A bstinence R einforcement T herapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention

Abstract

Introduction Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. Objective The primary goal of the current study is to evaluate the effectiveness of an intervention that combines 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 rural Veteran smokers. Specifically, Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or a control condition (i.e., TC and NRT alone) that will provide controls for therapist, medication, time and attention effects. Methods Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N = 310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. Discussion This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective.

Enrollment and Retention of Men and Women in Health Services Research and Development Trials

“…These eight trials started recruitment between 2011 and 2014. Of these trials, one included dyads of patients and caregivers (Van Houtven et al, 2014), four targeted cardiovascular disease risk factors including obesity and hypertension (Jackson et al, 2016;Oddone et al, 2017;Voils et al, 2014;Voils et al, 2016;Zullig et al, 2014;Zullig et al, 2015), one addressed smoking cessation (Wilson et al, 2016), one addressed emergency department follow-up (Hastings et al, 2014), and one addressed osteoarthritis of the knee and hip (Allen et al, 2012; Table 1). The mean participant age was 57.7 years for women and 65.9 years for men.…”

“…In doing so, we found that the proportion of women ranged from 5.1% to 13.3% at the initial data pull, 4.4%-11.7% for mailed recruitment letters, 4.4%-19.2% during attempted to contact for screening, 3.3%-22.0% of those consented, and 3.3%-22.2% of those participants who completed the final outcome assessment. Five studies consented more than 10% women (Hastings et al, 2014;Oddone et al, 2017;Voils et al, 2014;Wilson et al, 2016;Zullig et al, 2014), and all but one of those targeted conditions that are not inherently tied to the patient's age (e.g., smoking, obesity, inactivity, or emergency department use). The one study that did target age-related conditions, specifically hypertension and hyperlipidemia, also aimed to increase recruitment of women (Zullig et al, 2014).…”

“…The one study that did target age-related conditions, specifically hypertension and hyperlipidemia, also aimed to increase recruitment of women (Zullig et al, 2014). Of the five studies with available numbers for participants completing screening and refusals, the proportion of women who refused participation was lower in three studies (Hastings et al, 2014;Oddone et al, 2017;Wilson et al, 2016), similar in one (Allen et al, 2012), and greater in one (Van Houtven et al, 2014). Of those who consented to study participation, 63.2%-100% of women completed the primary outcome assessment compared with 61.4%-99.6% of men; these proportions were generally similar within specific studies (data not shown).…”

“…All but two studies had women-only interventionists (Wilson et al, 2016;Zullig et al, 2014). Two studies collected primary outcomes via administrative data (Hastings et al, 2014;Van Houtven et al, 2014), five required inperson visits (Allen et al, 2012;Jackson et al, 2016;Oddone et al, 2017;Voils et al, 2014;Zullig et al, 2014), and one used phone and mail methods (Wilson et al, 2016). Across all studies, there were three to five study outcome assessments, but two studies used remote or phone assessments only (Hastings et al, 2014;Wilson et al, 2016).…”

“…Presence and type of telehealth required for study Table 2 Study Characteristics PRIMO (Allen et al, 2012) CITIES (Melnyk et al, 2013;Zullig et al, 2014) MAINTAIN (Voils et al, 2014) TDM (Jackson et al, 2016) DISPO-ED (Hastings et al, 2014) ART (Wilson et al, 2016) ACTIVATE ( women (e.g., high burden of in-person visits, ineligibility criteria related to conditions highly prevalent among women). In addition, the proportion of women generally increased from the initial data pull stage to consent, and women completed final outcomes assessments in similar proportions to men.…”