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      Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial

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          Abstract

          Background

          Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality.

          Methods

          The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the state's publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the state's telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey.

          Findings

          The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40).

          Interpretation

          Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use.

          Trial registration number

          NCT01123967.

          Related collections

          Most cited references21

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          Measures of abstinence in clinical trials: issues and recommendations.

          A workgroup formed by the Society for Research on Nicotine and Tobacco reviewed the literature on abstinence measures used in trials of smoking cessation interventions. We recommend that trials report multiple measures of abstinence. However, at a minimum we recommend that trial: (a) report prolonged abstinence (i.e., sustained abstinence after an initial period in which smoking is not counted as a failure) as the preferred measure, plus point prevalence as a secondary measure; (b) use 7 consecutive days of smoking or smoking on > or = 1 day of 2 consecutive weeks to define treatment failure; (c) include non-cigarette tobacco use, but not nicotine medications in definitions of failure; and (d) report results from survival analysis to describe outcomes more fully. Trials of smokers willing to set a quit date should tie all follow-ups to the quit date and report 6- and/or 12-month abstinence rates. For these trials, we recommend an initial 2-week grace period for prolonged abstinence definitions; however, the period may vary, depending on the presumed mechanism of the treatment. Trials of smokers who may not be currently trying to quit should tie follow-up to the initiation of the intervention and should report a prolonged abstinence measure of > or = 6-month duration and point prevalence rates at 6- and 12-month follow-ups. The grace period for these trials will depend on the time necessary for treatment dissemination, which will vary depending on the treatment, setting, and population. Trials that use short-term follow-ups ( or = 4 weeks. We again recommend a 2-week grace period; however, that period can vary.
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            The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation.

            Presents evidence for the validity of the Contemplation Ladder, a measure of readiness to consider smoking cessation. Analyses of data collected from more than 400 smokers at two worksites before and during a 10-month intervention indicate that Ladder scores were significantly associated with reported intention to quit, number of previous quit attempts, perceived co-worker encouragement to quit, and socioeconomic status. Ladder scores predicted subsequent participation in programs designed to educate workers about their smoking habit and its contingent risks. The Ladder did not predict biochemically validated abstinence of 24 hr or more. To assess its ability to distinguish between groups known a priori to differ in readiness, we administered the Ladder to 36 participants in a clinic-based smoking cessation program. As predicted, clinic patients scored significantly higher than the workers on the Ladder. The importance of distinguishing between smokers at the lowest stages of readiness to quit is discussed.
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              Evidence of real-world effectiveness of a telephone quitline for smokers.

              Telephone services that offer smoking-cessation counseling (quitlines) have proliferated in recent years, encouraged by positive results of clinical trials. The question remains, however, whether those results can be translated into real-world effectiveness. We embedded a randomized, controlled trial into the ongoing service of the California Smokers' Helpline. Callers were randomly assigned to a treatment group (1973 callers) or a control group (1309 callers). All participants received self-help materials. Those in the treatment group were assigned to receive up to seven counseling sessions; those in the control group could also receive counseling if they called back for it after randomization. Counseling was provided to 72.1 percent of those in the treatment group and 31.6 percent of those in the control group (mean, 3.0 sessions). The rates of abstinence for 1, 3, 6, and 12 months, according to an intention-to-treat analysis, were 23.7 percent, 17.9 percent, 12.8 percent, and 9.1 percent, respectively, for those in the treatment group and 16.5 percent, 12.1 percent, 8.6 percent, and 6.9 percent, respectively, for those in the control group (P<0.001). Analyses factoring out both the subgroup of control subjects who received counseling and the corresponding treatment subgroup indicate that counseling approximately doubled abstinence rates: rates of abstinence for 1, 3, 6, and 12 months were 20.7 percent, 15.9 percent, 11.7 percent, and 7.5 percent, respectively, in the remaining subjects in the treatment group and 9.6 percent, 6.7 percent, 5.2 percent, and 4.1 percent, respectively, in the remaining subjects in the control group (P<0.001). Therefore, the absolute difference in the rate of abstinence for 12 months between the remaining subjects in the treatment and control groups was 3.4 percent. The 12-month abstinence rates for those who made at least one attempt to quit were 23.3 percent in the treatment group and 18.4 percent in the control group (P<0.001). A telephone counseling protocol for smoking cessation, previously proven efficacious, was effective when translated to a real-world setting. Its success supports Public Health Service guidelines calling for greater availability of quitlines. Copyright 2002 Massachusetts Medical Society
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                Author and article information

                Journal
                Thorax
                Thorax
                thoraxjnl
                thorax
                Thorax
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0040-6376
                1468-3296
                May 2016
                1 March 2016
                : 71
                : 5
                : 446-453
                Affiliations
                [1 ]VA HSR&D Center for Chronic Disease Outcomes Research , Minneapolis, Minnesota, USA
                [2 ]Department of Medicine, University of Minnesota Medical School , Minneapolis, Minnesota, USA
                [3 ]Division of Health Care Policy & Research, Mayo Clinic , Rochester, Minnesota, USA
                [4 ]North American Quitline Consortium , Phoenix, Arizona, USA
                [5 ]Division of Health Policy and Management, University of Minnesota School of Public Health , Minneapolis, Minnesota, USA
                Author notes
                [Correspondence to ] Dr Steven S Fu, Center for Chronic Disease Outcomes Research (CCDOR), Minneapolis VA Health Care System, 1 Veterans Drive (152), Minneapolis, MN 55417, USA; Steven.Fu@ 123456va.gov
                Article
                thoraxjnl-2015-207904
                10.1136/thoraxjnl-2015-207904
                4862067
                26931362
                9096e910-410f-4ddb-87f7-36c26ce9fcf4
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 11 October 2015
                : 30 December 2015
                : 5 January 2016
                Categories
                1506
                Smoking
                Original article
                Custom metadata
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                Surgery
                smoking cessation,tobacco control
                Surgery
                smoking cessation, tobacco control

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