Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study.

BACKGROUND: Most smokers are ambivalent about quitting-they want to quit someday, but not now. Interventions are needed that can engage ambivalent smokers, build their motivation for quitting, and support future quit attempts. Mobile health (mHealth) apps offer a cost-effective platform for such interventions, but research is needed to inform their optimal design and assess their acceptability, feasibility, and potential effectiveness. OBJECTIVE: This study aims to assess the feasibility, acceptability, and potential impact of a novel mHealth app for smokers who want to quit smoking someday but are ambivalent about quitting in the near term. METHODS: We enrolled adults across the United States who smoked more than 10 cigarettes a day and were ambivalent about quitting (n=60). Participants were randomly assigned to 1 of 2 versions of the GEMS app: standard care (SC) versus enhanced care (EC). Both had a similar design and identical evidence-based, best-practice smoking cessation advice and resources, including the ability to earn free nicotine patches. EC also included a series of exercises called experiments designed to help ambivalent smokers clarify their goals, strengthen their motivation, and learn important behavioral skills for changing smoking behavior without making a commitment to quit. Outcomes were analyzed using automated app data and self-reported surveys at 1 and 3 months post enrollment. RESULTS: Participants who installed the app (57/60, 95%) were largely female, White, socioeconomically disadvantaged, and highly nicotine dependent. As expected, key outcomes trended in favor of the EC group. Compared to SC users, EC participants had greater engagement (mean sessions 19.9 for EC vs 7.3 for SC). An intentional quit attempt was reported by 39.3% (11/28) of EC users and 37.9% (11/29) of SC users. Seven-day point prevalence smoking abstinence at the 3-month follow-up was reported by 14.7% (4/28) of EC users and 6.9% (2/29) of SC users. Among participants who earned a free trial of nicotine replacement therapy based on their app usage, 36.4% (8/22) of EC participants and 11.1% (2/18) of SC participants requested the treatment. A total of 17.9% (5/28) of EC and 3.4% (1/29) of SC participants used an in-app feature to access a free tobacco quitline. Other metrics were also promising. EC participants completed an average of 6.9 (SD 3.1) out of 9 experiments. Median helpfulness ratings for completed experiments ranged from 3 to 4 on a 5-point scale. Finally, satisfaction with both app versions was very good (mean 4.1 on a 5-point Likert scale) and 95.3% (41/43) of all respondents would recommend their app version to others. CONCLUSIONS: Ambivalent smokers were receptive to the app-based intervention, but the EC version, which combined best-practice cessation advice with self-paced, experiential exercises, was associated with greater use and evidence of behavior change. Further development and evaluation of the EC program is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04560868; https://clinicaltrials.gov/ct2/show/NCT04560868.

Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial.

Smokers are at high risk of oral disease and report sub-optimal oral hygiene. Improving smokers' oral hygiene could reduce their future disease risk. The purpose of this study is to assess the effects of a novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L) targeted to socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines. Smokers (n = 718) were randomized to standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention and were advised of the benefits of routine oral hygiene, encouraged to brush and floss daily (for better oral health and to manage cigarette cravings), and provided a toothbrush and floss. Participants were followed for 6 months to assess the intervention effects on routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy. Data were collected between 2015 and 2017. At 2-month follow-up, OH4L participants were more likely to meet the American Dental Association (ADA) recommendations for brushing twice daily (adjusted RR = 1.15 [1.04, 1.27], p = .006), flossing daily (adjusted RR = 1.20 [1.03, 1.39], p = .02), and for both brushing and flossing (adjusted RR = 1.33 [1.10, 1.61], p = .003). Daily flossing was more likely at 6-month follow-up (adjusted RR = 1.21 [1.04, 1.42], p = .02) among OH4L participants. The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months. Integrating oral hygiene promotion with standard tobacco quitline services improved oral health self-care.

Oral Health Promotion and Smoking Cessation Program Delivered via Tobacco Quitlines: The Oral Health 4 Life Trial.

