This study assessed 892 patients for eligibility and, after exclusions, randomized 352 patients for final analysis.
eAppendix. Structured Script for Patient Navigators.
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Lasser KE, Quintiliani LM, Truong V, et al. Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial. JAMA Intern Med. 2017;177(12):1798–1807. doi:10.1001/jamainternmed.2017.4372
Does a multicomponent intervention with a patient navigator and financial incentives for biochemically confirmed smoking cessation improve smoking cessation rates at 12 months among underserved adult primary care smokers when compared with an enhancement of usual care alone?
In this randomized clinical trial that included 352 adults, the proportion with biochemically confirmed smoking cessation at 12 months was 11.9% with navigation and incentives vs 2.3% with an enhancement of usual care.
Among smokers at an urban safety-net hospital, navigation and incentives for smoking cessation significantly increased smoking cessation rates.
While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. Few interventions have targeted low socioeconomic status (SES) and minority smokers in primary care settings.
To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers.
Design, Setting, and Participants
For this prospective, unblinded, randomized clinical trial conducted between May 1, 2015, and September 4, 2017, adults 18 years and older who spoke English, smoked 10 or more cigarettes per day in the past week, were contemplating or preparing to quit smoking, and had a primary care clinician were recruited from general internal medicine and family medicine practices at 1 large safety-net hospital in Boston, Massachusetts.
Patients were randomized to a control group that received an enhancement of usual care (n = 175 participants) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care, as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment (n = 177 participants).
Main Outcomes and Measures
The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months.
Among 352 patients who were randomized (mean [SD] age, 50.0 [11.0] years; 191 women [54.3%]; 197 participants who identified as non–Hispanic black [56.0%]; 40 participants who identified as Hispanic of any race [11.4%]), all were included in the intention-to-treat analysis. At 12 months following enrollment, 21 participants [11.9%] in the navigation and incentives group, compared with 4 participants [2.3%] in the control group, had quit smoking (odds ratio, 5.8; 95% CI, 1.9-17.1; number needed to treat, 10.4; P < .001). In prespecified subgroup analyses, the intervention was particularly beneficial for older participants (19 [19.8%] vs 1 [1.0%]; P < .001), women (17 [16.8%] vs 2 [2.2%]; P < .001), participants with household yearly income of $20 000 or less (15 [15.5%] vs 3 [3.1%]; P = .003), and nonwhite participants (21 [15.2%] vs 4 [3.0%]; P < .001).
Conclusions and Relevance
In this study of adult daily smokers at 1 large urban safety-net hospital, patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation.
clinicaltrials.gov Identifier: NCT02351609
Tobacco use is the leading cause of preventable morbidity and mortality in the United States. While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. In 2015, smoking prevalence among persons living below the poverty level (26.1%) was nearly double that of persons living at or above the poverty level (13.9%).1 Smoking prevalence among persons of low socioeconomic status (SES) has remained high, despite population-based interventions such as tobacco price increases and free access to tobacco cessation counseling and medications.
Given that multicomponent interventions have shown the most promise in reducing health disparities,2 we implemented a smoking cessation intervention among smokers at a safety-net hospital that included 2 approaches that have been used to address health disparities: (1) financial incentives; and (2) patient navigation, where a layperson from the community guides individuals through the health care system to receive appropriate services. Research has shown that financial incentives are effective for smoking cessation in an employed population,3 among pregnant and newly postpartum women,4 homeless smokers,5 disadvantaged smokers who attended a tobacco cessation clinic,6 as well as among low-income smokers from the general population.7 While 2 small randomized clinical trials (RCTs)8,9 have demonstrated feasibility and acceptability of patient navigation to promote smoking cessation among disadvantaged smokers, we are unaware of previous efficacy studies. We combined these 2 intervention components, anticipating that incentives would augment smokers’ willingness to connect with a navigator and that the navigator would connect people with treatments through which incentives can work.
In this RCT involving primary care patients at a large urban safety-net hospital, our objective was to evaluate the effect of a multicomponent financial incentives and patient navigation intervention in improving biochemically confirmed smoking cessation at 12 months. We hypothesized that the intervention would increase the likelihood of smoking cessation relative to an enhancement of usual care.
