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Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric DisordersThe Helping HAND 3 Randomized Clinical Trial

Educational Objective
To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with serious mental illness (SMI) receiving inpatient psychiatric care.
1 Credit CME
Key Points

Question  Can a brief, multicomponent, sustained care smoking cessation intervention tailored to individuals with severe mental illness facilitate treatment engagement and abstinence following hospital discharge?

Findings  In this randomized clinical trial involving 353 adults with severe mental illness who reported smoking cigarettes, a sustained care smoking cessation intervention yielded greater treatment engagement and abstinence at 6 months following discharge than usual care.

Meaning  In this study, intervening during the psychiatric hospital stay using a patient-centered approach was effective at continuing the move toward smoking abstinence initiated during the hospital stay.

Abstract

Importance  Smoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting.

Objective  To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care.

Design, Setting, and Participants  The Helping HAND 3 randomized clinical trial compared SusC with usual care (UC) among individuals with SMI who smoked daily and were receiving inpatient psychiatric care in Austin, Texas, in a single hospital. The study was conducted from July 2015 through August 2019.

Interventions  The UC intervention involved brief smoking cessation information, self-help materials and advice from the admitting nurse, and an offer to provide nicotine replacement therapy during hospitalization. The SusC intervention included 4 main components designed to facilitate patient engagement with postdischarge smoking cessation resources: (1) inpatient motivational counseling; (2) free transdermal nicotine patches on discharge; (3) an offer of free postdischarge telephone quitline, text-based, and/or web-based smoking cessation counseling, and (4) postdischarge automated interactive voice response calls or text messages.

Main Outcomes and Measures  The primary outcome was biochemically verified 7-day point-prevalence abstinence at 6-month follow-up. A secondary outcome was self-reported smoking cessation treatment use at 1, 3, and 6 months after discharge.

Results  A total of 353 participants were randomized, of whom 342 were included in analyses (mean [SD] age, 35.8 [12.3] years; 268 White individuals [78.4%]; 280 non-Hispanic individuals [81.9%]; 169 women [49.4%]). They reported smoking a mean (SD) of 16.9 (10.4) cigarettes per day. Participants in the SusC group evidenced significantly higher 6-month follow-up point-prevalence abstinence rates than those in the UC group (8.9% vs 3.5%; adjusted odds ratio, 2.95 [95% CI, 1.24-6.99]; P = .01). The number needed to treat was 18.5 (95% CI, 9.6-306.4). A series of sensitivity analyses confirmed effectiveness. Finally, participants in the SusC group were significantly more likely to report using smoking cessation treatment over the 6 months postdischarge compared with participants in the UC group (74.6% vs 40.5%; relative risk, 1.8 [95% CI, 1.51-2.25]; P < .001).

Conclusions and Relevance  The findings of this randomized clinical trial provide evidence for the effectiveness of a scalable, multicomponent intervention in promoting smoking cessation treatment use and smoking abstinence in individuals with SMI following hospital discharge.

Trial Registration  ClinicalTrials.gov Identifier: NCT02204956

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Article Information

Accepted for Publication: March 2, 2021.

Published Online: May 5, 2021. doi:10.1001/jamapsychiatry.2021.0707

Corresponding Author: Richard A. Brown, PhD, School of Nursing, University of Texas at Austin, 1710 Red River St, Austin, TX 78712 (brown2@utexas.edu).

Correction: This article was corrected on June 9, 2021, to fix errors in the statistical results and again on November 3, 2021, to correct errors in Table 1. In the Sensitivity Analyses subsection, the adjusted odds ratio and 95% CI labeled “model 1,” 2.14 (95% CI, 1.11-4.11), should have been 2.22 (95% CI, 1.14-4.31). This error also appears in the Visual Abstract. Additionally, for the sensitivity analysis including unit as a covariate, the P value of .02 for the adjusted odds ratio 2.95 (95% CI, 1.26-6.91) should have instead been P = .01. Finally, in Table 2, in the section labeled “Missing equated to smoking,” the values for smoking biochemically verified or verified by a significant other were incorrect. The adjusted odds ratio was presented as 2.14 (95% CI, 1.11-4.11) but should have been 2.22 (95% CI, 1.14-4.31). The second correction fixed errors in Table 1: the number of past attempts at quitting for longer than 24 hours was reported as 3.9 for the usual care group but should have been 4.0; depressive symptoms per the PROMIS-D8a were reported as 18.9 (8.1) for the sustained care group and 19.0 (7.9) for the usual care group but should have been 26.9 (8.2) and 27.1 (7.8), respectively; anxiety symptoms per the PROMIS-A8a were reported as 19.4 (7.7) for the sustained care group and 20.0 (6.8) for the usual care group but should have been 27.4 (7.7) and 28.1 (6.8), respectively; psychotic symptoms per BASIS-24a were reported as 3.7 (4.2) for the sustained care group and 3.6 (3.8) for the usual care group but should have been reported as 0.9 (1.0) and 0.9 (0.9), respectively; emotional lability per BASIS-24a was reported as 6.4 (2.7) for the sustained care group and 6.7 (2.6) for the usual care group but should have been 2.1 (0.9) and 2.3 (0.9), respectively; and the median IQR for the length of hospital stay for the sustained care group was reported as 4 to 8 days but should have been 4 to 7 days. The errors have been corrected online.

