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Multilevel interventions for increasing tobacco cessation at federally qualified health centers (FQHCs)
Investigator (PI): Wetter, David
Performing Organization (PO): (Current): University of Utah Health Care, Huntsman Cancer Institute / (801) 585-0303
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2024
Record Source/Award ID: PCORI/PCS-2017C2-7613
  • HSRR / 1567
Funding: Total Award Amount: $9,523,721
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Problem: Almost one out of every five adults is a smoker, 30% of all cancers are directly attributable to tobacco use, and smoking remains the leading cause of preventable death and disability in the U.S. Fortunately, smoking cessation dramatically decreases the risk of lung cancer, other cancers, cardiovascular and other diseases, and is a cornerstone of chronic disease prevention and control. Moreover, evidence-based smoking cessation treatment is inexpensive and cost-effective. Estimates of cost per life year saved range from $128 to $1450, lower than virtually any other health-related intervention. Furthermore, 70% of current smokers want to quit and over 50% attempt to quit each year. Unfortunately, over 90% of those quit attempts fail, in large part because only about 20% of quit attempts utilize any form of evidence-based treatment. Over the last several decades, smoking has become increasingly concentrated among individuals with low education, living in poverty, and the uninsured and unemployed, and smoking plays a critical role in health disparities, accounting for an astounding 58% of the socioeconomic status (SES) gradient in mortality among U.S. men. Moreover, low SES smokers have greater difficulty quitting, at least in part because of less awareness, access, and use of evidence-based cessation treatments. Federally qualified health centers (FQHCs) are extraordinary venues for reaching low SES populations with evidence-based treatment for tobacco cessation. In 2015, FQHCs provided comprehensive primary care to over 24 million patients, ~60% of whom were minorities and over 70% of whom had incomes less than the federal poverty level. One of the most significant advances in tobacco control over the last several decades has been the creation of tobacco cessation quitlines that are available nationwide. Quitlines provide both behavioral counseling and pharmacotherapy, and the efficacy of quitlines and their potential to reach an extraordinarily large number of tobacco users is extensively documented. Quitlines serve all 50 states as well as Puerto Rico, Guam, and the District of Columbia. Nevertheless, quitlines are grossly underutilized, reaching only about 1-2% of all smokers annually, and even modest increases in their reach could dramatically impact tobacco use prevalence at the population level. Outcomes of the project: The overall objective of this project is to increase the reach and impact of evidence-based tobacco cessation treatment in order to reduce the prevalence of smoking among low SES populations. The scientific premise of the proposed study is based on 1) substantial consensus that evidence-based tobacco cessation treatments delivered via quitlines are effective but grossly underutilized; 2) data demonstrating that electronic health record (EHR)-based interventions at the point of care can dramatically increase the reach of quitline treatment, are feasible, and fit within existing clinical systems; 3) results demonstrating that technology-based approaches such as text messaging can increase the reach of evidence-based treatment; and 4) evidence highlighting the effectiveness of proactive counseling in increasing the reach of and impact of treatment. The proposed study will provide critical data regarding the impact of pragmatic and scalable interventions at both the clinic and patient level that are designed to reduce tobacco use and tobacco-related disparities and advance the field of implementation science by testing key constructs hypothesized to influence implementation effectiveness. The study aims are to evaluate (1) clinic- and patient-level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline). Reach is defined as the proportion of smokers who enroll in quitline-delivered treatment; (2) clinic- and patient-level interventions with respect to increasing the impact of quitline treatment. Impact is defined as reach X efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in quitline-delivered treatment that successfully quit; (3) characteristics of both clinics and patients that may influence smoking outcomes. Our outcomes and assessments represent either our outcomes or potential determinants/moderators of outcomes. The primary outcomes are 1) reach (proportion of tobacco users who enter quitline treatment) and 2) impact (reach X efficacy). For calculating impact, efficacy is defined as the proportion of smokers entering quitline treatment who quit smoking (i.e., achieve abstinence). Abstinence, our primary patient-centered outcome (with health-related quality of life being the other), is used in determining efficacy and will be assessed among all patients at 12 months following study enrollment. The second of our two patient-reported outcomes is health-related quality of life, assessed with the Short Form Health Survey (SF-36), the most widely used quality of life measure. Study design: The proposed project is a multilevel, three-phase, sequential multiple assignment randomized trial (SMART), conducted in 30 FQHC clinics with 6,000 participants. The first phase, clinic-level condition randomizes 30 FQHC clinics to either Ask, Advise, Connect-Opt Out (AAC-Out) or Ask, Advise, Connect-Opt In (AAC-In). AAC-Out consists of an EHR-based point-of-care alert that requires clinic staff to advise and connect smokers to the Utah Quitline, or to "opt out" (i.e., the default requires an action [advise and connect or opt out]). AAC-In consists of an EHR-based point-of-care reminder that allows medical staff to choose when to perform advise and connect (i.e., the default does not require an action). The second phase patient-level intervention is randomized based on prior treatment response. Smokers who do not enroll in quitline treatment in response to AAC-Out or AAC-In will be individually randomized to receive either text messaging (TM) or to continue with the EHR condition only (CO) in a 4:1 ratio (4 to TM for every 1 to CO). TM consists of a monthly text message during the first 6 months following each smoker's clinic visit (i.e., up to 6 texts). Texts include a simple one-touch response that directly connects smokers to the quitline. CO consists of continued clinic-level EHR intervention only following each smoker's clinic visit. In the third phase patient-level condition, non-responders