The trial was a prospective, unblinded, RCT conducted from May 1, 2015, to September 4, 2017 (12-month follow-up data are presented) for low-SES and minority daily smokers receiving primary care at Boston Medical Center, a large urban safety-net hospital. The trial protocol is available in Supplement 1.10 Through stratified randomization, participants were assigned to 1 of 2 groups. Enhanced traditional care control participants received a low literacy smoking cessation brochure11 and a list of hospital and community resources for smoking cessation. Intervention participants received the same materials; in addition, they received up to 4 hours of patient navigation delivered over 6 months, and financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment. We randomized participants using a random number generator with allocation concealment to a research assistant using sealed envelopes. Randomization was stratified by stage of change (contemplation vs preparation) with regard to smoking cessation. The primary outcome was biochemically confirmed smoking cessation at 12 months.
The institutional review board (IRB) of the Boston University Medical Campus approved the trial, and written informed consent was obtained from all participants. The IRB advised that the exact dollar amount of the incentives not be noted in the informed consent owing to concerns about (1) retention in the control arm; (2) enrollment of “professional subjects”; and (3) potential coercion among low SES participants. Owing to concerns that the efficacy of the incentives was reduced by this approach, the study team obtained IRB approval to disclose the exact dollar amount of the incentives to intervention participants midway through the trial. Therefore, at the 6-month assessment, only some patients were aware of the exact dollar amount of the incentives. At the 12-month assessment, all intervention participants had been notified of the exact dollar amount of the incentives.
Recruitment took place May 2015 through March 2016 in Boston Medical Center’s adult primary care waiting rooms. In addition, potentially eligible individuals identified in the primary care practice’s patient registry received letters inviting them to participate in the study, with an opportunity to opt out of further study contact. Individuals who did not opt out received recruitment phone calls from a research assistant. Eligibility criteria included age of 18 years or older; smoking 10 or more cigarettes per day in the past week; contemplation or preparation stage of readiness to quit smoking; having a primary care clinician in the Section of General Internal Medicine or Department of Family Medicine; having telephone access; speaking English; and being able and willing to participate in the study protocol and provide informed consent. We excluded individuals who were actively using evidence-based smoking cessation treatment. In addition, we excluded Spanish-speaking patients as only 7% of adult primary care patients at Boston Medical Center speak Spanish.
The Social Contextual Model12 guided the interventions. The model presents aspects of the participants’ social context, such as stress, financial problems, social networks, and multiple family roles that influence how population characteristics (race/ethnicity and SES) might affect behavior patterns. Incorporating social contextual factors into intervention design has been shown to promote behavior change among racial/ethnic minority groups.13 The theory of operant conditioning,14 changing behavior by the use of reinforcement which is given after the desired response, guided the financial incentives intervention component.
In addition to traditional care, which consists of assessment of smoking status and brief cessation counseling, participants in this group received a low–literacy smoking cessation brochure11 and a list of hospital and community resources for smoking cessation. Patient navigators did not interact with participants assigned to this group.
Participants in this group received the same materials as participants in the enhanced traditional care group. In addition, they were eligible to receive up to 4 hours of patient navigation delivered over 6 months. Two patient navigators received 10 hours of training in motivational interviewing techniques,15 including use of a structured script (eAppendix in Supplement 2) and promotion of smoking cessation in underserved patient populations. One navigator had completed some college, had worked as a navigator in 3 previous trials of patient navigation,8,16,17 and had served as a community health worker. The other navigator had a bachelor’s degree in human services and had previously worked as a community health advocate and as an outreach coordinator for Boston’s Mayor’s Health Line. After enrollment, patient navigators contacted participants either to talk by phone or to arrange an in-person meeting. We did not designate a specific number of calls or meetings, but allotted a goal of 4 hours of patient navigation time per patient. The navigators identified and discussed salient social contextual factors using motivational interviewing techniques.15 Among participants ready to quit smoking, the navigators directly connected patients to existing yet underused smoking cessation resources such as the Massachusetts quit line and the hospital-based smoking cessation group. The navigators also discussed medications; for participants interested in using bupropion or varenicline, the navigators helped to arrange follow-up with the participant’s primary care clinician. For participants who desired nicotine replacement therapy (NRT), the navigator prompted the study physician (K.E.L.) to send prescriptions to the participants’ pharmacies through the electronic health record (EHR). While not formally trained as tobacco treatment specialists, the navigators delivered some smoking cessation-related counseling. We defined the minimum navigation intervention dose as completion of the script incorporating motivational interviewing techniques, by telephone or in person.
