Increasing access to smoking cessation treatment among Latino smokers using case management

INTRODUCTION

Tobacco use remains the leading preventable cause of disease and death among Latinos, contributing to cancer, heart and lung disease, and stroke¹. Clinical practice guidelines recommend use of brief advice, counseling, and pharmacotherapy to treat tobacco use². These evidence-based therapies are underutilized among Latinos in the United States^3-7. Compared to both African Americans and non-Hispanic Whites, Latinos are less likely to receive advice to quit from healthcare providers^3,4, utilize pharmacotherapy^5,6, and utilize state-funded smoking cessation quitlines⁷. According to the 2015 National Interview Survey, only 16.6% of U.S. Latinos used cessation pharmacotherapy compared to 32.6% of non-Latino whites⁸. Estimates for utilization of counseling services follow a similar trend (5.1% vs 6.9%)⁸.

A number of factors may account for low utilization of smoking cessation resources. Overall, Latinos report a lack of knowledge about smoking cessation treatment options and perceive a lack of cultural sensitivity in the Spanish-language resources available to support smoking cessation^6,9. Many Latinos hold a number of misconceptions about smoking and smoking cessation and may tend to avoid pharmacotherapy, viewing smoking as a weakness, not an addiction^5,10-11.

Nicotine dependence has been conceptualized as a chronic disease involving repeated cycles of quit attempts and relapse¹². For other chronic diseases where patients are not regularly receiving evidence-based care, case management (CM) has been commonly used to support the delivery of care^13-15. CM is one strategy for improving patient care through management of multiple aspects of a patient’s care, including planning and assessment, coordination of services, and patient education¹⁶. The managed care industry, including safety net clinics¹⁷, frequently use case managers to provide behavioral counseling and help patients with chronic diseases coordinate their care^18-20. CM, however, has not been tested as a strategy for reducing the barriers in access to treatment for Latino smokers. The objective of this study was to test the feasibility of a CM approach for overcoming barriers to accessing pharmacotherapy and smoking cessation quitlines for Latino smokers. Therefore, an effective, feasible model for reaching and treating Latino smokers through community venues beyond clinical settings has the potential for immediate widespread adoption. Results from this study will help address tobacco-related disparities among Latinos. This study will add to existing literature by offering a practical method that helps Latinos quit smoking and that can be disseminated into community settings.

METHODS

Study Design

Eighty Latino smokers participated in a randomized, two-arm pilot study. Eligible participants were randomly assigned to the case management (CM, n=40) intervention group or the standard care control group (SC, n=40). All study procedures were approved by the Human Subjects Committee of the University of Kansas Medical Center. This study was not registered as a clinical trial.

Recruitment

Latino smokers were recruited using via two community-based recruitment strategies: 1) Promotoras de Salud (Community Health Workers) recruited participants from venues with a high concentration of Latino including large health events and safety-net clinics, and 2) through telephone outreach using databases of smokers from two community-based organizations and one safety-net clinic.

Participant Eligibility

Eligible participants 1) identified as Latino, 2) were ≥18 years of age, 3) smoked a minimum of five days in the past week, 4) had an active telephone number, and 5) spoke English or Spanish. Individuals were excluded if 1) they were currently participating in a smoking cessation program or taking smoking cessation pharmacotherapy, 2) they were currently pregnant, breast feeding or planning to do so in the following year, 3) they were not considering quitting smoking in the following 30 days, 4) they were planning to move from the area within the next six months, or 5) if they demonstrated mental incapacity to complete the survey. Bilingual (English and Spanish) trained staff determined participant eligibility. Consent forms were mailed to eligible participants’ home and verbal informed consent was provided over the phone.

Randomization

Participants were randomized between June 2011 and March 2012. The study biostatistician (H.W. Y.) prepared sealed envelopes with group assignments, which were randomly ordered. Research staff drew one envelope from this stack to determine whether participants were assigned to CM or SC. Hence, neither the participant nor study staff knew in advance the group assignment of each participant.

