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- Klinische proef NCT00464009
Development and Evaluation of a Medical Intervention for Early Childhood Caries (IMB-RCT)
28 januari 2010 bijgewerkt door: University of North Carolina, Chapel Hill
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Practice-based, randomized controlled trial.
Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years.
Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish.
Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support.
Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support.
Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance.
Primary outcome measure: rate of preventive dental services provision per 100 well-child visits.
Secondary outcome measure: % of practices providing 20 or more preventive dental visits.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
North Carolina
-
Chapel Hill, North Carolina, Verenigde Staten, 27955
- UNC-CH, School of Public Health
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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
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- pediatric or family physician Medicaid practice in North Carolina
Exclusion Criteria:
- participation in related pilot study
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 |
|---|---|
|
Actieve vergelijker: A
Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish.
|
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application.
Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices.
The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices.
Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
|
Actieve vergelijker: B
Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support.
|
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application.
Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices.
The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices.
Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
|
Actieve vergelijker: C
Group C practices (n=41) received the same as Group B and were also offered in-office follow-up visits providing hands-on advice and support.
|
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application.
Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices.
The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices.
Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Rate of preventive dental services provision per 100 well-child visits.
Tijdsspanne: One year following initial training.
|
One year following initial training.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Percent of practices providing 20 or more preventive dental visits.
Tijdsspanne: One year following initial training.
|
One year following initial training.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
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
- Quinonez RB, Pahel BT, Rozier RG, Stearns SC. Follow-up preventive dental visits for Medicaid-enrolled children in the medical office. J Public Health Dent. 2008 Summer;68(3):131-8. doi: 10.1111/j.1752-7325.2007.00055.x.
- Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.
- Slade GD, Rozier RG, Zeldin LP, Margolis PA. Training pediatric health care providers in prevention of dental decay: results from a randomized controlled trial. BMC Health Serv Res. 2007 Nov 2;7:176. doi: 10.1186/1472-6963-7-176.
- Rozier RG, Slade GD, Zeldin LP, Wang H. Parents' satisfaction with preventive dental care for young children provided by nondental primary care providers. Pediatr Dent. 2005 Jul-Aug;27(4):313-22.
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
1 februari 2001
Primaire voltooiing (Werkelijk)
1 april 2002
Studie voltooiing (Werkelijk)
1 november 2007
Studieregistratiedata
Eerst ingediend
19 april 2007
Eerst ingediend dat voldeed aan de QC-criteria
19 april 2007
Eerst geplaatst (Schatting)
20 april 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
29 januari 2010
Laatste update ingediend die voldeed aan QC-criteria
28 januari 2010
Laatst geverifieerd
1 september 2009
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11-P-91251/4-02
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 .