Proactive Tobacco Treatment for Smokers Using Veterans Administration Mental Health Clinics

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1 RESEARCH ARTICLE Proactive Tobacco Treatment for Smokers Using Veterans Administration Mental Health Clinics Erin S. Rogers, DrPH, MPH, 1,2 Steven S. Fu, MD, MSCE, 3,4 Paul Krebs, PhD, 1,2 Siamak Noorbaloochi, PhD, 3 Sean M. Nugent, BA, 3 Amy Gravely, MA, 3 Scott E. Sherman, MD, MPH 1,2 This activity is available for CME credit. See page A3 for information. Introduction: Veterans with a mental health diagnosis have high rates of tobacco use but encounter low rates of treatment from providers. This study tested whether a proactive tobacco treatment approach increases treatment engagement and abstinence rates in Department of Veterans Affairs mental health patients. Study design: RCT. Setting/participants: The study was performed from 2013 to 2017 and analyses were conducted in Investigators used the electronic medical record at four Veterans Administration facilities to identify patients documented as current smokers and who had a mental health clinic visit in the past 12 months. Intervention: Patients were mailed an introductory letter and baseline survey. Survey respondents were enrolled and randomized to intervention (n¼969) or control (n¼969). Control participants received a list of usual Veterans Administration smoking services. Intervention participants received a motivational outreach call, multisession telephone counseling, and assistance with obtaining nicotine replacement therapy. Main outcome measures: Participants completed surveys at baseline, 6 months, and 12 months after randomization. The primary outcome was self-reported 7-day abstinence from cigarettes at 12- month follow-up. Secondary outcomes included use of cessation treatment, self-reported 7-day abstinence at 6-month follow-up, and 6-month prolonged abstinence at 12-month follow-up. Results: At 12 months, intervention participants were more likely to report using telephone counseling (19% vs 3%, OR¼7.34, 95% CI¼4.59, 11.74), nicotine replacement therapy (47% vs 35%, OR¼1.63, 95% CI¼1.31, 2.03), or both counseling and nicotine replacement therapy (16% vs 2%, OR¼11.93, 95% CI¼6.34, 22.47). Intervention participants were more likely to report 7-day abstinence (19% vs 14%, OR¼1.50, 95% CI¼1.12, 2.01) and prolonged 6-month abstinence (16% vs 9%, OR¼1.87, 95% CI¼1.34, 2.61). After adjusting for non-ignorable missingness at follow-up, the intervention effects on 7-day and prolonged abstinence remained significant (po0.05). Conclusions: Proactive outreach was more effective than usual Veterans Administration care at increasing treatment engagement and long-term abstinence in mental health patients. Trial registration: This study is registered at NCT Am J Prev Med 2018;54(5): Published by Elsevier Inc. on behalf of American Journal of Preventive Medicine From the 1 VA New York Harbor Healthcare System, New York, New York; 2 Department of Population Health, New York University School of Medicine, New York, New York; 3 VA HSR&D Center for Chronic Disease Outcomes Research (CCDOR), Minneapolis VA Health Care System, Minneapolis, Minnesota; and 4 Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota Address correspondence: Erin S. Rogers, DrPH, MPH, New York University School of Medicine, 227 East 30th Street, New York NY erin.rogers@nyumc.org /$ Am J Prev Med 2018;54(5): Published by Elsevier Inc. on behalf of American Journal of Preventive Medicine

2 INTRODUCTION Smoking remains the leading preventable cause of death in the U.S. 1 People with a mental health diagnosis have particularly high rates of tobacco use and consume 40% of cigarettes sold in the U.S. annually. 2 Most mental health patients who smoke are interested in quitting, but face a number of unique barriers that increase the difficulty of quitting namely higher nicotine dependency, use of smoking for symptom management, higher levels of stress, and greater susceptibility to relapse. 3 8 Previous research has found that that intensive, multisession telephone counseling combined with cessation medications improves quit rates in smokers with mental health conditions. 9 However, even when evidence-based treatments exist, mental health patients face barriers to accessing treatment including limited support and tobacco treatment from providers. 8,10 13 In the U.S., outpatient psychiatrists have been screening their patients for smoking at declining rates, counsel or refer only about 20% of patients they know to be smokers to treatment, and provide cessation medications to only 1% of smokers. 12 In a prior study that implemented a telephone care coordination program for smokers using Veterans Administration (VA) mental health services, 9 mental health clinic providers could refer their patients to the program using an easy consult in the electronic medical record (EMR). Despite this easy referral mechanism, most providers made no referrals, and among those who did, 45% referred only one patient. Prior research has found that providing tobacco treatment proactively (i.e., without relying on provider referral) increases population-level abstinence in primary care and socioeconomically disadvantaged populations. 14,15 There have been no previous trials testing this approach in a mental health population. The current study tests the reach and effectiveness of a proactive, intensive tobacco intervention for smokers using VA mental health services. 16 It is hypothesized that the proactive intervention will increase the proportion of smokers who are abstinent at 12-month follow-up compared with usual VA care. METHODS Study Population The study was conducted from 2013 to The study used a two-group RCT design at four VA facilities: (1) the VA New York Harbor Healthcare System in New York City; (2) the VA Minneapolis Healthcare System in Minneapolis, Minnesota; (3) the Michael E. DeBakey VA Medical Center in Houston, Texas; and (4) the James A. Haley Veterans Hospital in Tampa, Florida. The research activities were approved by the VA Central IRB Rogers et al / Am J Prev Med 2018;54(5): (protocol 12-42). The study was registered at clinicaltrials.gov (NCT ). Patients were eligible for inclusion if they (1) had smoked even a cigarette puff in the past 30 days and (2) had a VA mental health clinic visit in past 12 months. Exclusion criteria included (1) ICD-9 diagnosis of dementia (determined using EMR data); (2) did not speak English; and (3) did not have a telephone number and mailing address. Potential participants were identified using data contained in the VA s EMR. Step 1 was selecting current smokers. Current smokers were identified using tobacco use clinical reminder codes indicating a positive tobacco use screening in the previous 6 months. Patients were excluded if they had an ICD-9 diagnosis of dementia (i.e., 290.XX or 331.XX). Step 2 was identifying mental health patients. Within the list of eligible smokers, programmers identified patients treated in the previous 12 months in a VA mental health clinic using clinic stop codes. Step 3 was selecting the recruitment sample. From the group of current smokers with a recent mental health visit, programmers selected all women and a random sample of men to total 1,600 potential participants from each site (n¼6,400) as the initial recruitment pool. Each month, the list of patients was updated until the study reached its target sample size of 1,940 participants. Each patient on the recruitment list was mailed a letter from the Chief of Staff, facility Behavioral Health Coordinator or other facility leader stating the patients would be contacted about a research study with the goal of helping Veterans who use mental health services stop smoking. The letter included information on how to stop receiving further study materials or if the patient had been erroneously contacted (e.g., not a current smoker, had not used mental health services). One week later, study staff sent an information packet to patients, including a cover letter, a sheet of study Frequently Asked Questions that contained all elements of informed consent, and a baseline survey. The cover letter and Frequently Asked Questions sheet informed patients that they would receive $10 for returning the survey. The survey asked patients if they had smoked a cigarette in the prior 30 days. Patients who returned a baseline survey and had smoked in the past 30 days were enrolled in the study. When study staff received a baseline survey, the project director entered the patient s status into a tracking system that randomized participants 1:1, stratified by site, using a randomization list created by the study s statistician. Research assistants conducting patient follow-up surveys remained blind to randomization. Participants randomized to the control group were mailed a list of local VA and non-va smoking-cessation services. In addition, patients in the control group may have received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy was available at all sites in the form of nicotine replacement therapy (NRT; patches, gum, and lozenges), bupropion, and varenicline. Within 1 week of randomization, a study counselor began outreach calls to participants in the intervention group to offer tobacco treatment. The purpose of the outreach call was to (1) deliver motivational enhancement to quit smoking; (2) promote self-efficacy in quitting; and (3) encourage participation in smoking-cessation treatment. Counselors made up to six attempts over 1 month to reach participants. Participants who scheduled a counseling session received a course of telephone counseling that was previously found to be more effective with VA mental health patients than state quitline counseling. 9,17 The protocol May 2018

