None listed
Conditions
Brief summary
Over 20,000 Australians die each year from smoking. Such deaths are cardiovascular related in almost 40%. Even having a few cigarettes a day doubles risks of a heart attack. Quitting sharply reduces risks within a year or two, and is the best thing you can do for your heart. Each year, large numbers of smokers have planned (elective) surgery for both vascular and non-vascular reasons. Promising evidence shows that offers of quit-help are particularly effective at this time in encouraging permanent quitting. This will be the first study to evaluate the effect of a tailored quit intervention for all smokers (light and heavy) having elective surgery. The intervention will be offered weeks/months before surgery when the smoker is first put on the waiting list, as this gives more time for quitting and gets hearts and lungs in better shape for surgery. The intervention will be fast-acting Nicotine Replacement Therapy (NRT) lozengers, plus patches (for heavier smokers), and the tailored supply will be posted to acceptors of the offer. The telephone Quitline will provide extra support while quitting. According to our existing data, relapse to daily smoking after hospitalisation for surgery occurs in 50% of newly abstinent smokers. This will also be the first study to evaluate a relapse prevention strategy for new quitters after having surgery. The relapse kit “Open in case of smoking emergency” will contain advice, phone numbers and fast-acting NRT. The use and effectiveness of the kit in protecting new abstinence will be studied 3-months after surgery. This study builds on previous work by us that mailed NRT before planned surgery is feasible and increases quitting. By including all smokers, tailored NRT dosing, and a relapse kit, we hope to offer an effective low-cost intervention that any health service could adopt for the many smokers who have surgery. If more Australians give up smoking for good, heart attacks, blocked blood vessels and strokes will be prevented.
Interventions
Randomised controlled trial of uptake, use and smoking cessation outcomes after an offer of smoking cessation help in adult elective surgery patients who smoke, compared to standard care. Intervention group smokers receive an invitation, pre-surgery, when name is placed on the elective-surgery wait-list for free nicotine replacement therapy (NRT) mailed to their home, printed quit information and enrollment in Quitline call-back service for telephone support. The intended use is for assistance
Randomised controlled trial of uptake, use and smoking cessation outcomes after an offer of smoking cessation help in adult elective surgery patients who smoke, compared to standard care. Intervention group smokers receive an invitation, pre-surgery, when name is placed on the elective-surgery wait-list for free nicotine replacement therapy (NRT) mailed to their home, printed quit information and enrollment in Quitline call-back service for telephone support. The intended use is for assistance with pre-surgical quitting. The dose of NRT will vary according to nicotine dependence (a) Highly dependent (smokes >15/day): 5-weeks of NRT patches, reducing dose regimen as follows: Size, 21-mg/worn for 24-hrs, changed daily, duration of use=3 weeks, then size 14-mg/worn for 24hrs, changed daily, duration of use=1 week then size 7-mg/worn for 24hrs, changed daily, duration of use=1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (b) Moderately dependent (10-15/day): 3-weeks of patches, size 14-mg/worn for 24/hrs, changed daily, duration=2 weeks, followed by size 7-mg/worn for 24hrs, changed daily, duration =1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (c)Light/intermittent/social (<10/day): No patches, 2mg nicotine lozengers, to be used if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. Participants in intervention group may request the NRT products at any time prior to their operation date, including an additional course of treatment if the initial products posted did not achieve smoking abstinence prior to surgery. The additional printed information sent to smokers in the intervention group prior to surgery is an existing Quitline resource, https://www.quit.org.au/documents/231/AQ710_Smoking_and_Surgery_DL_update_v5.pdf Participants quit by surgery for >24 hours will be offered a "Relapse Prevention Kit" on day of operation for use after hospital discharge. This consists of further 2mg NRT lozengers, to be used if cravings occur after hospital discharge, and printed relapse prevention advice. This printed advice will be existing Quitline resources: https://www.quit.org.au/131/download https://www.quit.org.au/385/download
Sponsors
Dr Ashley Webb
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any smoker Having elective surgery Available for data collection on day of surgery
Exclusion criteria
1. Unable to understand study requirements 2. Age<18 3. Weight <45 kg (from preop HQ) 4.Pregnancy or breastfeeding 5. Contraindication to nicotine patch. eg allergy 6. Already on stop-smoking medication 7. No phone 8. Emergency surgery 9. Not available for data collection on day of surgery.
Outcome results
None listed