Perioperative Smoking Cessation Interventions
Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- active tobacco use
- preoperative appointment for an operation within 6 weeks
Exclusion Criteria:
- active enrollment in tobacco cessation program
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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.
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Experimentell: 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.
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Smoking Cessation Contract
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Experimentell: 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.
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Smoking Cessation Contract with worksheet for implementation intentions
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Smoking Cessation
Tidsram: day of surgery
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Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
|
day of surgery
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Smoking Cessation
Tidsram: day of first postoperative appointment
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Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
|
day of first postoperative appointment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Complications
Tidsram: 30 days postoperatively
|
National Surgical Quality Improvement Project postoperative complications: based on patient chart review
|
30 days postoperatively
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christopher R Mantyh, MD, DUKE DEPARTMENT OF SURGERY
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00076125
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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-
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