OBJECTIVES: To assess the effects of a novel oral health promotion program (Oral Health 4 Life; OH4L) delivered through state-funded tobacco quitlines. METHODS: Using a semipragmatic design to balance experimental control and generalizability, we randomized US quitline callers (n = 718) to standard care or standard care plus OH4L. We followed participants for 6 months to assess effects on professional dental care and smoking abstinence. We collected data between 2015 and 2017. RESULTS: Participants were racially diverse (42% non-White) and socioeconomically disadvantaged. Most (71%) reported fair or poor oral health, and all were overdue for routine dental care. At 6 months, professional dental care and abstinence did not significantly differ between arms, but abstinence favored the experimental arm and was significantly higher among experimental participants at 2 months in a complete case sensitivity analysis. CONCLUSIONS: OH4L was not effective for promoting dental care, but integrating oral health counseling with quitline counseling may offer some advantage for smoking cessation. Public Health Implications. We offer a model for conducting semipragmatic trials and partnering with tobacco quitlines to evaluate population-level public health interventions.

Evaluation of a population-level strategy to promote tobacco treatment use among insured smokers: a pragmatic, randomized trial.

BACKGROUND: Most smokers do not use evidence-based smoking cessation treatment. Increasing utilization of these services is an important public health goal. Health care systems and insurers are well positioned to support this goal within their patient populations. We tested whether a brief, mail-based intervention increased utilization of tobacco cessation services among insured smokers. METHODS: Adult smokers were identified via automated health plan data and randomized to one of five treatment arms (n = 4767). Randomization was stratified by gender, age, and type of health plan coverage. Three arms received a letter containing motivational content and treatment referral information. Motivational content emphasized either the financial, health, or values-based benefits of quitting. One arm received a referral letter with no motivational content, and one arm received no letter. Enrollment in the referred tobacco cessation program was monitored for 5 months. Treatment was available to all participants through their insurance. RESULTS: Across all four letter conditions, 0.8% of participants enrolled in tobacco treatment compared to 0.9% in the no letter reference group (p = .69). No single letter condition was superior to the others (p = .71), but treatment uptake was greater among participants who received their care and coverage from the health plan versus those with insurance coverage only (1.2% vs. 0.3%, p < .01). CONCLUSIONS: A one-time, mailed letter is not a cost-effective strategy for promoting use of covered smoking cessation treatment within large health plan populations, particularly when the message source is an insurance provider only and does not also provide clinical care. Health plans and insurers should consider alternative outreach efforts to promote treatment uptake among smokers. TRIAL REGISTRATIONS: TRN registered retrospectively with ISRCTN registry ( www.isrctn.com ). Registered on 11/01/2018. Registration number: ISRCTN32311137 .

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.

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.

[More] evidence to support oral health promotion services targeted to smokers calling tobacco quitlines in the United States.

BACKGROUND: Prior research demonstrated a need and opportunity to target smokers calling a free, state-funded tobacco quitline to provide behavioral counseling for oral health promotion; however, it is unclear whether these results generalize to tobacco quitline callers of higher socioeconomic status receiving services through commercially-funded quitlines. This knowledge will inform planning for a future public oral health promotion program targeted to tobacco quitline callers. METHODS: We surveyed smokers (n = 455) who had recently received tobacco quitline services through their medical insurance. Participants were asked about their self-reported oral health indicators, key behavioral risk factors for oral disease, motivation for changing their oral self-care behavior, and interest in future oral health promotion services. Where applicable, results were compared against those from a representative sample of callers to a free, state-funded quitline (n = 816) in the same geographic region. RESULTS: Callers to a commercially-funded quitline had higher socioeconomic status, were more likely to have dental insurance, and reported better overall oral health indicators and routine self-care (oral hygiene, dental visits) than callers to a state-funded quitline. Nevertheless opportunities for oral health promotion were identified. Nearly 80% of commercial quitline callers failed to meet basic daily hygiene recommendations, 32.8% had not visited the dentist in more than a year, and 63.3% reported daily alcohol consumption (which reacts synergistically with tobacco to increase oral cancer risk). Nearly half (44%) were interested in learning how to improve their oral health status and, on average, moderately high levels of motivation for oral health care were reported. Many participants also had dental insurance, eliminating an important barrier to professional dental care. CONCLUSIONS: Future public oral health promotion efforts should focus on callers to both free state-supported and commercially-funded tobacco quitlines. While differences exist between these populations, both groups report behavioral risk factors for oral disease which represent important targets for intervention.

Understanding oral health promotion needs and opportunities of tobacco quitline callers.

