Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial
Richard A Brown, Haruka Minami, Jacki Hecht, Christopher W Kahler, Lawrence H Price, Kimberly L Kjome, Erika Litvin Bloom, Douglas E Levy, Kelly M Carpenter, Ashleigh Smith, Jasper A J Smits, Nancy A Rigotti, Richard A Brown, Haruka Minami, Jacki Hecht, Christopher W Kahler, Lawrence H Price, Kimberly L Kjome, Erika Litvin Bloom, Douglas E Levy, Kelly M Carpenter, Ashleigh Smith, Jasper A J Smits, Nancy A Rigotti
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.
Conflict of interest statement
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.
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Source: PubMed