A research assistant provided financial incentives following assessments and biochemically confirmed cessation. The distribution of incentives follows those in a previous study3: $250 for smoking cessation 6 months after study enrollment, as confirmed by a salivary cotinine, and an additional $500 for an additional 6 months after the initial cessation (12-month time point), confirmed by a salivary cotinine. Participants who did not quit smoking at 6 months and who had been unaware of the exact dollar amount of the incentive were given a “second chance” to quit smoking and earn $250 at 12 months, having been notified of the exact amount of the incentive. Study staff distributed incentives to patients who successfully quit smoking by providing a debit card loaded with the incentive amount.
During the intervention, 2 study investigators (K.E.L. and L.M.Q.) met weekly with the navigators to discuss their case load and to review their use of motivational interviewing techniques. We listened to audiotapes of navigation sessions and provided feedback on use of reflections and open-ended questions, and whether the navigators conveyed empathy and interacted with participants in a nonjudgmental manner.
The primary outcome was biochemically confirmed smoking cessation at 12 months. A research assistant, unblinded to study group assignment, attempted to contact all participants by telephone 6 and 12 months after enrollment, and asked whether they had stopped smoking. Participants who reported complete abstinence (not even a puff of a cigarette) for at least 7 days before being contacted during any follow-up interview were asked to come to the hospital to provide a saliva or urine sample for confirmation of smoking cessation with use of a cotinine (half-life, 17 hours)18 or anabasine test (2 week detection window),19 respectively. We considered a cotinine level of 10 ng/mL or less to indicate smoking cessation.20 Among participants who were taking NRT, we considered an anabasine level of less than 3 ng/mL to indicate smoking cessation.21 As smokers, we categorized all patients who self-reported abstinence, but were identified as smokers via biochemical validation; self-reported abstinence but refused biochemical verification; or could not be located. Participants in both study arms received $15 and $20, respectively, for completing each of the assessments. After each interview, participants in both study arms who reported that they had stopped smoking received an additional $15 for submitting a sample for biochemical verification.
We obtained data on receipt of medications for smoking cessation (NRT, bupropion, and varenicline) and attendance at the hospital smoking cessation group via manual chart review. For all participants who were biochemically confirmed quit at 12 months, we reviewed all office visit notes to their primary care clinician for the 6 months following the date of their 12-month assessment, as well as the medical problem list, to ascertain documentation of current smoking. Finally, we obtained data from the Massachusetts Department of Public Health on participant use of the Massachusetts telephone quit line.
We assessed the following sociodemographic variables at baseline: age, sex, marital status, insurance, income, education, employment, and racial/ethnic group. We measured levels of nicotine dependence with the Fagerström Test for Nicotine Dependence22 and interest in quitting, as measured by stage of readiness to quit smoking.23 We used validated measures of stress (the 4-item Perceived Stress Scale),24 chaos (a 6-item Chaos Scale),25 and hassles (the 9-item Abbreviated Hassles Index)26 to assess life circumstances that may be barriers to cessation.
We estimated that at 12 months, 5% of participants in the enhanced traditional care study arm would quit smoking, relative to 20% of participants in the navigation and incentives study arm. We based these estimates on data from prior smoking cessation studies that included low SES adult smokers.9,27 We recruited 175 smokers in the enhanced traditional care control arm and 177 smokers in the navigation and incentives arm, with 88% power to detect a 5% vs 20% difference in cessation rates between the 2 groups, with a 2-sided α of 0.05.
The primary analysis was an intention-to-treat analysis of the difference in the likelihood of biochemically confirmed cessation between the enhanced traditional care control and navigation and incentives groups at 12 months. The similarity of the study groups with respect to covariates at baseline was analyzed by the χ2 test for categorical variables and the Student t test for continuous variables. We used multivariable logistic regression to control for potential confounders identified in bivariable analyses as well as variables of a priori clinical significance28,29 (sex, age, race/ethnicity, income, education, and receipt of an NRT prescription). Because few patients quit smoking in either study arm, we evaluated the adjusted models by including only 2 parameters in addition to the intervention group variable. We examined the effect of the intervention variable, and controlling for age, then each of the additional variables as a third variable.
We expected the majority of missing data to be due to moving or failure to remain in the study. We investigated whether missing data was associated with patient characteristics. We analyzed Pearson correlation coefficients to identify collinearity among variables in the model; the correlation between variables ranged from −0.16 to 0.17 suggesting the absence of collinearity. Variance inflation factors for the predictors were all below 1.5, also suggesting no evidence of collinearity in the regression model. All analyses were conducted using SAS version 9.1 (SAS Institute Inc).