The errors have been corrected online.

Author Contributions: Drs Brown and Minami had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses.

Concept and design: Brown, Hecht, Kahler, Bloom, Rigotti.

Acquisition, analysis, or interpretation of data: Brown, Minami, Kahler, Price, Kjome, Levy, Carpenter, Smith, Smits, Rigotti.

Drafting of the manuscript: Brown, Bloom, Smits.

Critical revision of the manuscript for important intellectual content: Brown, Minami, Hecht, Kahler, Price, Kjome, Bloom, Levy, Carpenter, Smith, Rigotti.

Statistical analysis: Minami, Kahler.

Obtained funding: Brown, Kahler, Bloom.

Administrative, technical, or material support: Brown, Hecht, Kjome, Carpenter, Smith, Smits.

Supervision: Brown, Rigotti.

Conflict of Interest Disclosures: Dr Brown reports a grant from the National Institute of Mental Health in the conduct of this study, a grant from the National Institute on Drug Abuse outside of the submitted work, consulting on other grants from the National Institutes of Health, grants from the University of Texas at Austin, personal fees from Influents Innovations for consulting on an grant from the National Institutes of Health, and equity ownership in Health Behavior Solutions Inc, which is developing products for tobacco cessation that are not related to this study. Dr Kahler reports grants outside of the submitted work from the National Cancer Institute, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Allergies and Infectious Diseases, as well as support as a coinvestigator and consultant on other grants from the National Institutes of Health and personal fees from University of Texas as a consultant on a National Institutes of Health grant supporting the submitted work during the conduct of the study. Dr Price reports grants and personal fees (for consulting) from the National Institute of Mental Health during the conduct of this study; personal fees for data safety monitoring board membership from Baylor University, Cleveland Clinic, Clexio Biosciences, Worldwide Clinical Trials, and Biohaven Pharmaceuticals; and editorial consulting fees from Wiley and Springer outside the submitted work. In addition, Dr Price had a patent for OCDScales with royalties paid for a psychometric instrument. Dr Bloom reports a grant from the National Institute on Drug Abuse (grant K23DA035288) outside of the submitted work; personal fees from the National Institute of Mental Health for consulting during the conduct of this study; and personal fees from WayBetter Inc outside the submitted work. Dr Levy reports a grant from the National Heart, Lung, and Blood Institute outside of the submitted work and grants from National Institutes of Health during the conduct of the study. Dr Carpenter is an employee of Optum, the provider of the quitline program used in this study. Dr Smits reports grants from National Institute of Mental Health during the conduct of the study; personal fees from Big Health Ltd, Aptinyx, Elsevier, American Psychological Association, and Oxford University Press; and grants from National Institute on Drug Abuse and Cancer Prevention and Research Institute of Texas outside the submitted work. Dr Rigotti reports a grant from the National Institute of Mental Health in the conduct of this study and a grant from the National Heart, Lung, and Blood Institute outside of the submitted work; fees for consulting for Achieve Life Sciences for an investigational smoking cessation aid that is not related to this study; unpaid consulting and nonfinancial support from Pfizer to travel to a meeting for Pfizer, which markets varenicline, also not used in this study; and royalties from UpToDate for reviews of smoking cessation treatments, outside the submitted work. Dr Minami reported grants from National Institute of Mental Health during the conduct of the study and grants from National Institute on Drug Abuse outside the submitted work. No other disclosures were reported.

Funding/Support: This research was funded by the National Institute of Mental Health (grant R01MH104562 [Drs Brown and Rigotti]).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2.

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