3 622 was designed to help patients develop an individualized quit plan and to provide support during the execution of the plan. A prior study 9 testing this protocol that compared transferring VA mental health patients to their state quitline for counseling found that participants in the intensive counseling intervention were more likely to report receiving assistance with developing a quit plan; receiving follow-up calls after quitting; and receiving assistance with motivation, confidence, smoking triggers, coping with urges, and mental health symptoms. Intensive counseling participants were more satisfied with treatment and more likely to find the counseling useful than participants transferred to their quitline. The protocol is characterized by the following: Multiple sessions: Participants could receive up to 12 counseling calls (eight calls over 2 months to help participants make a quit attempt plus four monthly maintenance calls). Motivational enhancement: Guided by a motivational interviewing approach, counselors included motivational enhancement in the pre-quit calls and as needed during later calls to increase patient motivation to quit and reduce relapse. Relapse-sensitive scheduling: The protocol encouraged participants to receive four calls to plan a quit date, three calls in the first 2 weeks after their quit date when relapse risk is highest, followed by another call 4 weeks after their quit date. Participants received monthly maintenance calls for 4 months to work through any quitting slips or barriers. Counselors could modify this schedule based on patient s quit progress. Problem-solving therapy: The quit plan development process used a problem-solving therapy approach, which helped participants identify and solve quitting challenges. Stress reduction: The protocol included stress reduction techniques, such as relaxation and mindfulness exercises, and stress reduction self-help materials designed for the study. For intervention participants interested in NRT, counselors placed an alert in the EMR system for their facility s smokingcessation program or the participant s regular primary care provider indicating that the participant expressed interest in receiving NRT. The alert contained prescribing information from the U.S. Public Health Services tobacco treatment guidelines. 18 In recognizing that a patient s mental health providers are an important source of support, counselors engaged intervention patients primary mental health providers into the treatment process by alerting the providers of their patients counseling progress via EMR progress notes. The study s three full-time employment equivalent counselors had master s degrees in a counseling field and underwent 4 hours of motivational interviewing training with their clinical supervisor plus hours of training on the study s clinical protocols with the study s project director and clinical supervisor. This training included an overview of evidence-based tobacco treatments for general and mental health populations and an overview of the study s manualized counseling protocol. This training included counseling role-plays with each other and their supervisor. To ensure counseling standardization and fidelity during the study, the counselors completed clinical documentation using a template that allowed them to log calls completed, call length, and the protocol objectives covered during each call. The counselors also attended weekly group supervision meetings, during which time active cases were discussed. Rogers et al / Am J Prev Med 2018;54(5): Measures Participants were surveyed by mail before randomization. The baseline survey assessed sociodemographics (gender, age, income, race, ethnicity, education, marital status, employment); smoking habits and history (cigarettes smoked per day, current and past electronic cigarette use, age started smoking, past quit attempts) 19 ; cessation treatments offered by providers in the prior year; nicotine dependence (minutes until first cigarette after waking) 20 ; and quitting motivation and self-efficacy (1 10 scales); and administered the Kessler-6 scale to assess psychological distress (possible score range, 6 30) 21 and the eight-item Patient Health Questionnaire to assess depressive symptoms (possible score range, 0 24). 22 Participants were surveyed by phone at 6 and 12 months after randomization. If participants did not respond to telephone survey outreach, the study sent them a mailed survey with a selfaddressed, stamped return envelope. All baseline measures were assessed again at follow-up, except for sociodemographics. Followup surveys also assessed cessation outcomes recommended for tobacco cessation clinical trials. 23 These included smoking abstinence (7-day point prevalence and prolonged 6-month abstinence); quit attempts; cigarettes smoked per day; and use (yes or no) of cessation pharmacotherapy and non-pharmacological cessation treatments since enrolling. Participants received a $10 check for completing each survey. Self-reported abstinence was verified by assays of cotinine. Participants were eligible for abstinence verification if they reported 7-day abstinence from any nicotine (cigarettes, other tobacco, e-cigarettes, NRT) at each follow-up timepoint. Sample collection was conducted by mail. A research assistant sent eligible participants a Salimetrics SalivaBio Oral Swab collection kit with sampling instructions and a postage-paid return envelope. Research assistants sent two more kits and made five reminder phone calls to encourage participants to return the kit within 30 days of completing the follow-up survey. Participants received a $25 check for returning a saliva sample. Programmers used the VA EMR to obtain administrative data at baseline on all patients in the full recruitment cohort and at 12 months on all enrolled participants. Data included sociodemographics, cessation prescriptions in the prior 12 months, healthcare visits in the prior 12 months, and diagnoses in the prior 12 months. Each patient s primary mental health diagnosis was coded as the most frequently occurring diagnosis coded during mental health clinic encounters during the year prior to randomization. The primary outcome was self-reported 7-day abstinence from cigarettes at 12-month follow-up. Secondary outcomes included use of cessation treatment, self-reported 7-day abstinence at 6- month follow-up, and 6-month prolonged abstinence at 6- and 12- month follow-up. Statistical Analysis Analyses were conducted in At 6 months, complete followup survey data were obtained from 75% of intervention and 79% of control participants (Figure 1). At 12 months, complete follow-up survey data were obtained from 64% of intervention and 71% of control participants. Observed abstinence rates, CIs and ORs were calculated, as well as use of treatment rates and counseling call counts for participants in the intervention arm. Bivariate logistic regression was used to compare abstinence rates and use of

4 Figure 1. Study recruitment, intervention delivery, and retention. treatment rates between study arms. In accordance with the study protocol that used random group assignment and because covariates appeared to be balanced between groups (Table 1), covariates were not added into the logistic regression models. Because bias can occur when assuming that survey nonresponders are smokers 24 or when missing follow-up data is because of the value of the response variable 25 (e.g., abstinence), the study also implemented the methods proposed by Ibrahim 26 to handle missing outcome data for abstinence outcomes. This method allows the probability that an outcome is missing to depend on covariates and the response variable (i.e., missing data depends on the outcome and is non-ignorable). Covariates were obtained through baseline survey and administrative data collected on all participants. The covariates included in the non-ignorable missingness models were carefully considered by the statistical team and balanced with what was possible given model complexity. Maximum likelihood estimates were obtained via the expectation maximization algorithm by maximizing the expected log-likelihood where the expectation is taken over the missing data given the observed data. Multiple iterations were run until participant weights were calculated (if the response data were observed, the weight¼1). The weights were then used in the original logistic regression