Clinical trial NCT03839043: Short Messaging Service Program to Help Quit Smoking During Perioperative Period.
Official title: Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Perioperative/Postoperative Complications
Tobacco Smoking
Keywords: Tobacco
Cigarettes
Surgery
Text Message
SMS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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").

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
timeFrame: 30 days Post Op
measure: 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
timeFrame: Cumulative from Day 1 to Day 30 Post Op
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David O Warner, MD
role: PRINCIPAL_INVESTIGATOR
References: