Dataset Information

Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

ABSTRACT: Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services. All participants are followed for 6months to assess the impact of the intervention on smoking abstinence and utilization of professional dental care. In addition, the study will assess the cost of the intervention and provide practical guidance to states on whether the intervention is financially feasible to implement, should the intervention be effective. This study protocol may be useful to others interested in promoting oral health among smokers, those interested in partnering with tobacco quitlines to extend standard services to address other high risk health behaviors among smokers, or those interested in semi-pragmatic trial design.

SUBMITTER: McClure JB

PROVIDER: S-EPMC5499697 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

McClure Jennifer B JB Blasi Paula R PR Cook Andrea A Bush Terry T Fishman Paul P Nelson Jennifer J Anderson Melissa L ML Catz Sheryl L SL

Contemporary clinical trials 20170412

Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are ...[more]

PMID: 28412230

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Project description:IntroductionWhile tobacco Quitlines are effective in the promotion of smoking cessation, the majority of callers who wish to quit still fail to do so. The aim of this study was to determine if 12-month tobacco Quitline smoking cessation rates could be improved with re-engagement of callers whose first Quitline treatment failed to establish abstinence.MethodsIn an adaptive trial, 614 adult smokers, who were active duty, retired, and family of military personnel with TRICARE insurance who called a tobacco Quitline, received a previously evaluated and efficacious four-session tobacco cessation intervention with nicotine replacement therapy (NRT). At the scheduled follow-up at 3 months, callers who had not yet achieved abstinence were offered the opportunity to re-engage. This resulted in three caller groups: 1) those who were abstinent, 2) those who were still smoking but willing to re-engage with an additional Quitline treatment; and 3) individuals who were still smoking but declined re-engagement. A propensity score-adjusted logistic regression model was generated to compare past-7-day point prevalence abstinence at 12 months post Quitline consultation.ResultsUsing a propensity score adjusted logistic regression model, comparison of the three groups resulted in higher odds of past-7-day point prevalence abstinence at follow-up at 12 months for those who were abstinent at 3 months compared to those who re-engaged (OR=9.6; 95% CI: 5.2-17.8; Bonferroni adjusted p<0.0001), and relative to those who declined re-engagement (OR=13.4; 95% CI: 6.8-26.3; Bonferroni adjusted p<0.0001). There was no statistically significant difference in smoking abstinence between smokers at 3 months who re-engaged and those who declined re-engagement (OR=1.39; 95% CI: 0.68-2.85).ConclusionsTobacco Quitlines seeking to select a single initiative by which to maximize abstinence at follow-up at 12 months may benefit from diverting additional resources from the re-engagement of callers whose initial quit attempt failed, toward changes which increase callers' probability of success within the first 3 months of treatment.Trial registrationThis study is registered at clinicaltrials.gov (NCT02201810).

Project description:ObjectivesApproximately 10% (40?000) of US quitline enrollees who smoke cigarettes report current use of electronic nicotine delivery systems (ENDS); however, little is known about callers' ENDS use. Our aim was to describe why and how quitline callers use ENDS, their beliefs about ENDS and the impact of ENDS use on callers' quit processes and use of FDA-approved cessation medications.DesignQualitative interviews conducted 1-month postregistration. Interviews were recorded, transcribed, double-coded and analysed to identify themes.SettingOklahoma Tobacco Helpline.Participants40 callers aged ?18 who were seeking help to quit smoking were using ENDS at registration and completed ?1 programme calls.ResultsAt 1-month postregistration interview, 80% of callers had smoked cigarettes in the last 7?days, almost two-thirds were using ENDS, and half were using cessation medications. Nearly all believed ENDS helped them quit or cut down on smoking; however, participants were split on whether they would recommend cessation medications, ENDS or both together for quitting. Confusion and misinformation about potential harms of ENDS and cessation medications were reported. Participants reported using ENDS in potentially adaptive ways (eg, using ENDS to cut down and nicotine replacement therapy to quit, and stepping down nicotine in ENDS to wean off ENDS after quitting) and maladaptive ways (eg, frequent automatic ENDS use, using ENDS in situations they did not previously smoke, cutting down on smoking using ENDS without a schedule or plan to quit), which could impact the likelihood of quitting smoking or continuing ENDS use.ConclusionsThese qualitative findings suggest quitline callers who use ENDS experience confusion and misinformation about ENDS and FDA-approved cessation medications. Callers also use ENDS in ways that may not facilitate quitting smoking. Opportunities exist for quitlines to educate ENDS users and help them create a coordinated plan most likely to result in completely quitting combustible tobacco.

Project description:IntroductionQuitlines are effective in helping smokers quit, but pediatrician quitline referral rates are low, and few parents who smoke use the service. This study compared enrollment of parents who smoke in the quitline using electronic referral with that using manual referral.Study designThe study was designed as a pragmatic RCT.Setting/participantsParticipants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families. Participants included adult parents who smoked and were present at their child's healthcare visit.InterventionPediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. Data were collected between March 2017 and February 2018 and analyzed in 2018.Main outcome measuresThe primary outcome was the proportion of parents enrolled in quitline treatment. Secondary outcomes included parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment. Number of quitline contacts was also explored.ResultsDuring the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6). Parents aged ≥50 years enrolled in the quitline more frequently. Although more parents in the eReferral group connected to the quitline, among parents who had at least one quitline contact, there was no significant difference in the mean number of quitline contacts between eReferral and control groups (mean, 2.04 vs 2.40 calls; difference, 0.36 [95% CI=0.35, 1.06]).ConclusionsSmoking parent eReferral from pediatric primary care may increase quitline enrollment and could be adopted by practices interested in increasing rates of parent treatment.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02997735.

Dataset Information

Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

Publications

Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

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