A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study.

BACKGROUND: Cigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings. METHODS: This manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke-regardless of interest in quitting- are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS. DISCUSSION: This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke. TRIAL REGISTRATION: Registered at ClincalTrials.gov (NCT05627596) on 11/25/2022.

Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial.

BACKGROUND: Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) each year in the US. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS. A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality. METHOD/DESIGN: The overall aim of the current study is to conduct a fully powered efficacy trial enrolling 324 smokers with ACS and randomizing them to 12 weeks of an integrated smoking cessation and mood management treatment [Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)] or control (smoking cessation and general health education). Both groups will be offered 8 weeks of the nicotine patch if medically cleared. Counseling in both arms will be provided by tobacco treatment specialists. Follow-up assessments will be conducted at end-of-treatment (12-weeks) and 6, 9, and 12 months after hospital discharge. We will track major adverse cardiac events and all-cause mortality for 36 months post-discharge. Primary outcomes are depressed mood and biochemically validated 7-day point prevalence abstinence from smoking over 12 months. DISCUSSION: Results of this study will inform smoking cessation treatments post-ACS and provide unique data on the impact of depressed mood on success of post-ACS health behavior change attempts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03413423. Registered 29 January 2018. https://beta. CLINICALTRIALS: gov/study/NCT03413423 .

Implementing Chronic Care Model Treatments for Cigarette Dependence in Community Mental Health Clinics.

Objective: Tobacco use is rarely addressed in community mental healthcare settings, despite its high prevalence among people with serious mental illness. The aim of the current study was to gather stakeholder feedback regarding the feasibility of chronic care management strategies for tobacco dependence in community mental health centers (CMHCs). Chronic care strategies evaluated included the 5 As (Ask about tobacco use, Advise users of tobacco to quit, Assess interest in cessation, Assist with cessation, and Arrange for follow-up) and proactive telephone outreach (reaching out to all users of tobacco to offer connection to tobacco cessation treatment). Methods: Using a semi-structured interview guide informed by the Practical Robust Implementation and Sustainability Model, we conducted individual semi-structured interviews with providers, leaders, and clients across two CMHCs. Our objectives were to capture their attitudes toward smoking cessation treatment, two chronic care model interventions (i.e., proactive outreach, the 5 As), and to determine the infrastructure needed to implement such interventions in their CMHCs. Thematic analysis was conducted by two independent coders to uncover pertinent themes. Results: Participants (n = 20) included nine providers, six leaders, and five clients. Thematic analysis revealed three major themes: (1) characteristics of recipients, (2) characteristics of the intervention, and (3) infrastructure needed for implementation and sustainability. Providers, leaders, and clients all reported that tobacco cessation treatment was rarely provided in CMHCs and expressed an interest in such treatments becoming more available. The 5 As and proactive outreach were viewed as feasible and acceptable to deliver and receive. Providers, leaders, and clients wanted support to connect clients with smoking cessation treatment. Providers and leaders requested a range of implementation supports, including didactic trainings, decision aids, performance feedback, and coaching on evidence-based tobacco cessation treatments for people with serious mental illness. Clients requested tobacco cessation resources, such as a cessation counseling provided at the CMHC and prescriptions for cessation medication. Conclusions: CMHC providers, leaders, and clients are interested in making tobacco cessation services more widely accessible and available. The feedback gathered in this study can be used to inform the delivery and implementation of guideline-adherent tobacco dependence care in CMHCs.

The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome.

BACKGROUND: Patients with acute coronary syndrome (ACS) with depressed mood demonstrate poor cardiovascular behavioral risk profiles and elevated risk for recurrent ACS and mortality. Behavioral Activation (BA) offers an intervention framework for an integrated treatment targeting both depression and critical health behaviors post-ACS. Behavioral Activation for Health and Depression (BA-HD) was developed and pilot tested in a multiphase iterative process. METHODS: First, an initial treatment manual was conceptualized based on the team's prior work, as well as the extant literature. Second, qualitative interviews were conducted with target patients and target providers on the proposed BA-HD treatment rationale, content, and structure. Framework matrix analyses were used to summarize and aggregate responses. Third, an expert panel was convened to elicit additional manual refinements. Finally, patients with post-ACS depression and health behavior non-adherence were recruited to complete an open pilot trial to evaluate acceptability (Client Satisfaction Questionnaire [CSQ], exit interview) and treatment engagement (number of sessions attended; treatment completion was considered completion of 8 out of 10 possible sessions). RESULTS: The initial BA-HD treatment manual expanded an existing treatment manual for post-ACS BA-based mood management and smoking cessation to target four health behaviors relevant to post-ACS patients (e.g., smoking cessation, medication adherence, physical activity, and diet). After the initial conceptualization, ten post-ACS patients and eight cardiac rehabilitation professionals completed qualitative interviews. Patients endorsed bi-directional interactions between mood and health behaviors post-ACS. Both patients and providers expressed general support of the proposed treatment rationale and values-guided, collaborative goal-setting approach. Patients, providers, and experts provided feedback that shaped the iterative manual development. After the BA-HD manual was finalized, eight participants were enrolled in a single-arm pilot trial. The mean CSQ score was 30.57 ± 2.23, indicating high satisfaction. Seven out of eight (88%) completed treatment. Pre- to post treatment improvements in depressed mood and health behaviors were promising. CONCLUSIONS: BA-HD treatment is an acceptable approach to target both mood and health behaviors in post-ACS patients with depression. A future larger, controlled trial is needed to evaluate the efficacy of the BA-HD treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04158219.

