Contingency Management for Veteran Smokers Undergoing Major Elective Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
The goal of this study is to design and test the first mobile contingency management (CM) smoking cessation intervention for military Veterans undergoing major elective surgery. Smoking is the leading risk factor for postoperative complications and is associated with longer hospital stays, reoperations, and 30-day mortality. Smoking rates among patients undergoing major elective surgery are high, 22.3-43.0%. It is imperative to identify efficacious, strategically timed smoking cessation interventions for surgery patients.
CM incentivizes smoking cessation through positive reinforcement (rewards) when bioverified abstinence is achieved. To ensure feasibility, CM must be tailored to the clinical context. CM for smoking cessation has never been delivered before and after major surgery, nor has mobile CM bioverification been trialed perioperatively. The investigators will develop and test a tailored mobile smoking cessation CM protocol for Veterans undergoing major elective surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English-speaking;
Veteran enrolled in healthcare at SFVAHCS;
Veteran scheduled for major elective surgery within the next 6 months (including but not limited to: general, spinal, thoracic, vascular, urological, gynecological, orthopedic, gender affirming). Veterans, who are followed at SFVAHCS by Primary Care and are referred to outside institutions for major surgery (e.g., gynecological or gender-affirming surgeries) are also eligible to participate;
Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB);
Disqualifiers
Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score ≥ 8;
Enrollment in end of life/ palliative care;
Surgery with a clinical indication for cancer;
Unable to meet time commitment;
Trial design
Design model
Parallel
Treatments tested in this trial
Contingency Management (CM)
BehavioralThe participants will receive and be trained to use a CO monitor and iCO app to upload videos to verify smoking abstinence at a minimum of once per day, 5 times per week, over 5 weeks. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through remote CO monitoring. They will receive clinician feedback at the time of each CO reading, following the established VA CM protocol developed in the earlier phase of the project. Each CO reading during the weeks 2-5 will also be accompanied with a brief (5-minute) telephone or video feedback CM counseling session from the study clinician.
Treatment as Usual (TAU)
BehavioralParticipants assigned to TAU will receive usual care at San Francisco VA Health Care System (SFVAHCS), i.e., referral to Tobacco Cessation Clinic and the VA Telequit Quitline. The SFVAHCS Tobacco Cessation Clinic is a consult service that calls patients proactively 3 times to offer 1:1 behavioral counseling for smoking cessation. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for up to 5 sessions per NCI Quitline guidelines. The smoker initiates the first call, and subsequent calls will be proactively made by Quitline staff.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Contingency Management (CM)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Recruitment
Ability to recruit ≥70% of the target sample within the study timeline, i.e., at least 25 of 36 participants are enrolled.
Time frame
Up to approximately 20 months2
Feasibility - Engagement
It will be measured by the cutting points of ≥50% of participants attending ≥25% CM sessions and ≥25% CO video uploads during Weeks 2-5 in the CM intervention group.
Time frame
Weeks 2-53
Feasibility - Retention
It will be measured by a cutting point of ≥60% of enrolled participants completing self-report measures, staff measures, and bioverification over 5 weeks of the study.
Time frame
Weeks 0-5 (Baseline - Week 5)4
Frequency of quit attempts
Quite attempts (a period of intentionally not smoking for ≥ 24 hours) will be assessed by self-report (Nicotine and Tobacco Use Survey) and confirmed with Timeline Follow-Back (TLFB, past 30 days). Nicotine and Tobacco Use Survey was developed by our team and it will assess age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for ≥ 24 hours), duration of cessation (if any), and presence of other tobacco users in the home. At Week 5, the survey will also inquire about the frequency and duration of quit attempts in the past 30 days. TLFB uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Time frame
Weeks 0 - 6 (Baseline - Follow-up)Secondary outcomes
1
Cigarette Abstinence
A 7-day point prevalence cigarette abstinence will be defined as 1) no smoking 7 days prior (via TLFB), and 2) CO levels \< 6 ppm. For individuals with CO levels \> 6 ppm, who report smoking cannabis on TLFB and not receiving Nicotine Replacement Therapy (NRT), salivary cotinine \<10 nanograms/ milliliter (ng/ml) will be used.
Time frame
Weeks 1-6 (Week 1 to Follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Tobacco Related Disease Research Program
Collaborator
Source ClinicalTrials.gov