CT DOSE Samarbejde
CT Dosis Optimization and Standardization Endeavour (DOSE) Collaboratory
Dette er et pragmatisk, randomiseret, kontrolleret klyngeforsøg, der skal udforske variation i doser, der bruges til diagnostisk CT, ved at samle strålingsdosisdata på tværs af forskellige sundhedssystemer.
At sammenligne forskellige strategier til at sænke og optimere dosis og identificere barrierer og facilitatorer for at implementere succesfulde dosisoptimeringsstrategier og standardiseringspraksis.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Forskerne bruger et randomiseret, kontrolleret forsøg med stepped-wedge klynge, der indsamler information om strålingsdosis på CT fra alle samarbejdende sundhedsfaciliteter og leder adskillige forskellige interventioner for at optimere dosis på tværs af faciliteter. Ud over at indsamle data om CT-strålingsdosis og bruge disse resultater til at give feedback til de samarbejdende sundhedsfaciliteter, vil de udføre undersøgelser af flere personer på hvert sted, herunder nøgleinformanter, såsom ledende radiologer, teknologer og medicinsk fysiker og radiologiadministratorer.
De vil sammenligne og identificere facilitatorer og barrierer (vurderet gennem undersøgelser af deltagende faciliteter) forbundet med vellykket og mislykket implementering af dosisoptimering.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Diagnostiske CT-scanninger af hoved, bryst og/eller mave/bækken udført inden for undersøgelsesperioden
Ekskluderingskriterier:
- ikke-diagnostiske scanninger, der ikke er af hoved, bryst og/eller mave/bækken
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Aktiv komparator: Spor A
Simpel revisionsrapport; Personligt møde (tidsindstillet til at falde sammen med multikomponent-interventionen); Multikomponentintervention
|
Den simple audit giver sammenligning og feedback på stråledoser.
Multikomponent-interventionen giver skræddersyet feedback om nødvendige ændringer plus vejledning ved hjælp af kvalitetsforbedringsmetoder, der letter organisatoriske ændringer.
Giver adgang til eksperter, detaljeret revision, samarbejdsopkald og webstedsbesøg (efter behov).
Samarbejdsmøde med vægt på kvalitetsforbedring.
|
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Aktiv komparator: Spor B
Personligt møde (tidsbestemt til at falde sammen med den simple revisionsrapport); Simpel revisionsrapport; Multikomponentintervention
|
Den simple audit giver sammenligning og feedback på stråledoser.
Multikomponent-interventionen giver skræddersyet feedback om nødvendige ændringer plus vejledning ved hjælp af kvalitetsforbedringsmetoder, der letter organisatoriske ændringer.
Giver adgang til eksperter, detaljeret revision, samarbejdsopkald og webstedsbesøg (efter behov).
Samarbejdsmøde med vægt på kvalitetsforbedring.
|
|
Andet: Spor C
Simpel revisionsrapport; Multikomponentintervention
|
Den simple audit giver sammenligning og feedback på stråledoser.
Multikomponent-interventionen giver skræddersyet feedback om nødvendige ændringer plus vejledning ved hjælp af kvalitetsforbedringsmetoder, der letter organisatoriske ændringer.
Giver adgang til eksperter, detaljeret revision, samarbejdsopkald og webstedsbesøg (efter behov).
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i gennemsnitlig effektiv dosis (ED)
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i den gennemsnitlige effektive dosis efter den simple audit og multi-komponent interventioner (MCI) i forhold til før audit og multi-komponent interventioner.
Tallene nedenfor afspejler den absolutte ændring i middeldosis (i millisievert) i forhold til basislinjeperioden.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
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Procentdel af CT-scanninger med en effektiv dosis over benchmark
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i procentdelen af undersøgelser med en effektiv dosis over benchmark efter den simple audit og efter multi-komponent intervention (MCI) sammenlignet med doser før audit og MCI.
Benchmark for hvert anatomisk område er defineret som den 75. percentil af dosisfordelingen i præ-interventionsperioden (baseline).
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Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Middeldosislængdeprodukt
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i dosislængdeproduktet efter audit og MCI i forhold til før audit og MCI.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
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Andel af CT-scanninger med et dosislængdeprodukt over benchmark
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i andelen af undersøgelser med et dosislængdeprodukt over benchmark efter audit og efter MCI i forhold til doser før audit og MCI.