Intervention and Control Components

Educational Material:

Participants from both the intervention and control group received the standard care for smoking cessation by mail, which included printed smoking cessation educational materials with information about pharmacotherapy, Pharmaceutical Assistance Programs (PAP), and the state-funded tobacco quitline. These materials were provided in either Spanish or English, depending on the participant’s preferred language. Additionally, the mailing packages included application forms for the GlaxoSmithKline Bridges to Access and Pfizer’s Connection to Care PAP²¹. These programs allow individuals who are uninsured or underinsured free access to either bupropion or varenicline, respectively, if they met the following conditions: being prescribed Pfizer/GlaxoSmithKline pharmacotherapy, reside in the U.S., total gross annual household income at or below two times the federal poverty level adjusted for family size and either no insurance for prescription medicines or having coverage but experiencing financial hardship. The application forms were accompanied by a detailed letter in either English or Spanish that explained the application process. To apply to both programs, participants had to complete the application and provide income documentation and prescription(s) for the medication and mail the complete application to the indicated address. If approved, the applicant would be eligible to receive varenicline or bupropion for up to one year.

Case Management (CM) Phone-Based Protocol:

In addition to the standard care educational materials, CM participants received case management telephone calls at baseline, and weeks one, four, and six. Case managers were master-degree level bilingual research staff with training and experience in treating tobacco dependence. Case managers worked with participants to develop a quit plan and assessed the participant’s unique smoking characteristics and preferences. Although case managers were not offering counseling, they used this information to motivate the individual to call the toll-free quitline number and to help them overcome barriers to pharmacotherapy utilization. A PhD psychologist (L.S.C.) with extensive experience in tobacco cessation research developed the counseling scripts. The psychologist also provided training and ongoing supervision to case managers to ensure they reliably conducted high quality, evidence based case management.

In the first phone call (baseline), the case manager provided education on smoking cessation resources (specifically the quitline and pharmacotherapy options) and motivated participants to utilize these resources. Key decision points included whether or not the participant agreed to a) develop a quit plan, b) use the quitline, and c) use smoking cessation pharmacotherapy. Case managers asked participants how they felt about cessation medications, and provided targeted information in response to the smoker’s questions or concerns. If they were interested in using smoking cessation pharmacotherapy, the case manager helped the participant complete the application to receive pharmacotherapy. Participants not motivated to quit smoking or use cessation resources received a brief motivational interview using Miller & Rollnick’s Motivation and Confidence Readiness rulers²². The Readiness Ruler is a helpful tool that supports motivational interviewing by guiding conversations about personal change. This technique helped the case manager to enhance the participant’s confidence and plan for quitting smoking. If the motivational interview convinced participants to use pharmacotherapy and/or the quitline, the case manager assisted the participant in contacting the quitline and applying for pharmacotherapy.

CM participants received a second call at week 1 for any additional assistance with the pharmaceutical application forms. If they had lost the mailed materials, staff mailed a second copy to them followed by one additional support call. Participants who remained unmotivated to quit smoking received motivational support using smoking cessation resources using a decision matrix technique, in which smokers were invited to explore their “pros” and “cons” for quitting smoking and continuing to smoke²².

The week 4 phone call occurred 1 week after participants were scheduled to receive their medication either from a PAP or from their pharmacy. This call was used to identify any problems in utilizing pharmacotherapy or in making calls with the quitline. Participants who continued not to receive pharmacotherapy or counseling continued to receive the motivational interviewing strategies described above. At the week 6 phone call, the case manager helped the participant solve any additional issues related to accessing or using medications or quitline counseling. CM participants who were not ready to quit smoking continued to receive the motivation interviewing strategies described above.

Retention

Participants received a postcard reminder one week prior to the 6-month follow-up assessment. Participants were mailed a $20 retail store gift card upon completing the baseline survey and a second $20 gift card upon completing the 6-month assessment.

Measures

The baseline telephone assessment included the collection of 1) sociodemographic data (age, gender, education, income, etc.); 2) acculturation measures (years living in the USA and language²³); and 3) smoking-related variables (number of cigarettes smoked per day, stage of change²⁴, nicotine dependence²⁵, etc.)

