Perioperative/Postoperative Complications, Tobacco Smoking, Tobacco Use Cessation
Conditions
Keywords
Tobacco, Cigarettes, Surgery, Text Message, SMS
Brief summary
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.
Detailed description
The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery (quit for a bit) can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence (quit for good).
Interventions
BEHAVIORALBrief behavioral intervention
Quit for a bit- \*advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence\* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems\*reduction of these risks if able to quit for a bit\*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. Quit for good- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.
OTHERSMS Program
Quit for a bit- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days.Quit for good- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.
Intervention model description
Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a quit for a bit or a quit for good intervention. Both stratums employ a Short Message Service (SMS or text) to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The quit for a bit intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment * Willingness to either quit for a bit or quit for good in the perioperative period, and; * Owning a device with access to SMS with an unlimited text plan
Exclusion criteria
* Surgery on the day of POE evaluation * Any active psychiatric condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30 | 30 days Post Op | Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days. |
| The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of keywords sent via SMS by the subjects | Cumulative from Day 1 to Day 30 Post Op | Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service |
Countries
United States
Outcome results
None listed