Clinical trial NCT06678672: Contingency Management for Veteran Smokers Undergoing Major Elective Surgery
Official title: Contingency Management for Veteran Smokers Undergoing Major Elective Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Substance Use Disorder (SUD)
Keywords: Tobacco
Contingency Management
Surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2024-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot randomized-controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Major elective surgery is common among Veterans and smoking is the most significant modifiable risk factor for perioperative morbidity and mortality. Major elective surgeries, including general, thoracic, vascular, urologic, spinal, orthopedic, and other surgeries, are common in the Veterans Affairs (VA) Healthcare System, with over 600,000 surgical procedures occurring annually across the VA. Reducing complications and death after major elective surgery is a top priority, both for Veterans and the general population. Smoking at the time of surgery is the single greatest risk factor for complications, reoperation, and death. The relative risk (RR) of death is 1.53 times higher in the 30 days after major surgery in smokers compared to non-smokers. Smoking before all types of surgeries is associated with postoperative pneumonia, prolonged intubation, myocardial infarction, stroke; infections, sepsis, and poor wound healing; and repeat procedures. Smoking at the time of surgery has additive risk of postoperative mortality when patients have other modifiable risk factors such as poor nutritional status, hyperglycemia, and alcohol use.

Contingency management (CM) is an efficacious, scalable behavioral intervention for smoking cessation in patients with tobacco use disorder (TUD). CM is a behavioral treatment that uses positive reinforcement to incentivize behavior change by delivering financial rewards (i.e., vouchers, cash equivalent) when the target behavior is achieved and biologically verified. It is feasible for Veterans with substance use disorder (SUD) and has been implemented widely across the VA. However, the CM protocol still needs to be tested out and evaluated to tailor for the clinical population.

The investigators will develop and test a tailored mobile smoking cessation contingency management (CM) protocol for Veterans undergoing major elective surgery. First, the investigators will adapt a CM protocol for delivery over 5 weeks using mobile CO monitoring in the perioperative period. To ensure acceptability, the investigators will consult with a Community Advisory Panel (CAP) of Veteran patient advocates; CM and surgery content experts; and VA policymakers on CM methods, timing, and delivery. The investigators will then conduct a pilot randomized-controlled trial (RCT) in which 36 Veteran smokers undergoing major elective surgery (general, spinal, thoracic, vascular, urological, gynecological, orthopedic, or gender-affirming) will be randomized to receive the 5-week perioperative mobile CM (n=18) or 5-week of treatment as usual (TAU, VA Tobacco Cessation Clinic and Quitline) (n=18). Participants in both conditions will receive pharmacotherapy. This study will demonstrate proof-of-principle of CM delivery perioperatively.

The aims of the study are as follows:

Aim 1: To develop a mobile CM smoking cessation protocol to be integrated into VA surgical settings.

Aim 2: To assess the feasibility of smoking cessation CM for VA surgery patients, measured by 1) Recruitment (ability to recruit ≥70% of the sample), 2) Engagement (≥50% of CM participants completing ≥25% of CM sessions and ≥25% of CO video uploads), and 3) Retention (measure completion in ≥60% of all participants at Week 5 (Study End)).

Aim 3: To compare CM with TAU on improving smoking cessation outcomes (quit attempts, cigarettes per day, and nicotine dependence severity) at Study End (Week 5).

Exploratory Aim: To measure cigarette abstinence in both conditions.

Eligibility criteria: Inclusion Criteria:

* English-speaking;
* Veteran enrolled in healthcare at SFVAHCS;
* Veteran scheduled for major elective surgery within the next 6 weeks (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 2 cigarettes per day (average), assessed by Timeline Followback (TLFB);
* Open to receiving smoking cessation interventions.

Exclusion Criteria:

Evaluated by investigative team medical record review and clinical assessment: - Psychotic disorders, bipolar disorder, neurocognitive disorder, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on M.I.N.I. Neuropsychiatric Inventory (M.I.N.I.) and/or medical record review;

* 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;
* Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55);
* A suicide attempt or suicidal ideation with intent in the 30 days before enrollment;
* Concurrent participation in another tobacco cessation trial.

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Up to approximately 20 months
measure: Feasibility - Engagement
timeFrame: Weeks 2-5
measure: Feasibility - Retention
timeFrame: Weeks 0-5 (Baseline - Week 5)
measure: Frequency of quit attempts
timeFrame: Weeks 0 - 5 (Baseline - Week 5)
measure: Amount of Cigarettes per day
timeFrame: Weeks 0 -5 (Baseline - Week 5)
measure: Nicotine dependence severity
timeFrame: Weeks 0 -5 (Baseline - Week 5)
Secondary outcomes:
measure: Cigarette Abstinence
timeFrame: Weeks 0 - 5 (Baseline - Week 5)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Health Care System
state: California
Study officials:
affiliation: San Francisco VA Health Care System
name: Ellen Herbst, MD
role: PRINCIPAL_INVESTIGATOR
References: