CT DOSE samenwerking
5 maart 2024 bijgewerkt door: University of California, San Francisco
CT Dosis Optimalisatie en Standaardisatie Endeavour (DOSE) Samenwerking
Dit is een pragmatische, gerandomiseerde, gecontroleerde trial met getrapte wig om de variatie in doses die worden gebruikt voor diagnostische CT te onderzoeken door gegevens over stralingsdosis te bundelen in verschillende zorgverleningssystemen.
Vergelijken van verschillende strategieën voor het verlagen en optimaliseren van de dosis en het identificeren van de barrières en facilitators voor het implementeren van succesvolle dosisoptimalisatiestrategieën en het standaardiseren van de praktijk.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
De onderzoekers maken gebruik van een gerandomiseerde, gecontroleerde trial met getrapte wiggen, verzamelen informatie over de stralingsdosis op CT van alle samenwerkende zorginstellingen en leiden verschillende interventies om de dosis in alle instellingen te optimaliseren. Naast het verzamelen van de CT-stralingsdosisgegevens en het gebruik van deze resultaten om feedback te geven aan de samenwerkende zorginstellingen, zullen ze op elke locatie enquêtes uitvoeren bij verschillende personen, waaronder sleutelinformanten, zoals hoofdradiologen, technologen en medisch fysici. en radiologiebeheerders.
Ze zullen facilitators en belemmeringen vergelijken en identificeren (beoordeeld door middel van enquêtes van deelnemende faciliteiten) die verband houden met succesvolle en mislukte implementatie van dosisoptimalisatie.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
864080
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 99 jaar (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusiecriteria:
- Diagnostische CT-scans van het hoofd, de borst en/of buik/bekken uitgevoerd binnen de onderzoeksperiode
Uitsluitingscriteria:
- niet-diagnostische scans die niet van het hoofd, de borst en/of de buik/het bekken zijn
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Spoor A
Eenvoudig auditrapport; Persoonlijke bijeenkomst (getimed om samen te vallen met de uit meerdere componenten bestaande interventie); Interventie met meerdere componenten
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De eenvoudige audit biedt vergelijking en feedback over stralingsdoses.
De multi-component interventie geeft feedback op maat over noodzakelijke veranderingen plus begeleiding met behulp van methoden voor kwaliteitsverbetering die organisatieverandering mogelijk maken.
Biedt toegang tot experts, gedetailleerde audits, gezamenlijke gesprekken en locatiebezoeken (indien nodig).
Samenwerkend overleg met nadruk op kwaliteitsverbetering.
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Actieve vergelijker: Spoor B
Persoonlijke bijeenkomst (getimed om samen te vallen met het eenvoudige auditrapport); Eenvoudig auditrapport; Interventie met meerdere componenten
|
De eenvoudige audit biedt vergelijking en feedback over stralingsdoses.
De multi-component interventie geeft feedback op maat over noodzakelijke veranderingen plus begeleiding met behulp van methoden voor kwaliteitsverbetering die organisatieverandering mogelijk maken.
Biedt toegang tot experts, gedetailleerde audits, gezamenlijke gesprekken en locatiebezoeken (indien nodig).
Samenwerkend overleg met nadruk op kwaliteitsverbetering.
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Ander: Spoor C
Eenvoudig auditrapport; Interventie met meerdere componenten
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De eenvoudige audit biedt vergelijking en feedback over stralingsdoses.
De multi-component interventie geeft feedback op maat over noodzakelijke veranderingen plus begeleiding met behulp van methoden voor kwaliteitsverbetering die organisatieverandering mogelijk maken.
Biedt toegang tot experts, gedetailleerde audits, gezamenlijke gesprekken en locatiebezoeken (indien nodig).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Verandering in gemiddelde effectieve dosis (ED)
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering in de gemiddelde effectieve dosis beoordelen na de eenvoudige audit en interventies met meerdere componenten (MCI) in vergelijking met vóór de audit en interventies met meerdere componenten.
De onderstaande cijfers weerspiegelen de absolute verandering in de gemiddelde dosis (in millisievert) ten opzichte van de basislijnperiode.
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Percentage CT-scans met een effectieve dosis boven de benchmark
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering beoordelen in het percentage onderzoeken met een effectieve dosis boven de benchmark na de eenvoudige audit en na multi-component interventie (MCI) in vergelijking met doses vóór de audit en MCI.
De benchmark voor elk anatomisch gebied wordt gedefinieerd als het 75e percentiel van de dosisverdeling tijdens de pre-interventieperiode (basislijn).
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Gemiddelde dosislengteproduct
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering in het dosislengteproduct na de audit en MCI beoordelen in vergelijking met vóór de audit en MCI.
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Aandeel CT-scans met een dosislengteproduct boven de benchmark
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering beoordelen in het aandeel onderzoeken met een dosislengteproduct boven de benchmark na de audit en na de MCI in vergelijking met doses vóór de audit en MCI.
De benchmark voor elk anatomisch gebied wordt gedefinieerd als het 75e percentiel van de dosisverdeling tijdens de periode vóór de interventie.
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Verandering in gemiddeld volume computertomografiedosisindex (CTDIvol)
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering in de gemiddelde volume CT-dosisindex (CTDIvol) beoordelen van vóór versus na de audit en MCI-interventie.