The 6-month follow-up survey collected data on the primary and secondary outcomes as well as process measures. Primary outcomes included self-reported utilization of any smoking cessation pharmacotherapy and the state quitline. Secondary outcomes included self-reported 7-day point prevalence smoking abstinence. Process measures included the reasons for not using the cessation pharmacotherapy or quitline (quitting smoking immediately after baseline, high cost of pharmacotherapy, difficulty in obtaining pharmacotherapy, not wanting to talk with counselors, and misconceptions about addiction, side effects and efficacy). The 6-month follow-up survey also included specific questions for participants in the CM group. These questions asked about appropriateness of the number and duration of CM calls, whether they would recommend the CM to a friend, general satisfaction, helpfulness of the CM to quit and connecting them to the quitline, and how much the CM influenced their decision to quit.

Sample

A sample size of 80 participants (40 for each of the CM and the SC groups) was calculated to provide 80% power, based on Fisher’s exact test, to confidently detect significantly higher utilization of smoking cessation treatment among the CM compared to the control group (5% type I error rate at 6 months post intervention). The projected utilization of smoking cessation treatment was 4% for the SC group and 25% for the CM group.

Statistical analyses

Means, standard deviations and frequencies were calculated for the sample. Associations between the intervention and control groups on sample characteristics and outcomes were analyzed using χ² tests for categorical variables, using the Fisher test when cells had expected counts less than 5. We report the outcomes of Intention to Treat (ITT) analyses and complete case analysis. In ITT, we assumed all participants lost to follow up at 6 month had not utilized either pharmacotherapy or the quitline and were smokers. In the complete case analysis, missing values in the outcome measure were considered to be missing.

RESULTS

Of 310 identified smokers, 134 were reached by phone and completed screening. Of those screened, 80 (82.5%) were eligible and randomized to either the CM or SC group. Fifty-five (68.8%; CM=28 and SC=27) participants completed the 6-month follow-up survey (Figure 1).

Fig. 1.

Study design flow diagram.

Randomization resulted in similar baseline characteristics between CM and SC groups (Table 1). Participants were on average 42 years old (SD 9.6), and 42.5% (n=34) were female. Most were employed (81.2%; n=65) but less than half had not completed high school (53.7%; n=43), and only 8.7% (n=7) had health insurance. More than half (53.7%; n=43) reported living in the USA for less than 10 years, 61.3% (n=49) reported speaking only in Spanish, and 78.8% (n=63) reported thinking only in Spanish.

Table 1:

Socio-demographic characteristics of the sample

	Total n=80	Case Management n=40	Standard Care Control n=40
Age, Mean (SD)	42.0 (9.6)	42.6 (7.4)	41.4 (10.1)
Women, n (%)	34 (42.5)	20 (50)	14 (35)
Marital Status, n (%)
Married	47 (58.7)	22 (55)	25 (62.5)
Single	18 (22.5)	11 (27.5)	7 (17.5)
Separated	6 (7.5)	2 (5)	4 (10)
Divorced	7 (8.7)	3 (7.5)	4 (10)
Cohabitating	1 (1.2)	1 (2.5)	0 (0)
Level of Education, n (%)
Less than high school graduate	43 (53.7)	21 (52.5)	22 (55)
High school graduate or GED	17 (21.2)	5 (12.5)	12 (30)
Technical school	15 (18.7)	8 (20)	7 (17.5)
College graduate or more	5 (6.2)	4 (10)	1 (2.5)
Employment Status, n (%)
Full-time employment	54 (67.5)	26 (65)	28 (70)
Part-time employment	11 (13.7)	5 (12.5)	6 (15)
Unemployed	15 (18.7)	9 (22.5)	6 (15)
Time living in the U.S., n (%)
Less than 1 year	5 (6.2)	2 (5)	3 (7.5)
1 to less than 5 years	12 (15)	9 (22.5)	3 (7.5)
5 to 10 years	26 (32.5)	11 (27.5)	15 (37.5)
More than 10 years	37 (46.2)	18 (45)	19 (47.5)
Health Insurance, n (%)
Yes	7 (8.7)	3 (7.5)	4 (10)
Speaking language, n (%)
Only Spanish	49 (61.3)	20 (50)	29 (36.2)
Thinking language, n (%)
Only Spanish	63 (78.8)	31 (77.5)	32 (80)
Smoking Pattern, n (%)
1 – 10 CPD	57 (71.2)	26 (65)	31 (77.5)
11 – 20 CPD	21 (26.2)	13 (32.5)	8 (20)
21 or more CPD	2 (2.5)	1 (2.5)	1 (2.5)
Smoke within 30 min of waking up, n (%)	20 (25)	11 (27.5)	9 (22.5)
Considering to quit in next 7 days, n (%)	54 (67.5)	23 (57.5)	31 (77.5)

