Development and Evaluation of a Medical Intervention for Early Childhood Caries (IMB-RCT)
28. januar 2010 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27955
- UNC-CH, School of Public Health
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- pediatric or family physician Medicaid practice in North Carolina
Exclusion Criteria:
- participation in related pilot study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rate of preventive dental services provision per 100 well-child visits.
Tidsramme: One year following initial training.
|
One year following initial training.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent of practices providing 20 or more preventive dental visits.
Tidsramme: One year following initial training.
|
One year following initial training.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2001
Primær fullføring (Faktiske)
1. april 2002
Studiet fullført (Faktiske)
1. november 2007
Datoer for studieregistrering
Først innsendt
19. april 2007
Først innsendt som oppfylte QC-kriteriene
19. april 2007
Først lagt ut (Anslag)
20. april 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. januar 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. januar 2010
Sist bekreftet
1. september 2009
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-P-91251/4-02
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