Knowledge, Attitudes, and Beliefs about Relapse Prevention Research Involving Bupropion among Current and Former Pregnant Individuals Who Smoke.

Introduction: While many individuals quit smoking during pregnancy, most relapse within one year postpartum. Research into methods to decrease smoking relapse postpartum has been hampered by difficulties with recruitment. Method: We conducted individual interviews with pregnant women (N = 22) who were interested in quitting smoking while pregnant about their attitudes regarding smoking and quitting during pregnancy, clinical trial participation, and smoking cessation medication use. Results: Participants were aware of the risks of smoking while pregnant. Many wanted to quit smoking before delivery. Few used empirically supported treatments to quit. While research was viewed positively, interest in taking on new commitments postpartum and taking a medication to prevent relapse was low. Medication concerns were evident among most participants, especially among those planning to breastfeed. Further, several women noted medication was unnecessary, as they did not believe they would relapse postpartum. Financial incentives, childcare, and fewer and/or remote visits were identified as facilitators to participating in research. However, these factors did not outweigh women's concerns about medication use and time commitments. Conclusions: Women are aware that quitting smoking during pregnancy and remaining smoke-free postpartum are important. However, beliefs that personal relapse risk is low and that medications are dangerous reduced enthusiasm for taking medication for postpartum relapse prevention. Future medication trials should educate women about the high likelihood of relapse, prepare to answer detailed questions about risks of cessation medications, and connect with participants' clinicians. For new mothers, studies conducted remotely with few scheduled appointments would reduce barriers to participation.

Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial.

BACKGROUND: Rates of smoking among those with serious mental illness (SMI) are two to three times higher than for the general population. Smoking is rarely addressed in mental health settings. Innovative outreach and treatment strategies are needed to address these disparities. The current study is a pilot study of the feasibility and acceptability of a chronic care model of tobacco cessation treatment implemented in outpatient psychiatry clinics. METHODS: Participants were recruited from two outpatient psychiatric clinics and randomly assigned to intervention (counseling and nicotine replacement for 8 weeks, plus ongoing proactive outreach calls inviting reengagement in treatment) or control (brief education and referral to the state quit line). Assessments were conducted at 8 weeks (end of initial treatment block) and 6 months (end of window for retreatment). Feasibility was assessed by enrollment rate, treatment engagement, and completion of follow-up assessments. Acceptability was assessed both quantitatively and qualitatively. Preliminary efficacy was assessed by 7-day and 30-day abstinence rates, rate of quit attempts, and cigarettes per day. Psychological health was measured to assess for changes related to treatment group or attempts to quit smoking. RESULTS: Nineteen participants were randomized to intervention and 19 to control. Recruitment proved feasible, and high rates of treatment engagement (mean of 4.5 sessions completed in initial treatment block, 89.5% uptake of nicotine replacement) and retention (94.7% of follow-up assessments completed) were observed. Treatment acceptability was high. As anticipated, there were no significant differences in abstinence between groups, but results generally favored the intervention group, including bio-verified 7-day abstinence rates of 21.1% in intervention vs. 17.6% in control and self-reported 30-day abstinence rates of 16.1% in intervention vs. 5.1% in control at 8 weeks. Significantly more intervention participants made at least one quit attempt (94.7% vs 52.6%; OR = 16.20, 95% CI: 1.79-147.01). Cigarettes per day decreased significantly more in the intervention group at 8 weeks (b = - 13.19, SE = 4.88, p = .02). CONCLUSIONS: It was feasible to recruit and retain SMI patients in a smoking cessation trial in the context of outpatient psychiatry. The novel chronic care model treatment was acceptable to patients and showed promise for efficacy. If efficacious, a chronic care model could be effective at reducing smoking among SMI patients. TRIAL REGISTRATION: ClinicalTrial.gov #: NCT03822416 (registered January 30th 2019).

Experiences with Work and Participation in Public Programs by Low-Income Medicaid Enrollees Using Qualitative Interviews.

BACKGROUND: Centers for Medicare & Medicaid Services (CMS) began encouraging governors to implement work requirements for Medicaid enrollees using section 1115 waivers in 2018. Significant controversy surrounds such attempts, but we know little about the perceptions and experiences of enrollees. OBJECTIVE: To characterize experiences of work and its relationship to participation in Medicaid and other public programs among potential targets of Medicaid work requirements. DESIGN: In-depth, semi-structured, one-time qualitative interviews. PARTICIPANTS: 35 very low-income, non-disabled Medicaid expansion enrollees participating in a county-sponsored Medicaid managed care plan as a part of a larger study. APPROACH: We used a biographical narrative interpretive method during interviews including questions about the use of employment and income support and other public programs including from state and federal disability programs. Our team iteratively coded verbatim transcripts allowing for emergent themes. KEY RESULTS: Interview data revealed high motivation for, and broad participation in, formal and informal paid work. Eight themes emerged: (1) critical poverty (for example, "I'm not content, but what choices do I have?"); (2) behavioral and physical health barriers to work; (3) social barriers: unstable housing, low education, criminal justice involvement; (4) work, pride, and shame; (5) inflexible, unstable work (for example, "Can I have a job that will accommodate my doctor appointments?…Will my therapy have to suffer? You know? So it's a double edged sword."); (6) Medicaid supports the ability to work; (7) lack of transparency and misalignment of program eligibility (for example, "It's not like I don't want to work because I would like to work. It's just that I don't want to be homeless again, right?"); and (8) barriers, confusion, and contradictions about federal disability. CONCLUSIONS: We conclude that bipartisan solutions prioritizing the availability of well-paying jobs and planful transitions off of public programs would best serve very low-income, work-capable Medicaid enrollees.