A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation

Evins, A. Eden; Cather, Corinne; Maravic, Melissa Culhane; Reyering, Sally; Pachas, Gladys; Thorndike, Anne N.; Levy, Douglas E.; Fung, Vicki; Fischer, Michael; Schnitzer, Kristina; Pratt, Sarah I.; Fetters, Michael D.; Deeb, Bianca; Potter, Kevin; Schoenfeld, David

doi:10.1176/appi.ps.20220187

Cited by 8 publications

(13 citation statements)

References 46 publications

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“…Shorter-duration smoking cessation interventions (8-12 weeks) have been the most commonly studied intervention for persons with SMI, with some reports of longer interventions ranging from 6 to 12 months . The engagement and success of participants in this 18-month intervention and a recent 24-month intervention suggest that interventions with an extended duration are beneficial for individuals with SMI, consistent with conceptualization of tobacco dependence as a chronic condition. The high smoking abstinence rates attained in this community-based trial are consistent with those of prior studies of pharmacologic and behavioral treatment for smoking cessation in persons with SMI conducted in more controlled drug trials and higher than those in most prior studies in community settings …”

Section: Discussionsupporting

confidence: 84%

“…Although the study psychiatrist (U.M.) communicated with participants’ treating psychiatrists, the intervention did not face the barrier of relying on physicians in the community to prescribe smoking cessation pharmacotherapy . As such, this study extends previous findings in a depression clinic that excellent results can be achieved in the community when pharmacotherapy and tailored behavioral support for cessation are offered over time …”

Section: Discussionmentioning

confidence: 58%

“…Accordingly, smokers with SMI are unlikely to receive treatment for tobacco use disorder despite guidelines recommending combined pharmacologic and behavioral tobacco use disorder treatment for all smokers, regardless of readiness to quit . Compounding this issue is the limited evidence of efficacy of smoking cessation interventions among persons with SMI who are not ready to quit right away, including lack of studies reporting outcomes by readiness to quit.…”

Section: Introductionmentioning

confidence: 99%

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Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness

et al. 2023

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ImportanceTobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the high prevalence of overweight/obesity that smoking cessation can exacerbate. Guideline-concordant combined pharmacotherapy and behavioral smoking cessation treatment improves abstinence but is not routinely offered in community settings, particularly to those not seeking to quit smoking immediately.ObjectiveTo determine the effectiveness of an 18-month pharmacotherapy and behavioral smoking cessation intervention incorporating weight management and support for physical activity in adults with serious mental illness interested in quitting smoking within 1 or 6 months.Design, Setting, and ParticipantsThis was a randomized clinical trial conducted from July 25, 2016, to March 20, 2020, at 4 community health programs. Adults with serious mental illness who smoked tobacco daily were included in the study. Participants were randomly assigned to intervention or control, stratified by willingness to try to quit immediately (within 1 month) or within 6 months. Assessors were masked to group assignment.InterventionsPharmacotherapy, primarily varenicline, dual-form nicotine replacement, or their combination; tailored individual and group counseling for motivational enhancement; smoking cessation and relapse prevention; weight management counseling; and support for physical activity. Controls received quitline referrals.Main Outcome and MeasuresThe primary outcome was biochemically validated, 7-day point-prevalence tobacco abstinence at 18 months.ResultsOf the 298 individuals screened for study inclusion, 192 enrolled (mean [SD] age, 49.6 [11.7] years; 97 women [50.5%]) and were randomly assigned to intervention (97 [50.5%]) or control (95 [49.5%]) groups. Participants self-identified with the following race and ethnicity categories: 93 Black or African American (48.4%), 6 Hispanic or Latino (3.1%), 90 White (46.9%), and 9 other (4.7%). A total of 82 participants (42.7%) had a schizophrenia spectrum disorder, 62 (32.3%) had bipolar disorder, and 48 (25.0%) had major depressive disorder; 119 participants (62%) reported interest in quitting immediately (within 1 month). Primary outcome data were collected in 183 participants (95.3%). At 18 months, 26.4% of participants (observed count, 27 of 97 [27.8%]) in the intervention group and 5.7% of participants (observed count, 6 of 95 [6.3%]) in the control group achieved abstinence (adjusted odds ratio [OR], 5.9; 95% CI, 2.3-15.4; P &lt; .001). Readiness to quit within 1 month did not statistically significantly modify the intervention’s effect on abstinence. The intervention group did not have significantly greater weight gain than the control group (mean weight change difference, 1.6 kg; 95% CI, −1.5 to 4.7 kg).Conclusions and RelevanceFindings of this randomized clinical trial showed that in persons with serious mental illness who are interested in quitting smoking within 6 months, an 18-month intervention with first-line pharmacotherapy and tailored behavioral support for smoking cessation and weight management increased tobacco abstinence without significant weight gain.Trial RegistrationClinicalTrials.gov Identifier: NCT02424188

