Tobacco Cessation Via Public Health Dental Clinics (PHD2)
Tobacco Cessation Via Public Health Dental Clinics (PHD2)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The prevalence of tobacco use is especially high in lower socioeconomic status (SES) populations in the U.S. Community Health Centers provide comprehensive primary care services, and usually dental services, to large numbers of low-income smokers and smokeless tobacco users. The typical patient has multiple dental visits, which can be used for tobacco cessation advice and counseling by the dental office team. This study builds on a successful pilot study conducted in two public health dental clinics.
This study is a randomized clinical trial in which 14 public health dental clinics in Oregon, Mississippi, and New York City were stratified by state, matched within state by racial/ethnic composition, and then randomly assigned to either the Intervention or Usual Care Control condition. In the Intervention Condition, the dental team provided a brief intervention modeled on the "5A's" advocated by the Clinical Practice Guideline.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39213
- University of Mississippi
-
-
New York
-
New York, New York, Forenede Stater, 10032
- Columbia University
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97403
- Oregon Research Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients of participating public health dental clinics
- Tobacco users
Exclusion Criteria:
- Emergency patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 2
Dental practitioners provide the following intervention: 5As plus nicotine replacement therapy The 5As consist of: Ask, Advise, Assess, Assist and Arrange. |
Public health dental professionals provide brief counseling during routine visits based on the Clinical Practice Guidelines 5 As (Ask, Advise, Assess, Assist, Arrange), including offering free Nicotine Replacement Therapy and referral to a Tobacco Quit Line.
Pharmacologic: nicotine patch or lozenge maximum 12 week course.
|
|
Ingen indgriben: 1
Usual Care Control: Patients receive treatment as usual.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The primary outcome is prolonged abstinence at 7.5 months following intervention.
Tidsramme: 7.5 months
|
7.5 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Reduction in tobacco use at 6 weeks and 7.5 months following intervention.
Tidsramme: 6 weeks and 7.5 months
|
6 weeks and 7.5 months
|
|
Number of quit attempts at 6 weeks and 7.5 months following intervention.
Tidsramme: 6 weeks & 7.5 months
|
6 weeks & 7.5 months
|
|
Increase in readiness to quit at 6 weeks & 7.5 months following intervention.
Tidsramme: 6 weeks & 7.5 months
|
6 weeks & 7.5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Judith S. Gordon, Ph.D, Oregon Research Institute
Publikationer og nyttige links
Generelle publikationer
- Hinds E, Gordon JS, Widdop CJ. Tobacco Cessation in Public Health Dental Clinics: Short-Term Outcomes for Women. Society of Behavioral Medicine's 29th Annual Meeting and Scientific Sessions in San Diego, California, March 26-29th, 2008.
- Gordon JS, Andrews JA, Albert DA, Crews KM, Payne TJ, Severson HH. Tobacco cessation via public dental clinics: results of a randomized trial. Am J Public Health. 2010 Jul;100(7):1307-12. doi: 10.2105/AJPH.2009.181214. Epub 2010 May 13.
- Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 5R01CA107442-3
- 5R01CA107442 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 .