Engaging Patients in Tobacco Cessation Resources in Dental Settings (ENGAGE)
22. juni 2022 oppdatert av: HealthPartners Institute
A Clinic-randomized Trial of a Clinical Decision Support System to Improve Dental Provider Delivery of Brief Tobacco Interventions and Quitline Referrals
The overarching goal of this project is to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling.
Using a stratified, group-randomized, controlled, 2-arm trial conducted in two settings, the investigators will compare smoking-related clinical decision support (CDS) to usual care.
Studieoversikt
Detaljert beskrivelse
This project aims to reduce smoking-associated morbidity and mortality by increasing the number of patients who are referred for tobacco cessation counseling.
The study team will evaluate the effectiveness of clinical decision support (CDS) to improve dental provider delivery of brief tobacco interventions and referrals to tobacco quitlines for further tobacco counseling.
The CDS will generate personalized, evidence-based recommendations for dentists and dental hygienists to actively engage their smoking patients in the course of usual dental care.
Subsequently, the study team will assess the tobacco cessation actions of smokers using patient-centered outcomes.
Studietype
Intervensjonell
Registrering (Faktiske)
56
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University School of Dentistry
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Minnesota
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Bloomington, Minnesota, Forente stater, 55425
- HealthPartners Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15261
- University of Pittsburgh School of Dental Medicine
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
DENTAL STUDENTS AND DENTAL HYGIENE STUDENTS
Inclusion Criteria:
- 3rd and 4th year predoctoral students or dental hygiene students enrolled at selected dental schools
PRIVATE PRACTICE DENTISTS & HYGIENISTS
Inclusion Criteria:
- General practice dentists or dental hygienists practicing at selected private practice clinics
Exclusion Criteria:
- Providers not able or willing to record current tobacco use status in their electronic health record
- Providers affiliated with selected dental schools who hold a current teaching or clinical position
PATIENTS
Inclusion Criteria:
- Current cigarette smokers
Exclusion Criteria:
- patients requesting to opt out of research
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: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Usual Care
Usual care, practitioners review clinical guidelines for tobacco during consent process.
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Eksperimentell: Clinical Decision Support
The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care.
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The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment
Tidsramme: within a week of the index dental encounter
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Composite of provider actions reported by patient regarding delivery of brief interventions and/or referral to treatment.
These actions included that the provider 1) delivered a brief smoking intervention by discussing, a)developing a quit plan or b)setting a quit date or c)using medications to help patients quit or d)discussed strategies for quitting.
The provider made a 2) referral to a quitline; a)provided information about how to contact a tobacco quitline or b) arranged for the patient to be contacted by the tobacco quit line for smoking cessation.
The composite is satisfied if the patient reports that any of the intervention activities or referral was delivered by the provider.
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within a week of the index dental encounter
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Smokers With Initial Actions Related to Cessation
Tidsramme: within a week of index dental encounter
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Composite of patient-reported actions of smokers with initial actions related to cessation.
This composite is met if the patient reported that they contacted a smoking cessation quitline, set a quit date, developed a plan to quit, or is starting nicotine replacement or other medication to help quit within 1-7 days of their index dental visit.
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within a week of index dental encounter
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Percentage of Smokers With Long-term Actions Related to Cessation
Tidsramme: within six-months of index dental encounter
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Composite of patient-reported actions of smokers with long-term actions related to cessation.
This composite includes whether the patient reported that they quit smoking (stopped smoking for more than one day because they were trying to stop smoking), or reduced their smoking use (50% reduction in amount smoked at 6 months compared to baseline).
This composite is satisfied if the patient reports that they have done any of these actions within the 6 months +/- 1 week period between the index dental visit and the date of the second patient survey.
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within six-months of index dental encounter
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Heiko Spallek, DMD,PhD,MSBA, University of Sydney
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.
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 (Faktiske)
29. mars 2019
Primær fullføring (Faktiske)
30. desember 2020
Studiet fullført (Faktiske)
30. juni 2021
Datoer for studieregistrering
Først innsendt
31. august 2018
Først innsendt som oppfylte QC-kriteriene
31. august 2018
Først lagt ut (Faktiske)
4. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- A15-107
- U01DE026135 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Sharing of study outputs and resources is an essential element of this research.
To facilitate the conduct of future research, we will make available de-identified datasets and technical resources from the completed project in a manner consistent with human subject protection and HIPAA privacy regulations.
These resources will be subject to requirements imposed by the governing Institutional Review Board (IRB) and our organizational legal requirements.
IPD-delingstidsramme
Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
Tilgangskriterier for IPD-deling
Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician.
Study publications will note the method for requesting the study data and technical materials.
The study statistician will provide data and accompanying files in an archived zip format to requesters via email.
Data will not be stored in a public repository.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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