models. RESULTS Figure 1 displays the results of the study s proactive recruitment. Of the 14,440 patients to whom an outreach packet was mailed, 2,395 (17%) returned a survey. Two Rogers et al / Am J Prev Med 2018;54(5): percent (257) of mailings were undeliverable (bad address); 87 patients (1%) contacted the study to request no further contact; and 13 patients (0.1%) were reported by friends or family to be deceased. Study staff had no information about the nonresponse of 81% of patients to whom a packet was mailed. Of the patients who returned a survey, 434 had not smoked in the prior 30 days and 23 returned the survey after enrollment was complete. The final sample size was 1,938 participants recruited in 15 months. Table 1 displays participant characteristics. Participants were predominantly middle-aged white or black men who were retired or unable to work and had an income $40,000 per year. Participants were smoking on average three quarters of a pack per day, and about 15% had used electronic cigarettes in the past 7 days. Very few participants (o5%) had used a telephone program to try to quit in the prior year. Substance use was the most common primary psychiatric diagnosis in the sample, and participants were regularly engaged in primary and mental health care. Participants had, on average, severe levels of psychological distress (mean, 14 [SD¼6] on the Kessler-6) and mild/moderate average depressive symptoms (mean, 9 [SD¼7] on the 8-item Patient Health Questionnaire). Appendix Table 1 (available online) displays the characteristics of patients who did and did not enroll in the study. Compared with patients who did not enroll in the study, those who enrolled were older, less likely to be married, more likely to be black and live in an urban setting, more likely to have a substance use disorder, and had more primary care and mental health visits in the previous year (po0.05). However, although statistically significant, the absolute group differences were very small. Table 2 displays self-reported use of cessation treatment on the 12-month follow-up survey. Intervention participants were more likely than control participants to use telephone counseling (19% vs 3%, OR¼7.34, 95% CI¼4.59, 11.74); NRT (47% vs 35%, OR¼1.63, 95% CI¼1.31, 2.03); or both counseling and NRT (16% vs 2%, OR¼11.93, 95% CI¼6.34, 22.47) after enrolling in the study. Appendix Table 2 (available online) displays the number of counseling calls completed by participants in the intervention group, based on study counselor documentation. Similar to results found on the follow-up surveys, most participants (n¼715, 74%) did not complete any calls. Twelve percent (n¼120) completed one to four calls; 5% (n¼53) completed five to eight calls; and 8% (n¼81) completed nine to 12 calls. Table 3 displays cessation outcomes by treatment arm. At 12 months, intervention participants were more likely May 2018

5 624 Rogers et al / Am J Prev Med 2018;54(5): Table 1. Baseline Participant Characteristics by Treatment Arm Variable Control (n¼969) Intervention (n¼969) Male gender, n (%) 844 (87.1) 841 (86.7) Mean age (SD) 58.9 (11.3) 58.3 (11.6) Race, n (%) White 595 (62.1) 603 (62.8) Black/African American 309 (32.3) 294 (30.6) American Indian/Alaska Native 6 (0.6) 7 (0.7) Asian 8 (0.8) 6 (0.6) Pacific Islander/Native Hawaiian 5 (0.5) 4 (0.4) Two or more races 35 (3.7) 44 (4.6) Other 0 (0.0) 3 (0.3) Missing 11 8 Education, n (%) Eighth grade or less 16 (1.7) 13 (1.4) Some high school/high school graduate/ged 386 (40.4) 377 (38.6) Associates degree/trade school/some college 447 (46.8) 446 (46.9) College graduate/bachelor s degree 72 (7.5) 89 (9.4) Graduate/professional degree 31 (3.3) 34 (3.6) Other 3 (0.3) 2 (0.2) Missing Annual income, n (%) o$10, (20.6) 192 (21.8) $10,000 $20, (32.7) 259 (29.4) $20,001 $40, (26.0) 252 (28.6) $40,001 $60, (14.8) 114 (12.9) $60,001 $80, (3.4) 35 (4.0) 4$80, (2.6) 29 (3.3) Missing Employment, n (%) Employed 220 (24.0) 199 (22.0) Out of work 96 (10.4) 107 (11.8) Homemaker 7 (0.8) 4 (0.4) Student 16 (1.7) 21 (2.3) Retired 292 (31.8) 283 (31.2) Unable to work/disabled 286 (31.2) 292 (32.2) Missing Mean cigarettes per day (SD) 14.7 (11.0) 15.4 (10.1) Missing Current electronic cigarette use, n (%) yes 129 (13.6) 146 (15.4) Missing Mean age of smoking initiation (SD) 17.6 (6.6) 17.5 (5.9) Missing 12 9 Minutes to smoke after waking, n (%) Within 5 minutes 247 (26.2) 285 (30.0) Within 6 30 minutes 390 (41.4) 376 (39.6) Within minutes 143 (15.2) 142 (15.0) After 60 minutes 163 (17.3) 146 (15.4) Missing Past quit attempt, n (%) yes 805 (84.1) 821 (86.3) Missing Past year use of telephone program to quit, n (%) yes 26 (2.7) 37 (3.9) (continued on next page)