This study assessed 892 patients for eligibility and randomized 352. The Figure shows reasons for exclusion, randomization, and follow-up, and Table 1 shows descriptive characteristics for the enhanced traditional care control and navigation and financial incentives groups. The 2 groups were not different in demographic and smoking characteristics. The majority reported belonging to a racial/ethnic minority group, having low income (≤$20 000/y), and low educational attainment (high school graduate or less). Participants smoked a mean of 15 cigarettes per day. Fifty-two participants in the navigation and incentives group (29.4%) were lost to follow-up or withdrew in the first 6 months, relative to 32 participants in the control group (18.3%) (P = .01). Participants lost to follow-up at 6 months were more likely to be male or white. At 12 months, 48 participants (27.1%) and 53 participants (30.3%) were lost to follow-up in the navigation and incentives group and the enhanced traditional care control group, respectively (P = .51). Participants who were lost to follow-up at 12 months were younger and more likely to be male than patients who were retained.
Few participants in either study arm used the hospital smoking cessation group or the telephone quit line. Participants in the intervention group were more likely to receive prescriptions for NRT. The 6-month cessation rate, as confirmed by cotinine testing, was 9.6% in the navigation and incentives group compared with 0.6% in the control group (P < .001) (Table 2). Participants who were and were not aware of the exact dollar amount of the incentives had similar rates of biochemically verified cessation (10.4% and 8.6%, respectively; P = .69).
Within the intervention group, navigators were unable to contact 25 participants (14%); the navigators contacted an additional 25 participants (14%) but were unable to engage the participant in a discussion about smoking. For an additional 35 participants (20%), the navigators met the participant in person or provided navigation by phone but were not able to complete the motivational interviewing script. Thus, 93 participants (52%) received the minimum navigation intervention dose. Members of the navigation and incentives group who received the minimum navigation intervention dose had significantly higher rates of cessation at 6 months (n = 15 [16.1%]) than those who did not receive the minimum dose (n = 2 [2.4%]) (P ≤ .001). The navigators prompted the study physician to send a prescription for nicotine replacement therapy to the participants’ pharmacy for 60 participants (34%). Five percent of intervention participants attended a hospital-based smoking cessation group or had a visit with a smoking cessation counselor.
At the 12-month assessment, 21 participants (11.9%) of participants in the navigation and incentives group compared with 4 participants (2.3%) in the control group, had quit smoking based on biochemical verification (P ≤ .001). Members of the navigation and incentives group who received the minimum navigation intervention dose had significantly higher rates of cessation at 12 months (n = 17 [18.3%]) than participants who did not receive the minimum dose (n = 4 [4.8%] (P ≤ .001). Eighty-one percent of participants in the intervention arm who quit smoking at 12 months received the minimum navigation intervention dose. Seven of 25 participants (28%) who had biochemically validated abstinence at 12 months had a note regarding current smoking on medical record review. By study arm, 5 of 21 intervention participants (23.8%) had documentation of current smoking relative to 2 of 4 (50%) of control participants (P = .29). Twelve participants (7%) in the navigation and incentives group were abstinent at both the 6-month and 12-month assessments, relative to 0% of the control participants (P ≤ .001).
Stratified analyses demonstrated that the navigation and incentives intervention was particularly beneficial for older participants, women, nonwhite participants, those with the lowest incomes, non–heavy smokers, and those in the contemplation stage with respect to smoking cessation (Table 3).
The odds ratio (OR) for quitting at 12 months was significantly higher in the navigation and incentives group than in the control group in the unadjusted model (OR, 5.76; 95% CI, 1.93-17.13). In the adjusted models, older participants, women, and those who had NRT prescribed had an increased odds of quitting at 12 months (Table 4). The average dollar amount per participant that was paid out for smoking cessation was $480.77.
A multicomponent intervention combining patient navigation and financial incentives substantially increased rates of biochemically confirmed smoking cessation at 12 months among minority and low-SES primary care smokers served by a large, urban safety-net hospital. Our study extends the work of Kendzor et al,6 who demonstrated the short-term effect of offering small financial incentives for biochemically verified abstinence. Like Kendzor et al,6 we found that the intervention was particularly effective among women. Kendzor et al6 focused on patients who attended a tobacco cessation clinic at a safety-net hospital, while our study included a broader group of primary care smokers not already in treatment. The patient navigation component of our intervention was similar to a telephone counseling intervention implemented by Haas et al30 among low SES primary care smokers. As was the case in our study, Haas et al30 included counselling and referrals to community resources to address sociocontextual mediators of tobacco use. However, Haas et al30 did not provide biochemical verification of abstinence.