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 58%

Section: Introductionmentioning

confidence: 99%

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Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness

et al. 2023

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“…Missing data for Year 2 tobacco abstinence in 43 participants were imputed ten times via predictive mean-matching using Year 1 abstinence outcomes and baseline characteristics, per the parent study [16].…”

Section: Discussionmentioning

confidence: 99%

“…CHWs improve hypertension, diabetes, and HIV/AIDS outcomes [18]. In a recent pragmatic clinical trial [19], we demonstrated that CHW support both to adults with SMI and TUD and also their primary care physicians (PCPs) for two years, combined with provider education (PE) on evidence-based TUD treatment in people with SMI, increased bio-verified tobacco abstinence rates over usual care or PE alone, in part through increased varenicline initiation. There was also an independent effect of the CHW; participants who received TUD pharmacotherapy with CHW support were three-fold more likely to quit smoking than those receiving TUD pharmacotherapy without CHW support [19].…”

Section: Introductionmentioning

confidence: 99%

Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study

Foo,

Potter,

Nielsen

et al. 2024

Preprint

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Objective: Adults with serious mental illness (SMI) have high tobacco use disorder (TUD) rates and underutilization of first-line TUD pharmacotherapy. In a randomized trial, a community health worker (CHW) plus primary care provider (PCP) education (PE) intervention improved tobacco abstinence in this population at two years, partly through increasing TUD pharmacotherapy initiation. The current study determined how engagement between participants and CHWs was associated with these outcomes. Methods: This was a secondary, mixed-methods analysis of 196 participants in the PE+CHW arm of the RCT. Effects of CHW visit number and duration (minutes), CHW co-led smoking cessation group sessions attended, and CHW-attended PCP visit number on TUD pharmacotherapy initiation and tobacco abstinence were modeled using logistic regression. Interviews with 12 CHWs, 16 participants, and 17 PCPs were analyzed thematically. Results: Year-two tobacco abstinence was associated with one standard deviation increase in CHW visit number (OR=1.85, z-score [1.29, 2.66]) and duration (OR=1.85, [1.33, 2.58]) and number of groups attended (OR=1.51, [1.00, 2.28]); effects on TUD pharmacotherapy initiation were similar. 1-3 CHW visits per month over two years were optimal for achieving abstinence. Interviews identified engagement facilitators, including CHWs providing goal accountability, skills reinforcement, and assistance in overcoming barriers to treatment access and adherence. Robust training and supervision facilitated CHW effectiveness. Barriers included PCPs' and care teams' limited understanding of the CHW role. Conclusions: Greater CHW engagement within feasible dose ranges was associated with increased tobacco abstinence in adults with SMI. Implementation of CHW interventions may benefit from promoting CHW training and integration within clinical teams.

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Alternative combusted tobacco product and multiple tobacco product use among individuals with serious mental illness enrolled in a large pragmatic randomized controlled trial

Streck,

Potter,

Pachas

et al. 2024

Addictive Behaviors

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A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation

Cited by 8 publications

References 46 publications

Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness

Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness

Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study

Alternative combusted tobacco product and multiple tobacco product use among individuals with serious mental illness enrolled in a large pragmatic randomized controlled trial

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