6 Rogers et al / Am J Prev Med 2018;54(5): Table 1. Baseline Participant Characteristics by Treatment Arm (continued) Variable Control (n¼969) Intervention (n¼969) Missing Motivation to quit (1 10 scale), M (SD) 6.1 (2.7) 6.2 (2.7) Missing Confidence in quitting (1 10 scale), M (SD) 5.5 (2.5) 5.4 (2.6) Missing Kessler-6 total score, M (SD) 14.0 (6.1) 14.2 (6.2) Missing PHQ-8 total score, M (SD) 8.8 (7.0) 9.5 (6.9) Missing Primary psychiatric diagnosis a Anxiety 43 (5.3) 60 (7.3) Depression 131 (16.2) 115 (14.0) Unspecific alcohol dependence 49 (6.1) 69 (8.4) PTSD 95 (11.7) 66 (8.0) Serious mental illness 54 (6.7) 72 (8.8) Substance use disorder 401 (49.5) 385 (46.8) Other 37 (4.6) 55 (6.7) N missing Number of past-year primary care visits, M (SD) 4.2 (3.5) 4.0 (3.5) Number of past-year mental health visits, M (SD) 7.8 (18.9) 9.4 (22.3) a Primary psychiatric diagnosis was defined as the most frequently occurring ICD-9 diagnosis in the medical record in the year prior to randomization. The following diagnostic codes were used to categorize patients: PTSD (309.81); Anxiety Disorder (300.0, 300.2, 300.3, 308.0, 308.3, 308.4, 308.9); Substance Use Disorder excluding tobacco (303, 304, 305); Serious Mental Illness: bipolar, other psychoses, schizophrenia (296.0, 296.1, , 295, 298, 299); Other Mental Health Disorder ( , 316, , 305.1); and Unspecified Alcohol dependence (303.9). GED, general educational development test; PHQ-8, 8-item Patient Health Questionnaire; PTSD, post-traumatic stress disorder. to report 7-day abstinence from cigarettes (19% vs 14%, OR¼1.5, 95% CI¼1.1, 2.0); 7-day abstinence from any nicotine (13% vs 8%, OR¼1.6, 95% CI¼1.1, 2.2); and prolonged 6-month cigarette abstinence (16% vs 9%, OR¼1.9, 95% CI¼1.3, 2.6). After adjusting for nonignorable missingness at follow-up, the intervention effects on 7-day and prolonged abstinence remained significant (abstinence from cigarettes: OR¼1.6, 95% CI¼1.3, 2.0, abstinence from any nicotine: OR¼1.7, 95% CI¼1.4, 2.1, prolonged abstinence: OR¼2.0, 95% CI¼1.6, 2.4). At 6 months, saliva samples were received from 68% (50/73) of eligible intervention participants and 73% (33/ 45) of eligible control participants. There was 66% and 73% agreement between cotinine-verified abstinence and self-reported abstinence in the intervention and control participants, respectively, at 6 months (with no significant difference between groups, p40.05). At 12 months, saliva samples were received from 70% (53/76) of eligible intervention participants and 76% (44/58) of eligible control participants. At 12 months, there was 68% agreement between cotinine-verified and self-reported abstinence in both groups (p40.05). When examining self-reported 7-day cigarette abstinence at 12 months by the number of counseling calls completed, results showed that 9% (8/87) of participants who completed one to four calls were abstinent; 23% (9/39) of participants who completed five to eight calls were abstinent (OR¼2.9, 95% CI¼1.1, 8.4, vs one to four calls); and 41% (29/70) of participants who completed nine to 12 calls were abstinent (OR¼6.9, 95% CI¼2.9, 16.7, vs one to four calls). Table 2. Self-Reported Use of Treatment Among Survey Respondents at 12-Month Follow-up Outcome Intervention, % (n) (n¼620) Control, % (n) (n¼702) OR (95% CI) Use of telephone counseling 19.2 (119) 3.1 (22) 7.34 (4.59, 11.74) Use of nicotine replacement therapy (NRT) 46.6 (289) 34.9 (245) 1.63 (1.31, 2.03) Use of both NRT and telephone counseling 16.0 (99) 1.6 (11) (6.34, 22.47) Note: Boldface indicates statistical significance (po0.05). May 2018

7 626 Rogers et al / Am J Prev Med 2018;54(5): Table 3. Abstinence by Treatment Arm at 6- and 12-month Follow-up 6-month 12-month Outcome Intervention Control OR (95% CI) Intervention Control OR (95% CI) Self-reported 7-day abstinence from any nicotine Observed estimates 10.1% (73/723) 5.9% (45/769) 1.81 (1.23, 2.66) Adjusted for non-ignorable missingness 1.69 (1.33, 2.14) Self-reported 7-day abstinence from cigarettes Observed 20.1% 12.1% 1.82 estimates (146/726) (94/776) (1.37, 2.41) Adjusted for non-ignorable missingness 1.81 (1.46, 2.25) Self-reported 6-month prolonged abstinence from cigarettes Observed 13.5% 6.6% 2.21 estimates (94/696) (49/741) (1.54, 3.17) Adjusted for non-ignorable missingness 2.10 (1.65, 2.67) Agreement between cotinineverified and self-reported abstinence among saliva responders 66.0% (33/50) 72.7% (24/33) 