montefiore, Albert Einstein College of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Kriterierne nedenfor vil gælde for ~5.000 børn fra eMPI og eUC praksis:
- Læge-diagnosticeret astma (baseret på EPJ).
- Vedvarende eller ukontrolleret astma ifølge klinikvurdering. Baseret på NHLBI-retningslinjer, en af følgende: i den seneste måned, > 2 dage/ugen med astmasymptomer, >2 dage/ugen med brug af redningsmedicin, >2 dage/måneden med nattesymptomer eller > 2 episoder i fortiden år, der krævede systemiske kortikosteroider.
- Alder 2 og 12 år inklusive.
Yderligere inklusionskriterier vil gælde for en undergruppe af 512 børn, hvis omsorgspersoner vil blive interviewet for at opnå omsorgsgiver-rapporterede sygelighedsresultater:
- Pårørende er i stand til at tale og forstå enten engelsk eller spansk. Deltagere, der ikke kan læse, vil være kvalificerede, da alle undersøgelser vil blive administreret mundtligt af forskningspersonale.
- Samtykke fra den primære omsorgsperson, omsorgsgiverens tilladelse til barnets deltagelse samt samtykke fra barnet (>7 år). Hvis der er berettigede søskende, vil kun ét barn blive udvalgt tilfældigt.
Ekskluderingskriterier:
- Barnet har andre væsentlige medicinske tilstande, såsom medfødt hjertesygdom, cystisk fibrose eller anden kronisk lungesygdom, der kan forstyrre vurderingen af astma-relaterede tiltag.
Yderligere eksklusionskriterier vil gælde for en undergruppe af 512 børn/plejere som beskrevet ovenfor:
- Ingen adgang til en telefon til at udføre opfølgende undersøgelser.
- Børn i plejefamilie eller andre situationer, hvor der ikke kan indhentes samtykke fra en værge.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Enhanced Multifaceted Prompting Intervention (eMPI)
Det forbedrede MPI-program (eMPI) består af innovative multi-level og team-baserede strategier for at gøre det muligt for udbydere effektivt og effektivt at vedtage retningslinjer for astmabehandling.
eMPI bruger guideline-baserede prompter på tidspunktet for et kontorbesøg for at understøtte udbyderes beslutningstagning, hvilket øger sandsynligheden for, at de vil anbefale korrigerende handlinger (dvs. ordination af forebyggende medicin) for at forbedre astmahåndteringen.
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Kerneelementerne i flerniveaustrategien for implementering omfatter: Direkte support til udbyderes levering af retningslinjebaseret pleje i praksis; Forbedringer for at øge gennemførligheden og bæredygtigheden af eMPI; Inddragelse af klinikpersonale i at fremme og understøtte brugen af retningslinjer; Opbygning af ansvarlighed og forpligtelse til retningslinjebaseret pleje; Fremme af udbyderes forståelse, accept og brug af retningslinjer |
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Ingen indgriben: Enhanced Usual Care (eUC)-praksis
Deltagerne vil modtage en gennemgangspakke med retningslinjerne fra det nationale astmauddannelses- og forebyggelsesprogram (NAEPP) og uddannelsesressourcer til familier.
Børn vil blive vurderet for astmas sværhedsgrad og kontrolniveau ved hvert besøg som en del af bedste praksis, men aktive interventionskomponenter vil ikke blive leveret.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Procentdel af deltagere med 1 eller flere retningslinjebaserede korrigerende handlinger
Tidsramme: Umiddelbart efter indgreb, op til 1 år
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Procentdelen af deltagere, der har truffet 1 eller flere guideline-baserede korrigerende handlinger (dvs. ordination eller justering af controllermedicin, trigger-evaluering), som registreret i den elektroniske patientjournal (EPJ), rapporteres.
Resultaterne er opsummeret i antal/procentdel af deltagere med 1 eller flere retningslinjebaserede korrigerende handlinger udført af undersøgelsesarmen.
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Umiddelbart efter indgreb, op til 1 år
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Symptomfrie dage (SFD'er)
Tidsramme: Baseline og 3 måneders, 6 måneders, 9 måneders og 12 måneders opfølgningsevalueringer
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Antallet af dage uden symptomer i løbet af de seneste 14 dage er opsummeret af undersøgelsesarm ved baseline og hver 3. måned op til 12 måneders opfølgningsevaluering.
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Baseline og 3 måneders, 6 måneders, 9 måneders og 12 måneders opfølgningsevalueringer
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pædiatrisk astma Caregiver's Quality of Life Questionnaire (PACQLQ)
Tidsramme: hver 3. måned op til 12 måneder
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pårørende astma relateret livskvalitet
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hver 3. måned op til 12 måneder
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Udnyttelse af sundhedspleje: Antal ED-besøg for astma
Tidsramme: hver 3. måned op til 12 måneder
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antal akutte besøg for astma
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hver 3. måned op til 12 måneder
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Udnyttelse af sundhedsvæsenet: Antal indlæggelser for astma
Tidsramme: hver 3. måned op til 12 måneder
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antal indlæggelser for astma
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hver 3. måned op til 12 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marina Reznik, MD, MS, Montefiore Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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- Garbutt JM, Yan Y, Highstein G, Strunk RC. A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity. J Allergy Clin Immunol. 2015 May;135(5):1163-70.e1-2. doi: 10.1016/j.jaci.2014.09.033. Epub 2014 Oct 30.
- Rapkin BD, Weiss ES, Lounsbury DW, Thompson HS, Goodman RM, Schechter CB, Merzel C, Shelton RC, Blank AE, Erb-Downward J, Williams A, Valera P, Padgett DK. Using the interactive systems framework to support a quality improvement approach to dissemination of evidence-based strategies to promote early detection of breast cancer: planning a comprehensive dynamic trial. Am J Community Psychol. 2012 Dec;50(3-4):497-517. doi: 10.1007/s10464-012-9518-6.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. marts 2017
Primær færdiggørelse (Faktiske)
24. august 2024
Studieafslutning (Faktiske)
24. august 2024
Datoer for studieregistrering
Først indsendt
16. februar 2017
Først indsendt, der opfyldte QC-kriterier
23. februar 2017
Først opslået (Faktiske)
28. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Anslået)
21. oktober 2025
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2025
Sidst verificeret
1. oktober 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-6258
- 1R01HL133789 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Efterforskere vil dele de-identificerede data ved hjælp af datadelingsaftale-processen, efter at undersøgelsen er afsluttet, og manuskripter til hovedundersøgelsens formål er blevet offentliggjort.
IPD-delingstidsramme
I overensstemmelse med NIH Data Management and Sharing (DMS) Politik vil "rettidig frigivelse og deling" af IPD-data blive overvejet senest ved accept for offentliggørelse af de vigtigste resultater fra det endelige datasæt, hvilket giver mulighed for "en rimelig henstandsperiode" (30-60 dage) som beskrevet i Politikken.
Data vil være tilgængelige i en periode på op til XX år.
IPD-delingsadgangskriterier
Adgang til BDC kontrolleres af NHLBI Data Access Committee (DAC), som bruger databasen over Genotyper og Fænotyper (dbGaP) tilladelsesinfrastruktur. For at få adgang til data med kontrolleret adgang i BDC skal en efterforsker have en godkendt Data Access Request (DAR) i dbGaP. DAC vil gennemgå og godkende (eller afvise) efterforsker-indsendte DAR'er for at sikre efterforskerens overholdelse af datadelingspolitikken.
Data og tilhørende dokumentation vil kun blive gjort tilgængelig for brugere under en datadelingsaftale, der kræver:
- modtageren ikke at overføre dataene til andre brugere;
- dataene skal kun bruges til forskningsformål;
- forpligtelse til ikke at manipulere data med det formål at identificere et individuelt individ;
- foreslået forskning ved hjælp af de data, der skal gennemgås af en IRB;
- forpligtelse til at sikre data ved hjælp af passende computerteknologi;
- forpligtelse til at destruere eller returnere dataene, efter at analyserne er afsluttet.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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