OBJECTIVE: Improving oral health and oral health care are important public health goals. Tobacco users and smokers are at particularly high risk for oral disease and warrant targeted intervention efforts. We assessed the need for and acceptability of targeting tobacco quitline callers for an oral health promotion intervention. METHODS: We surveyed 816 Washington State Quitline callers to assess their oral health, relevant self-care behaviors, and interest in oral health promotion intervention. RESULTS: Most respondents were female, cigarette smokers, of low socioeconomic status, with no dental insurance. Of the respondents, 79.3% (n=647) had some or all of their natural teeth (e.g., dentate); however, most of these respondents failed to meet recommendations for daily oral hygiene (brushing and flossing) (83.9%, n=543) and had no dental visits in the past year (52.6%, n=340). Similar findings were observed among respondents with no insurance. Many respondents were interested in learning more about how to improve their oral health (57.4%, n=468), willing to speak with a quitline coach about improving their oral health (48.2%, n=393), and open to receiving additional oral health information by mail (62.7%, n=512) or the Internet (50.0%, n=408). People who were receptive to learning how to improve their oral health were significantly more likely to be nonwhite, have a low income, have no dental insurance, and not have visited a dentist in the past year. CONCLUSION: There is a need and an opportunity to target quitline callers for oral health promotion services, as those most in need of these services were open to receiving them.

Cost-effectiveness of varenicline and three different behavioral treatment formats for smoking cessation.

There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n=401), PTC (n=402), or combined PTC-Web counseling (n=399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.

Engagement and retention: measuring breadth and depth of participant use of an online intervention.

BACKGROUND: The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements. OBJECTIVE: The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables. METHODS: Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake. RESULTS: Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001). CONCLUSIONS: By exploring participants' exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions. TRIAL REGISTRATION: NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty).

Cost analyses of a web-based behavioral intervention to enhance fruit and vegetable consumption.

BACKGROUND: The purpose of this paper is to evaluate costs associated with the online intervention trial, Making Effective Nutritional Choices for Cancer Prevention (MENU), and to connect the findings to the study outcomes. METHODS: Using prospective data collected during the MENU development and implementation phases, we estimated overall costs per person, incremental costs for the three arms of the MENU intervention, and incremental costs per change in fruit and vegetable (F&V) consumption across the studied population. The MENU study was conducted in five HMO sites of the Cancer Research Network. The number of eligible study participants who were enrolled in the study was 2,540. Recruited participants were randomized into (1) an untailored website program, (2) tailored website program, or (3) tailored web program plus personalized counseling (HOBI) via email. The primary measures for these analyses include the total intervention costs, average cost per participant, and the average cost per mean change in daily intake of F&V, stratified by study arm. RESULTS: The mean change in F&V consumption was greater in both the tailored arm and statistically higher in the HOBI arm relative to the untailored arm. The untailored arm achieved +2.34 servings increase vs. the tailored website arm (+2.68) and the HOBI arm (+2.80) servings increase. Total intervention costs for MENU participants who completed the 12-month follow-up assessment, by study arm, were estimated to be $197,197 or $110 respectively. This translates to $69 per participant in the untailored web site intervention, $81 per participant in the tailored website intervention, and $184 per participant in the HOBI intervention and a cost per average change in F&V consumption to be $35, $27 and $61 respectively. CONCLUSIONS: Providing personalized "tailored" messages and additional personalized support via email generated an additional $12-$115 per participant, over the untailored web program. Incremental increases in F&V consumption associated with the email support arm were associated with considerable increases in intervention costs, suggesting that the most cost effective arm of the MENU study by servings gained was the tailored website.

Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants.

BACKGROUND: Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll. OBJECTIVE: The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ. METHODS: The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment. RESULTS: Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame. CONCLUSIONS: Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU).

Immediate and short-term impact of a brief motivational smoking intervention using a biomedical risk assessment: the Get PHIT trial.