CTDIvol (in milligray, mGy) is een maatstaf voor de stralingsdosis, die de hoeveelheid straling weergeeft die per CT-schijfje door de scanner wordt afgegeven.
Een hoger CTDIvol betekent een hogere stralingsdosis.
Over het algemeen zou een vermindering van CTDIvol een teken zijn van kwaliteitsverbetering, waardoor overmatige blootstelling aan straling van de patiënt tot een minimum wordt beperkt.
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Percentage CT-scans met een CTDIvol boven de benchmark
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering beoordelen in het percentage onderzoeken met een CTDIvol boven de benchmark na de audit en na interventie met meerdere componenten in vergelijking met de doses vóór de audit en interventie met meerdere componenten.
De benchmark voor elk anatomisch gebied wordt gedefinieerd als het 75e percentiel van de dosisverdeling tijdens de periode vóór de interventie.
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Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Verandering in gemiddelde orgaandoses: hersendosis voor hoofd-CT; Longdosis voor CT van de borst; Colon- en leverdosis voor buik-CT
Tijdsspanne: Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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We zullen de verandering in orgaandoses beoordelen na de eenvoudige audit en multi-component interventies (MCI) in vergelijking met vóór de audit en multi-component interventies.
De onderstaande cijfers weerspiegelen de absolute verandering in de gemiddelde dosis (in millisievert) ten opzichte van de basislijnperiode.
|
Locaties werden gerandomiseerd naar 1 van de 3 sporen, die de timing van de interventie bepaalden: Track A: audit in week 40, MCI in week 68 Track B: audit in week 44, MCI in week 74 Track C: audit in week 53, MCI in week 81
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rebecca Smith-Bindman, MD, University of California, San Francisco
- Hoofdonderzoeker: Judy Yee, MD, San Francisco Veterans Administration
- Hoofdonderzoeker: Tom Nelson, PhD, University of California, San Diego
- Hoofdonderzoeker: Tony Seibert, PhD, University of California, Davis
- Hoofdonderzoeker: Mayil Krishnam, MD, University of California, Irvine
- Hoofdonderzoeker: Michael Flynn, PhD, Henry Ford Health System
- Hoofdonderzoeker: Mary Cocker, MSc, Csci, Oxford University Hospitals NHS Trust
- Hoofdonderzoeker: William Boswell, MD, City of Hope Medical Center
- Hoofdonderzoeker: Sebastian Schindera, MD, University Hospital of Basel
- Hoofdonderzoeker: Erin Bell, MHP, Community Health Network
- Hoofdonderzoeker: Phuong-Anh Duong, MD, Emory University
- Hoofdonderzoeker: Nima Kasraie, PhD, MSc, Children's Mercy Hospital Kansas City
- Hoofdonderzoeker: Pavlina Pike, PhD, Huntsville Hospital
- Hoofdonderzoeker: Luisa Cervantes, MD, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Hoofdonderzoeker: Joachim Wildberger, PhD, Maastricht University Medical Center
- Hoofdonderzoeker: Michael Forsting, MD, University of Duisburg-Essen
- Hoofdonderzoeker: Fady Kassem, PhD, St. Joseph Hospital of Orange
- Hoofdonderzoeker: Darrell Fendrick, CT, East Texas Medical Center
- Hoofdonderzoeker: Sugoto Mukherjee, MD, University of Virginia Health System
- Hoofdonderzoeker: Brad Delman, MD, ICAHN School of Medicine at Mount Sinai
- Hoofdonderzoeker: Jodi Roehm, Center For Diagnostic Imaging
- Hoofdonderzoeker: Anokh Pahwa, MD, Olive View - UCLA
- Hoofdonderzoeker: Ryan Lee, MD, MBA, Einstein Medical Center
- Hoofdonderzoeker: Jay Starkey, MD, St. Luke's International Hospital, Tokyo
- Hoofdonderzoeker: Diana Miglioretti, PhD, University of California, Davis
- Hoofdonderzoeker: Saravanabavaan Suntharalingam, MD, University of Duisburg-Essen
- Hoofdonderzoeker: Sara Lewis, MD, ICAHN School of Medicine at Mount Sinai
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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- Smith-Bindman R, Chu P, Wang Y, Chung R, Lopez-Solano N, Einstein AJ, Solberg L, Cervantes LF, Yellen-Nelson T, Boswell W, Delman BN, Duong PA, Goode AR, Kasraie N, Lee RK, Neill R, Pahwa A, Pike P, Roehm J, Schindera S, Starkey J, Suntharalingam S, Jeukens CRLPN, Miglioretti DL. Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):666-675. doi: 10.1001/jamainternmed.2020.0064.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2016
Primaire voltooiing (Werkelijk)
1 december 2020
Studie voltooiing (Werkelijk)
1 december 2020
Studieregistratiedata
Eerst ingediend
12 december 2016
Eerst ingediend dat voldeed aan de QC-criteria
19 december 2016
Eerst geplaatst (Geschat)
22 december 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 maart 2024
Laatste update ingediend die voldeed aan QC-criteria
5 maart 2024
Laatst geverifieerd
1 maart 2024
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- RSB-181191
- R01CA181191 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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