We were struck that not a single white smoker in our study quit smoking in either study arm. This observation is concerning, especially given the recently documented increase in midlife morbidity and mortality among white non-Hispanic women and men in the United States.31 There are several possible explanations for this finding. First, neither of the patient navigators was white. Others have shown that patient-navigator race concordance improves care after cancer screening abnormalities are detected.32 Second, racial differences exist in the rate of nicotine metabolism, with African-American individuals, on average, having a slower rate of nicotine metabolism compared with white individuals.33 Studies have shown that slow metabolizers of nicotine should use transdermal nicotine, while fast metabolizers should use varenicline.34 Given that our navigators were most easily able to access nicotine replacement therapy for study participants, white smokers, who may have benefited from varenicline, were at a disadvantage.
It is remarkable that so many participants in the intervention arm quit smoking, given that so few used medications to quit. By using a medication to quit smoking, individuals are 2 to 3 times more likely to quit smoking.35-37 Multiple studies have demonstrated underutilization of pharmacotherapy and enduring misconceptions about pharmacotherapy, particularly among black smokers.8,38 We had anticipated that a patient navigator, as a layperson from the participants’ community, might be able to address these misconceptions. The fact that 1 of 3 of intervention participants had a prescription for NRT sent to their pharmacy suggests that the navigators were successful with regard to NRT. At the time of the intervention, the EAGLES trial,39 which showed no significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo, had not yet been published. Future patient navigation interventions could focus on linking more patients to varenicline therapy, particularly white smokers. Similarly, very few participants referred to smoking cessation counseling resources actually used those services. In future iterations, patient navigators should be trained as bona fide smoking cessation counselors so that they may provide cessation counseling to patients during their contacts.
This study had several limitations. It is unclear whether abstinence at either of the 2 assessment points was transient or long lasting. Our findings may not be generalizable to safety-net settings with large numbers of uninsured smokers. In our study, the majority of participants had Medicaid, which covers nicotine replacement therapy. Our study is also limited by the fact that we cannot discern the relative contribution of the intervention components. Given that 81% of participants in the intervention arm who quit smoking at 12 months received the minimum navigation intervention dose, we believe that the navigation component was necessary. At the same time, we suspect that navigation alone would have been insufficient to achieve the smoking cessation rates we observed. Patient navigation has been shown to help patients achieve discrete, short-term behavior change (eg, completing a colonoscopy)16 yet may be less effective in promoting complex behavior change as is required to quit smoking. This study also had a number of strengths. These included use of biochemical verification of self-reported abstinence and targeting a population of primary care smokers who were not already in treatment, hence testing the intervention on a broader, non–treatment-seeking population of smokers.
This study shows that smoking cessation rates among adult daily smokers at a safety-net hospital who received patient navigation and financial incentives to quit smoking were significantly higher than the rates among smokers who were given program information but no navigation and financial incentives. Future research should assess how the effectiveness of this intervention can be maximized and how health care systems can implement patient navigation and incentives into primary care.40,41
Corresponding Author: Karen E. Lasser, MD, MPH, Section of General Internal Medicine, 801 Massachusetts Ave, Room 2094, Boston, MA 02118 (firstname.lastname@example.org).
Accepted for Publication: August 27, 2017.
Published Online: October 30, 2017. doi:10.1001/jamainternmed.2017.4372
Author Contributions: Dr Lasser had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Lasser, Quintiliani, Truong, Xuan.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Lasser, Quintiliani, Truong.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Lasser, Truong, Xuan, Jean.
Obtained funding: Lasser, Quintiliani.
Administrative, technical, or material support: Quintiliani, Truong, Murillo.
Study supervision: Quintiliani, Truong
Conflict of Interest Disclosures: Dr Quintiliani was a consultant on a research grant to Partners HealthCare Inc unrelated to the work presented in this article. No other conflicts are reported.
Funding/Support: This study was supported by American Cancer Society (grant No. 125785-RSG-14-034-01CPPB).
Role of the Funder/Sponsor: The funder/sponsor 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.
Meeting Presentation: Part of this work was presented at the Society for General Internal Medicine; Washington, DC; April 20, 2017.
Additional Contributions: We would like to acknowledge Scott Halpern, MD, PhD, who advised us on issues related to the financial incentives in the study. We would also like to acknowledge Anna Landau MPH and Glory Song MPH from the Massachusetts Department of Public Health for their assistance in obtaining data on participants’ utilization of the Massachusetts quit line.
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