INTRODUCTION: Providing smokers with biologically based evidence of smoking-related disease risk or physical impairment may be an effective way to motivate cessation. METHODS: Smokers were recruited for a free health risk assessment and randomized to receive personally tailored feedback based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions or generic information about the risks of smoking and personalized counseling based on their diet, body mass index, and physical activity. All (n = 536) were advised to quit smoking and offered access to a free telephone cessation program. Participants were surveyed immediately after intervention and 1 month later to assess the impact on various indices of motivation to quit. RESULTS: Immediately posttreatment, experimental participants rated themselves as more likely to try to quit (p = .02) and reported a greater mean increase in their motivation to quit than controls (p = .04). At 1-month follow-up, however, we found no significant group differences on any motivational indices. In post-hoc analyses comparing smokers in the experimental group with and without lung impairment, persons with impaired lung functioning had a greater change from baseline in posttreatment motivation to quit (adjusted p = .05) and perceived risk of developing a smoking-related disease (p = .03) compared with persons with no lung impairment, but we found no significant treatment effect on any motivational indices at 1 month. DISCUSSION: The results suggest that the intervention had a small, temporary effect, but we found no clear evidence that the intervention increased motivation to quit smoking during the first month postintervention.

Nicotine patches and uninsured quitline callers. A randomized trial of two versus eight weeks.

BACKGROUND: State-level tobacco quitlines are integrating nicotine replacement therapy (NRT) into service. Because of funding limitations some provide short courses of NRT. No randomized trial has evaluated the relative benefit of short versus standard treatment. DESIGN: A two-cell randomized trial comparing 2 weeks of NRT to 8 weeks. SETTING/PARTICIPANTS: Uninsured callers to the Oregon Quit Line during a free-patch initiative from October 18, 2004, to May 5, 2005, who were 18 years or older, smoked five or more cigarettes per day, did not have a medical contraindication to NRT use, and were interested in quitting in 30 days. Data were collected from April to November 2005, and analyzed in 2006--2007. INTERVENTION: Participants were eligible for two phone counseling sessions. 1154 participants were randomized to receive via the mail either 2 or 8 weeks of nicotine patches. MEASURES: Primary outcome was self-reported complete abstinence from tobacco for 30 or more days at the 6-month phone survey. Secondary outcomes were 7-day point prevalence and 90-day abstinence, satisfaction, and patch use. ORs and CIs were computed. Cost per quit and incremental cost per additional quit were computed based on program costs. RESULTS: Intent-to-treat 30-day abstinence was 14.3% in the 2-week group, and 19.6% in the 8-week group (OR 1.45 [CI=1.01, 2.12]). Average cost per quit was $1156 for 2 weeks and $1405 for 8 weeks, with an incremental cost effectiveness of $2068. Satisfaction increased from 90% to 97% with 8 weeks. Those receiving 8 weeks of NRT took more calls (2.0 vs 1.6) and used more patches (6.3 weeks vs 4.3 weeks), but were less likely to purchase patches (16.2% vs 39.3%). CONCLUSIONS: Eight weeks of patches improved quit rates compared with 2 weeks, and was cost effective.

Effect of incentives and mailing features on online health program enrollment.

BACKGROUND: With the growing use of Internet-based interventions, strategies are needed to encourage broader participation. This study examined the effects of combinations of monetary incentives and mailing characteristics on enrollment, retention, and cost effectiveness for an online health program. METHODS: In 2004, a recruitment letter was mailed to randomly selected Midwestern integrated health system members aged 21-65 and stratified by gender and race/ethnicity; recipients were randomly pre-assigned to one of 24 combinations of incentives and various mailing characteristics. Enrollment and 3-month retention rates were measured by completion of online surveys. Analysis, completed in 2005, compared enrollment and retention factors using t tests and chi-square tests. Multivariate logistic regression modeling assessed the probability of enrollment and retention. RESULTS: Of 12,289 subjects, 531 (4.3%) enrolled online, ranging from 1% to 11% by incentive combination. Highest enrollment occurred with unconditional incentives, and responses varied by gender. Retention rates ranged from 0% to 100%, with highest retention linked to higher-value incentives. The combination of a $2 bill prepaid incentive and the promise of $20 for retention (10% enrollment and 71% retention) was optimal, considering per-subject recruitment costs ($32 enrollment, $70 retention) and equivalent enrollment by gender and race/ethnicity. CONCLUSIONS: Cash incentives improved enrollment in an online health program. Men and women responded differently to mailing characteristics and incentives. Including a small prepaid monetary incentive ($2 or $5) and revealing the higher promised-retention incentive was cost effective and boosted enrollment.