Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Unfortunately, smoking cessation treatment including smoking cessation aids such as nicotine replacement therapy are greatly underutilized. There is a special need to develop effective interventions that target rural Veterans. Veterans living in rural areas are at particular high risk for smoking related morbidity and mortality. Rural Veterans are significantly less likely to access intensive clinic-based smoking cessation care. Efforts are needed to expand the reach of smoking cessation treatment options beyond the clinic. It has been suggested that there is a need of more innovative and intensive approaches to smoking cessation in order to improve quit rates, particularly in settings where treatment options are limited such as rural areas. The use of intensive behavioral therapies, such as contingency management (CM), may be a useful component to increase the efficacy of smoking cessation interventions. CM has shown efficacy for reducing smoking in several difficult-to-treat populations. Recent developments in mobile health (mHealth) has made CM more portable and feasible.
The primary goal of this study was to evaluate the effectiveness of an intervention that combined evidenced based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a contact control intervention in a randomized controlled trial among Veteran smokers. Veterans were randomized to receive Abstinence Reinforcement Therapy (ART) which combined five-sessions of proactive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or to a control condition which included the same proactive counseling and tele-medicine clinic as ART but did not include mCM.
Smokers were identified using VHA electronic medical records, sent an introductory opt-out letter, and proactively recruited by telephone. Inclusion criteria included enrollment at the Durham VA Health Care System and willingness to make a quit attempt in the next 30 days. Veterans who had no access to telephone, severely impaired hearing or speech, active psychosis, or current hospitalization were excluded. Participants (N=310) were randomized to either ART or to a control condition that included the same five-sessions of proactive telephone counseling and tele-medicine clinic for NRT. Randomization was stratified by distance to the Durham VAMC or closest VA clinic that provided smoking cessation care (<15 miles, 15-49 miles, > 50 miles) and presence of psychiatric condition (defined as screening positive for PTSD, depression, or alcohol abuse). Participating Veterans were surveyed at 3-months, 6-months, and 12-months post-randomization. The primary outcomes included self-reported and biochemically validated measures of smoking abstinence. Cost analyses were conducted from the perspective of the VA as payer and provider.
Participants randomized to ART were mailed study equipment including a carbon monoxide monitor and mobile device preloaded with a mCM application. In order to verify smoking abstinence, participants used the mobile device and app to video themselves blowing into the CO monitor. The app captured and encrypted the video and transferred it to a secure server where it was used to verify abstinence. During four weeks of active CM, reinforcement of smoking abstinence occurred twice daily contingent upon an abstinence criterion of CO < 6 ppm. Patients randomized to ART could receive up to $300 in incentives for uploading mCM videos and complete abstinence (participants could earn up to $235 during the 4 weeks of active mCM). Escalating and reset contingencies were employed.
The sample (N=310) had a mean age of 56.6 years (SD=10.8) with a mean score of 4.8 (SD=1.92) on the Fagerstr m Test for Nicotine Dependence indicating moderate nicotine dependence; 57% identified as African-American; 43% were married; 11% were women. A large proportion of the sample screened positive for depression (52%), PTSD (31%), or hazardous alcohol use (32%). Intervention reach did not differ between groups. The majority (93%) of both groups received 1 or more therapy calls. The ART group completed an average of 3.5 treatment sessions (SD=1.86); the Control arm completed an average of 3.4 sessions (SD=1.96).
Analyses of the smoking cessation outcomes were modeled based on the complete case analysis (i.e., missing = smoking) and were adjusted for stratification variables which included presence of a psychiatric condition and distance to the VA. At 3-months post-randomization, there were no significant differences in smoking cessation by arm in 7-day self-reported abstinence (38% ART; 37% Control). Similarly, no differences were found at the 6-month (28.8% ART; 33.7% Control) or 12-month follow-ups (26.2% ART; 25.2% control) in 7-day self-reported abstinence. Models examining prolonged abstinence found no differences between arms at 6-months [ART: 24.2% (95% CI 18.1%-31.6%) vs. Control: 25.9% (95% CI 19.6%-33.3%)] or the 12-month follow-up [ART: 20.4% (95% CI 14.7%-27.5%) vs. Control: 20.0% (95% CI 14.4%-27.0%)]. Participants reporting 7-day abstinence were asked to provide a saliva sample by mail. At the long-term 12-month follow-up 78% of those reporting abstinence returned a saliva sample. Of these, 9% reported current NRT use thus making them ineligible for cotinine testing. Among those eligible for cotinine testing, there was good concordance between self-report and bio-verified results (only 5% of cases provided samples with cotinine results that indicated smoking). At the 12-month follow-up, 18.6% of veterans randomized to ART were bio-verified abstinent compared to 14.9% of those randomized to the telehealth control comparison condition.
ART was associated with significantly higher direct costs ($604 per patient) than the control arm ($164 per patient) which was primarily attributable to costs associated with providing smart-phones and CO monitors to participants for use during the intervention. The average amount earned for abstinence incentives was $113.
Quit rates, including 12-month prolonged abstinence and 12-month cotinine verified abstinence, were high in both arms indicating support for a strategy that includes both proactive recruitment and proactive counseling paired with a tele-medicine clinic for access to NRT. Further, this project demonstrates that mobile monitoring and reinforcement of smoking abstinence in Veterans is feasible. The addition of incentives (up to $235 for complete abstinence), however, was not more effective at producing short or long-term abstinence than proactive counseling and NRT alone.
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