Benchmark for hvert anatomisk område er defineret som den 75. percentil af dosisfordelingen i præ-interventionsperioden.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
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Ændring i middelvolumen beregnet tomografidosisindeks (CTDIvol)
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i middelvolumen CT dosisindeks (CTDIvol) fra før versus efter audit og MCI intervention.
CTDIvol (i enheder af milligrå, mGy) er et mål for strålingsdosis, der afspejler mængden af stråling, der afgives pr. CT-skive af scanneren.
Højere CTDIvol betyder mere stråledosis.
Generelt vil en reduktion i CTDIvol være et tegn på kvalitetsforbedring, hvilket minimerer overskydende strålingseksponering for patienten.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
|
Procentdel af CT-scanninger med en CTDIvol over benchmark
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i procentdelen af undersøgelser med et CTDIvol over benchmark efter audit og efter multikomponent intervention i forhold til doser før audit og multikomponent intervention.
Benchmark for hvert anatomisk område er defineret som den 75. percentil af dosisfordelingen i præ-interventionsperioden.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
|
Ændring i gennemsnitlige organdoser: hjernedosis for hoved-CT; Lungedosis til CT-thorax; Kolon- og leverdosis til abdomen-CT
Tidsramme: Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
|
Vi vil vurdere ændringen i organdoser efter den simple audit og multi-komponent interventioner (MCI) i forhold til før audit og multi-komponent interventioner.
Tallene nedenfor afspejler den absolutte ændring i middeldosis (i millisievert) i forhold til basislinjeperioden.
|
Stederne blev randomiseret til 1 af 3 spor, som bestemte tidspunktet for intervention: Spor A: audit i uge 40, MCI i uge 68 Spor B: audit i uge 44, MCI i uge 74 Spor C: audit i uge 53, MCI kl. uge 81
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Rebecca Smith-Bindman, MD, University of California, San Francisco
- Ledende efterforsker: Judy Yee, MD, San Francisco Veterans Administration
- Ledende efterforsker: Tom Nelson, PhD, University of California, San Diego
- Ledende efterforsker: Tony Seibert, PhD, University of California, Davis
- Ledende efterforsker: Mayil Krishnam, MD, University of California, Irvine
- Ledende efterforsker: Michael Flynn, PhD, Henry Ford Health System
- Ledende efterforsker: Mary Cocker, MSc, Csci, Oxford University Hospitals NHS Trust
- Ledende efterforsker: William Boswell, MD, City of Hope Medical Center
- Ledende efterforsker: Sebastian Schindera, MD, University Hospital of Basel
- Ledende efterforsker: Erin Bell, MHP, Community Health Network
- Ledende efterforsker: Phuong-Anh Duong, MD, Emory University
- Ledende efterforsker: Nima Kasraie, PhD, MSc, Children's Mercy Hospital Kansas City
- Ledende efterforsker: Pavlina Pike, PhD, Huntsville Hospital
- Ledende efterforsker: Luisa Cervantes, MD, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Ledende efterforsker: Joachim Wildberger, PhD, Maastricht University Medical Center
- Ledende efterforsker: Michael Forsting, MD, University of Duisburg-Essen
- Ledende efterforsker: Fady Kassem, PhD, St. Joseph Hospital of Orange
- Ledende efterforsker: Darrell Fendrick, CT, East Texas Medical Center
- Ledende efterforsker: Sugoto Mukherjee, MD, University of Virginia Health System
- Ledende efterforsker: Brad Delman, MD, ICAHN School of Medicine at Mount Sinai
- Ledende efterforsker: Jodi Roehm, Center For Diagnostic Imaging
- Ledende efterforsker: Anokh Pahwa, MD, Olive View - UCLA
- Ledende efterforsker: Ryan Lee, MD, MBA, Einstein Medical Center
- Ledende efterforsker: Jay Starkey, MD, St. Luke's International Hospital, Tokyo
- Ledende efterforsker: Diana Miglioretti, PhD, University of California, Davis
- Ledende efterforsker: Saravanabavaan Suntharalingam, MD, University of Duisburg-Essen
- Ledende efterforsker: Sara Lewis, MD, ICAHN School of Medicine at Mount Sinai
Publikationer og nyttige links
Generelle publikationer
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Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- RSB-181191
- R01CA181191 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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