Most participants (71.2%; n=57) were light smokers (smoked 1-10 cigarettes per day) and had tried to quit in the past year (62.5%; n=50). However, few reported ever using the quitline or individual cessation counseling (5.0%; n=4) and only 11.3% (n=9) had received advice from a healthcare professional to stop smoking in the last year.

Primary and secondary outcomes: utilization of smoking cessation resources (pharmacotherapy and quitline) and self-reported 7-day point prevalence abstinence

Using ITT analysis, CM participants reported higher utilization than SC for both pharmacotherapy (15.0% vs 2.5%; p=.10) and quitline (12.5% vs 5.0%; p=.43) (Table 2), although this finding was not significant. Complete case analysis also found that CM produced higher utilization than SC for pharmacotherapy (21.4% vs 3.7%; p=.10) and quitline (17.8% vs 7.4%; p=.42), although this was not significant.

Table 2:

Six month post-intervention outcomes and process variables

	Total n (%)	Case Management n (%)	Standard Care Control n (%)	p-value
OUTCOME VARIABLES
Use of pharmacotherapy (PP)	7/55 (12.7)	6/28 (21.4)	1/27 (3.7)	0.10*
Use of pharmacotherapy (ITT)	7/80 (8.7)	6/40 (15.0)	1/40 (2.5)	0.10*
Use of quitline (PP)	7/55 (12.7)	5/28 (17.8)	2/27 (7.4)	0.42*
Use of quitline (ITT)	7/80 (8.7)	5/40 (12.5)	2/40 (5.0)	0.43*
7-day point prevalence abstinence (PP)	15/55 (27.2)	8/28 (28.5)	7/27 (25.9)	0.82
7-day point prevalence abstinence (ITT)	15/80 (18.7)	8/40 (20.0)	7/40 (17.5)	0.77
PROCESS VARIABLES
Reasons for not using pharmacotherapy A
They thought it was expensive	29/48 (60.4)	10/22 (45.4)	19/26 (73.0)	0.05
They thought it was hard to access	25/48 (52.0)	11/22 (50.0)	14/26 (53.8)	0.79
They thought it had side effects	30/48 (62.5)	13/22 (59.0)	17/26 (65.3)	0.65
They thought it was not effective to quit smoking	28/48 (58.3)	13/22 (59.0)	15/26 (57.6)	0.92
They thought it was addictive	29/48 (60.4)	13/22 (59.0)	16/26 (61.5)	0.86
They wanted to quit without pharmacotherapy	36/48 (75.0)	16/22 (72.7)	20/26 (76.9)	0.74
They thought obtaining pharmacotherapy would take too long	29/48 (60.4)	12/22 (54.5)	17/26 (65.3)	0.44
They thought obtaining pharmacotherapy required too much paperwork	26/48 (54.1)	10/22 (45.4)	16/26 (61.5)	0.26
Reasons for not using quitline B
The quitline never called back after they contacted them	11/48 (22.9)	4/23 (17.3)	7/25 (28.0)	0.49*
They did not like talking to counselors	11/48 (22.9)	4/23 (17.1)	7/25 (28.0)	0.49*
They were not available when the quitline called	10/48 (20.8)	5/23 (21.7)	5/25 (20.0)	0.88
They did not think counseling is an effective method to quit	12/48 (25.0)	5/23 (21.7)	7/25 (28.0)	0.61
Approval for cessation resources
Applied for pharmaceutical assistance program	8/80 (10.0)	8/40 (20.0)	0/40 (0)	0.005*
Approved by pharmaceutical assistance program	8/8 (100)	8/8 (100)	0/0 (0)	-

Boldface indicates statistical significance (p<0.05)

PP: Per-protocol

ITT: Intent-to treat: none of the missing cases used cessation resources or quit

^A:analysis excludes participants lost to follow-up and those who self-reported using pharmacotherapy

^B:analysis excludes participants lost to follow-up and those who self-reported using the quitline.

^*Fisher’s exact probability test

Self-reported abstinence was similar across the two treatment groups. ITT analysis found abstinence rates of 20.0% vs 17.5% for CM versus SC respectively (p=.77). Abstinence rates were 28.6% vs 25.9% for CM versus SC respectively (p=.82) in the complete case analysis.

Process measures: approval for Pharmaceutical Assistance Programs (PAP) and reasons for not using smoking cessation resources

Twenty percent (n=8) of participants in the CM group applied for PAP; no SC group applied for PAP. This difference was statistically significant (Table 2). It is important to note that all participants who applied for PAP were approved and received the medication. Reasons for not submitting the application were beyond the control of case managers, and included no proof of income and loss of interest in varenicline.

Forty-eight participants reported not using pharmacotherapy at follow-up for multiple reasons (Table 2). Participants in CM compared to SC were significantly less likely to report that pharmacotherapy was expensive (45.4% vs 73.0%; p=.05). There were no significant differences among other reasons for not using pharmacotherapy between the two groups. The most common reasons for not using pharmacotherapy included wanting to quit without pharmacotherapy and fear of side effects.

Forty-eight participants reported not using the quitline at follow-up for multiple reasons (Table 2). Reasons for not using the quitline between the two groups did not differ significantly. Most commons reasons for not utilizing the quitline were that 1) participants thought counseling was an ineffective cessation method; 2) participants reported the quitline never called them back; and 3) participants did not like talking to counselors.

Process measures: retention rates, adherence to CM calls, and satisfaction

Twenty-eight CM participants completed follow-up at 6-months (70% retention). Twenty-seven SC participants completed follow-up at 6-months (67.5% retention). Out of the 40 CM participants, 80.0% completed at least one call, 52.5% completed two calls, 25.0% completed three calls and 17.5% completed four calls. Most CM participants (96.4%) were satisfied with the CM approach. At 6-months follow-up, CM participants thought case managers helped them greatly in the process of quitting smoking (39.2%; n=11), accessing pharmacotherapy (21.4%; n=6), and connecting them with the state quitline (10.7%; n=3).

DISCUSSION

To the best of our knowledge, this is the first study to examine the feasibility of CM as a smoking cessation intervention for Latino smokers. CM resulted in a higher number of participants using pharmacotherapy, the quitline, and 7-day point prevalence abstinence, although these differences were not statistically significant. Significantly fewer CM participants reported thinking pharmacotherapy was too expensive compared to the SC control group. Significantly more SC participants reported thinking that obtaining pharmacotherapy would take too long. These differences may be explained by the assistance of the case manager, who helped participants in the CM intervention group obtain free pharmacotherapy.

The CM appeared to be feasible among Latino smokers. Estimates of the number of completed CM calls are comparable to a previous case management study conducted with mostly non-Latino white rural smokers²⁶. In the current study, the average number of completed CM calls was 1.8 out of four possible calls compared to an average of 2.3 out of six in the prior study. However, there is room for improvement given that the U.S. clinical practice guidelines suggest four or more person-to-person treatment in effectively increasing smoking abstinence rates². In general, the level of satisfaction with the CM was high among Latino smokers, despite different opinions regarding the number and length of the calls. However, 30% of CM participants did not show up at follow-up which might be related with dissatisfaction with CM or its components.

CM increased access to evidence-based cessation treatment by assisting with the completion of PAP forms and quitline referrals. Increasing access to evidence-based cessation interventions among Latinos is important as it alleviates some of the barriers experienced by this population²⁷. Our results suggest that mechanisms accountable for the increased access to pharmacotherapy include reducing barriers related to the cost of medication and complexity of PAP paperwork.

Contrary to other smoking cessation CM trials²⁸, this study was pragmatic as participants were not simply mailed free pharmacotherapy by the study staff, but they had to obtain it in a real world setting (buying them or via PAP). The vast majority of participants in the present study had no health coverage, which is strongly associated with decreased engagement with treatment^26,29. This barrier was partly alleviated by the PAP and quitline assistance in the CM group. The lack of increase in use of resources compared to SC was partly related to misconceptions participants had about cessation resources including perceptions of addictiveness, lack of efficacy, side effects and wanting to quit without pharmacological help. Latinos and other minorities are particularly prone to these sort of misconceptions about cessation resources^5,6,10,30. These results suggest that case management for Latino smokers should put more effort into addressing misconceptions.

