Perioperative Smoking Cessation Interventions
Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Purpose & Objective: Behavioral interventions in surgical patients are an opportunity to improve outcomes through decreased complications, with measurable economic impact. Smoking cessation is one of the most desirable long-term health behaviors for adults with potential substantial impact on postoperative complications
Study Activity & Population Group: The investigators propose a precommitment contractual agreement implementing behavioral economic principles at the preoperative appointment for active tobacco users undergoing an operation and assessing for ability to quit smoking with testing on the day of surgery, and the durability of cessation over the postoperative course as measured with urine nicotine testing at follow up appointments. The population of interest is adults who currently smoke tobacco or vaporized nicotine who are scheduled to undergo a major operation. The control group is standard of care; prescriptive advice to quit smoking. The intervention is contract agreement for preoperative cessation.
Data Analysis & Risk Issues: Following informed consent patients will be randomized to control or intervention groups, baseline urine nicotine tests will be performed in clinic. Urine nicotine testing will be performed on the day of enrollment, the day of their operation, and at their one-month follow up appointments. Thirty-day outcomes will be evaluated by retrospective chart review.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- active tobacco use
- preoperative appointment for an operation within 6 weeks
Exclusion Criteria:
- active enrollment in tobacco cessation program
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control: Prescriptive Advice
Amenable patients will be enrolled into the study, their intervention will be current standard of care smoking cessation counseling by their surgeon, they will undergo 3 urine tests and a chart review for outcomes.
|
|
|
Eksperimentell: Intervention1: Contract Agreement
Amenable patients will be enrolled into the study, their intervention will be a smoking cessation contract with their surgeon, they will undergo 3 urine tests and a chart review for outcomes.
|
Smoking Cessation Contract
|
|
Eksperimentell: Intervention2: Implementation Intentions
Amenable patients will be enrolled into the study, their intervention will be a worksheet to fill out with their smoking cessation implementation intentions that will be signed by patient and surgeon, they will undergo 3 urine tests and a chart review for outcomes.
|
Smoking Cessation Contract with worksheet for implementation intentions
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking Cessation
Tidsramme: day of surgery
|
Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
|
day of surgery
|
|
Smoking Cessation
Tidsramme: day of first postoperative appointment
|
Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
|
day of first postoperative appointment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Complications
Tidsramme: 30 days postoperatively
|
National Surgical Quality Improvement Project postoperative complications: based on patient chart review
|
30 days postoperatively
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christopher R Mantyh, MD, DUKE DEPARTMENT OF SURGERY
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 (Faktiske)
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
- Pro00076125
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Intervention1: Contract Agreement
-
Cardenal Herrera UniversityFullførtHamstring-fleksibilitetSpania
-
Riphah International UniversityFullførtMuskelstrammingPakistan
-
Yonsei UniversityUkjent
-
University of FloridaFullført
-
Washington University School of MedicineNational Institute on Drug Abuse (NIDA)FullførtSeksuelt overførbare sykdommer | HIV | Stoffmisbruk