- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02721082
Changing the Default for Tobacco Treatment
Studieoversikt
Status
Forhold
Detaljert beskrivelse
In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.
For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.
This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Speak English or Spanish
- Have access to a telephone or mobile phone
- Not be currently pregnant or breast feeding
- Have no significant co-morbidity that precludes participation
- Current daily smoker
- Not in treatment for tobacco dependence
- Reside in Kansas or Missouri
Exclusion Criteria:
- Admission greater than 3 days
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out".
Participant will receive a Opt Out treatment program.
Participants will receive counseling and nicotine replacement therapy.
|
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Andre navn:
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Andre navn:
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Aktiv komparator: Opt In
Traditional approach to tobacco treatment program.
Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
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Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Andre navn:
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Andre navn:
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking.
For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
7-day Point-prevalence Abstinence
Tidsramme: Month 1
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7-day, self-reported and verified cigarette abstinence.
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Month 1
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Treatment Engagement
Tidsramme: Month 1
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Percentages of participants who use cessation medications and participate in counseling post discharge
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Month 1
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Default-theory Based Measures
Tidsramme: Month 1
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We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.
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Month 1
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7-day Point-prevalence Abstinence
Tidsramme: Month 6
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7-day, self-reported and verified cigarette abstinence.
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Month 6
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cost-effectiveness
Tidsramme: Month 6
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Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER).
The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms.
ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies.
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Month 6
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kimber Richter, PhD, University of Kansas Medical Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441.
- Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00001774
- R01HL131512 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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