0.73 (0.28, 1.91) 12.5% (76/608) 19.2% (119/620) 16.3% (101/620) 68.0% (36/53) 8.4% (58/690) 13.7% (96/701) 9.4% (66/700) 68.0% (30/44) 1.56 (1.09, 2.24) 1.71 (1.36, 2.14) 1.50 (1.12, 2.01) 1.62 (1.33, 1.98) 1.87 (1.34, 2.61) 1.95 (1.59, 2.41) 1.01 (0.43, 2.39) Note: Boldface indicates statistical significance (po0.05). DISCUSSION This study was the first to test a proactive tobacco treatment approach in smokers receiving mental health specialty care. This large RCT produced several important findings. First, the proactive tobacco treatment intervention led to significant increases in long-term abstinence compared with usual care. Almost 20% of all participants reported 7-day abstinence 1 year after enrolling. This occurred in a patient population with severe psychological distress and only moderate motivation to quit at enrollment (mean of 6 of 10). The intervention arm s quit rate is similar to other studies with smokers who have mental health conditions, 27,28 and slightly lower than the one found at 6 months in a previous study by Rogers et al. 9 testing the same intensive telephone counseling protocol in VA mental health patients (26%). In that study, participants had been referred by their mental health provider, so there may have been some referral bias, such that providers were more likely to offer referral or patients were more likely to accept referral if they had higher motivation to quit (about 70% of that sample were ready to quit within 30 days of enrolling). Of note, the prolonged 6-month abstinence rate found in the current study (16%) is similar to that found in prior research testing proactive tobacco treatment with VA primary care patients (14%) 14 and socioeconomically disadvantaged smokers (16%). 15 When examining potential mechanisms of the intervention s impact of abstinence, data showed that the intervention led to an eightfold increase in use of cessation counseling compared with usual care. This occurred in a population in which very few patients (3%) had used telephone counseling to help them quit in the year before the study. The control group s use of telephone counseling was just 3% at follow-up very similar to their use prior to enrolling in the study. This suggests that the mailing that the control group received with information about how to access usual tobacco cessation care did not lead to an increase in patient use of counseling. Of note, the proportion of patients who reported using telephone counseling at 1 year (19%) was similar to the proportion found in a prior proactive tobacco treatment study with VA primary care patients 14 (20%). However, the number of calls completed by intervention patients was low. Only 13% of participants completed more than four calls, with only 6% completing the full 12-call protocol. Self-reported abstinence rates were significantly higher among participants who completed more calls, suggesting that a higher counseling

8 dose led to higher abstinence rates (as has been found in prior research). However, as the study did not randomize participants to differing numbers of calls, it is not possible to determine causality of call dose. It is plausible that participants underlying motivation to quit led them to both engage in more calls and ultimately quit. When considering other potential mechanisms of the intervention, data showed that the intervention increased use of NRT and combined counseling plus NRT (the most effective treatment approach). This is likely because of the intervention counselors facilitation of NRT prescriptions and counseling around the importance of NRT use during a quit attempt. However, even in the control arm, 35% of patients used NRT, suggesting that the proactive mailing alone motivated many patients to use NRT. Taking the treatment use data together, the intervention s impact appears to be driven by its ability to increase use of evidence-based pharmacotherapy and some behavioral counseling. Additional work is needed to determine the optimal counseling dose required to achieve these effects. More work is also needed to increase overall treatment engagement rates in this population, as a large proportion of intervention participants did not use the telephone counseling that was available to them. Prior research has shown that most VA patients with mental health conditions have a phone, 29,30 so phone access was not likely the main driver of low rates of engagement. The investigators are currently conducting qualitative interviews with Veterans who did not respond to the proactive mailing and intervention arm participants who did not engage in or complete the counseling to understand their barriers to study and treatment engagement. This study adds to the growing literature supporting proactive, population-based approaches to tobacco treatment by showing that such an approach is more effective than referral-based usual VA care at increasing treatment engagement and long-term abstinence in mental health patients. A proactive tobacco treatment approach has been shown to be scalable at other healthcare systems, such as MD Anderson Cancer Center. 