Results also suggest that, despite improvements in access to pharmacotherapy and counseling, access to these treatments remained an issue. Half of the participants thought pharmacotherapy was hard to access irrespective of their intervention group. Some participants interested in using the quitline were not available when the quitline called them while others did not like to talk to a counselor. It is important to recognize that this study was conducted in 2011, and participants tended to use the landline or pre-paid phones, in which a minimum credit was needed to make and receive calls. Pharmacotherapy access and use would probably increase if quitlines offered free NRT (not covered by PAP). Previous studies show that providing free NRT and counseling treatment via the state tobacco quitline leads to higher access to NRT increasing quit rates^31-33.

This study has some limitations that should be considered when interpreting the findings. This was a pilot study with a modest sample size (n=80) which decreases the power to detect differences between groups. Retention rates were modest and adherence to CM calls varied widely. Economic factors could account for the low adherence to CM calls. Latino immigrants often work multiple jobs with varying schedules and may not have the freedom to schedule CM sessions or respond to calls at will. They may also experience loss of cellphone service or frequent changes in their phone numbers due to inability to pay. This suggests a need for developing innovative strategies to deliver treatment that specifically target and address the needs and preferences of ethnically diverse individuals participating in smoking cessation treatment. Text messaging-based smoking cessation interventions are a good alternative for providing counseling as the treatment can be delivered at any time without the need to talk to a counselor in real time^34-36. In addition, text message interventions are similar to quitlines regarding their potential for scalability and cost-effectiveness – given that notably less human resources are needed to interact with smokers. Lastly, study outcome measures relied on self-report, which may increase the threat of social desirability bias³⁷. Caution should thus be made when interpreting findings. Biochemical verification is recommended to determine cessation rates within tobacco treatment intervention studies³⁸. Despite these limitations, this study has important strengths. This is the first study that assessed the effectiveness of a case management intervention in increasing access and utilization of pharmacotherapy and tobacco quitlines. Moreover, this is the first CM intervention to be studied among Latinos.

This study showed preliminary evidence that case management increases utilization for both pharmacotherapy and the smoking cessation quitline compared to the SC group. Although these findings were not statistically significant, they suggest a clinically relevant increase in access to pharmacotherapy and quitline use among participants engaged by case managers. Recently, the U.S. government has sponsored large-scale demonstration projects to test the utility of CM to better serve people with low incomes who have chronic conditions^27,39. Given the chronic nature of nicotine dependence¹², a disease management approach is warranted. The present study demonstrates that case managers can be effective for coordinating care and linking Latino smokers with evidence-based treatments for smoking cessation. To enhance engagement, case managers should also explore asynchronous communication strategies such as text messages approaches – which have been shown to be effective for smoking cessation in the general population of smokers^34-36. Recent changes in healthcare finances now provide incentives from practices to address quality metrics (such as smoking cessation), develop “registries” of patients in need of services, and offer CM services to these patients⁴⁰. CM for smoking cessation, such as that in this study, could also be delivered via e-visits or virtual visits⁴¹.

Future CM interventions could further increase pharmacotherapy and tobacco quitline use by incorporating health education to directly address misconceptions about smoking cessation pharmacotherapy. Levinson stressed the idea of implementing cognitive reframing in cessation interventions to clarify, for example, that will-power is not dichotomous and incompatible with pharmacotherapy⁵. Future interventions will need to address myths and misconceptions about pharmacotherapy and quitline to increase favorable attitudes towards their use and therefore increase utilization of evidence-based cessation resources.

Conclusion

CM holds promise as an effective intervention to connect Latino smokers to evidence-based cessation treatment. CM resulted in a higher number of participants using pharmacotherapy and the quitline, although it was not statistically significant. Future CM interventions should identify additional strategies to promote utilization of treatment resources to aid smoking cessation while focusing on addressing misconceptions about treatment and availability.