31 The study used three full-time employment equivalent counselors to conduct proactive phone outreach and counseling to 1,938 patients at four VA facilities over a 15-month period. A single counselor could feasibility handle an annual case of 500 patients, which could be higher outside the study setting without the increased administrative burden of research-related documentation. Although the current study s counselors had master s degrees, to reduce intervention costs and increase scalability, the proactive outreach calls could be completed by bachelor s-level or non-degreed staff (such as the Rogers et al / Am J Prev Med 2018;54(5): growing workforce of mental health peer specialists) who would then schedule interested patients for counseling with a master s-trained counselor. Limitations This study has some limitations. Following recommendations from the Society for Research on Nicotine and Tobacco for assessing smoking outcomes during population-based pragmatic trials, 32 the study did not biochemically validate all participants. Among participants who did return saliva samples, there was moderate misreporting of 7-day abstinence (32%), which was not significantly different between groups. A study of bipolar disorder patients in India similarly found 73% agreement between self-report and urinary cotinine, 33 and research with hospitalized smokers (with and without psychiatric illness) found misreporting of abstinence in 30% 50% of participants, with no difference in misreporting between the study s two arms. 34 Therefore, misreporting of abstinence may not bias between-group analyses, but supports the need to consider biochemically validating abstinence in all participants to assess accuracy of quit rate estimates. Another limitation is the study population; findings may not generalize outside the VA. In addition, the mailed survey response rate was relatively low (17%), compared with a previous study by Fu and colleagues 14 that used a more intensive outreach approach in VA primary care, in which 60% of patients mailed back a survey. Future proactive tobacco treatment efforts should utilize a more intensive outreach approach. Additionally, the VA is in an optimal position to explore future targeting and tailoring of proactive outreach to populations that were less likely to engage in the study (e.g., post-traumatic stress disorder patients) to increase treatment and abstinence rates in more difficult to reach patients. CONCLUSIONS This study supports proactive tobacco treatment approaches for smokers receiving mental health specialty care. Future research should identify the optimal proactive cessation counseling dose for mental health patients and methods for increasing treatment engagement. ACKNOWLEDGMENTS This study was funded by the Veterans Affairs Health Services Research & Development (IIR ). The study is registered at (NCT ). The findings and conclusions are those of the authors and do not necessarily May 2018

9 628 represent the official position of the Veterans Health Administration. S.E. Sherman and S.S. Fu were Principal Investigators on the trial. E.S. Rogers was Co-Investigator and Project Director, with responsibility for overseeing the study procedures and leading manuscript preparation. P. Krebs was Co-Investigator and contributed to the design and execution of study procedures, data interpretation, and manuscript preparation. S. Noorbaloochi was the study statistician and led the statistical analysis plans and interpretation. S. Nugent was the electronic medical record programmer and led the development of the recruitment cohorts and electronic medical record data abstraction. A. Gravely was the statistical programmer and contributed to the statistical analysis plans and interpretation. No financial disclosures were reported by the authors of this paper. SUPPLEMENTAL MATERIAL Supplemental material associated with this article can be found in the online version at REFERENCES 1. 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