in the TM condition (i.e., did not engage in quitline treatment at 6 months) will be randomized to continued TM (TM-Cont) or continued TM plus MAPS (TM+MAPS). TM-Cont will again consist of monthly text messages that include a simple one-touch response to directly connect to the quitline during months 6-12 following each smoker's clinic visit. TM+MAPS will consist of monthly text messages plus 2 brief telephone calls from patient navigators/health educators during months 6-12 following each smoker's clinic visit. SMART design: We carefully considered alternative study designs, but ultimately settled on a SMART design because it is highly pragmatic, scientifically rigorous, and well suited to address questions of treatment sequencing in order to conserve scarce resources and reduce patient burden. Modifying intensity or type of intervention over time can improve outcomes if an individual is not responding or may reduce costs and patient burden if more resource-intensive treatment is not necessary. As such, the proposed SMART design informs the development of adaptive and stepped care interventions, and the reduction in patient burden is particularly important to ensuring that the interventions are as patient-centered as possible. Although we considered pitting EHR-based approaches, text messaging, and proactive counseling directly against each other, we ultimately decided that the EHR-based approaches are the foundational intervention for proactively connecting primary care to quitlines. As such, we opted to use a SMART design to test the effectiveness of text messaging and proactive counseling over and above the effects of EHR-based interventions, and to further sequence text messaging and proactive counseling based on the resources needed for implementation and maintenance (i.e., testing the effectiveness of proactive counseling over and above the less resource-intensive text messaging approach). This will be the first pragmatic trial to simultaneously test these three empirically supported approaches for linking primary care to quitlines. Quitline treatment: Smokers who engage in treatment will receive standard Utah Quitline treatment protocols. The typical smoker averages 4 completed calls and sessions typically last 20-40 minutes. All smokers who enter treatment are eligible to receive a free 8-week supply of nicotine patch or gum. The number of completed calls and patch/gum use will be tracked by the quitline. The Utah Quitline is providing all treatment at no cost to the patient or to the study. Importance to patients: patient centeredness. Although only 10-20% of smokers are ready to make a quit attempt at any specific moment in time, they are deeply motivated to quit in general and their repeated attempts to quit demonstrate that motivation. As noted previously, 70% of current smokers want to quit and over 50% attempt to quit each year. Moreover, the latter percentage underestimates the proportion of smokers who make a quit attempt each year because that definition requires a 24-hour period of abstinence in order to be labeled a quit attempt, whereas the data indicate that many additional smokers attempt to quit but are unable to muster even a 24-hour period of abstinence. Those smokers unable to quit for even 24 hours are likely to be low SES, highly nicotine dependent, and to have substance abuse and mental health comorbidities. Thus, the vast majority of smokers both want to quit smoking and make a quit attempt each year, but the timing of treatment engagement needs to match their readiness to make a quit attempt. Our proposed program of research is designed to help underserved smokers achieve their goal by increasing their opportunities to engage in evidence-based treatment, as well as the likelihood of successful cessation. Importantly, the patient-level interventions are sensitive to smoker preferences. For example, smokers can opt out of receiving text messages with a single response and can decline to receive a specific call or all calls at any time during MAPS proactive counseling. Similarly, not only are quitline behavioral and pharmacologic treatments evidence-based, but there is also typically some flexibility in the number and timing of counseling calls, type of pharmacotherapy provided, and inclusion of modalities such as internet programs, text messaging, and interactive voice response systems. Thus, patient preferences are integrated into every component of the proposed research. The investigators have been conducting smoking cessation research with incredibly diverse populations (e.g., low SES, African Americans, both English- and Spanish-speaking Latinos on the mainland U.S. and in Puerto Rico, pregnant women, etc.) for over 20 years. We have held numerous focus groups and conducted hundreds of discussions with our participants about their goals, reasons for quitting, and needs during that time. There are two patient-reported outcomes that unwaveringly hold constant as the most important to smokers: achieving abstinence from tobacco and improving their health. As such, we include two patient-reported outcomes that are deeply important to smokers: abstinence and health-related quality of life (the latter measured with the Short Form Health Survey [SF-36]). Closing the gap: Recommendations from the Centers for Disease Control and others include aggressive, targeted, proactive strategies to increase the utilization of quitlines including formal partnerships with primary care. More recently, the National Cancer Institute's (NCI) Tobacco Control Priorities for the Next Decade identified increasing the "reach, demand, quality, dissemination, implementation, and sustainability of evidence-based tobacco use treatment" as priority number 1. The U.S. Preventive Services Task Force "recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and U.S. FDA approved pharmacotherapy for cessation ("A" level evidence)." Moreover, the implementation and dissemination of "evidence-based tobacco control strategies" was identified as a priority recommendation for reducing health disparities by the National Institutes of Health (NIH). Finally, a series of Cochrane reviews, as well as the 2014 update of Evidence for Quitline Practices from the North American Quitline Consortium, have identified EHR system changes, text messaging, and proactive counseling as empirically supported interventions for increasing engagement with evidence-based tobacco cessation treatment delivered by quitlines. In sum, there is considerable consensus around the need to increase the reach and impact of evidence-based tobacco cessation treatment delivered via quitlines among low SES populations. However, the lack of evidence addressing precisely how and when to implement EHR system changes, text messaging, and proactive counseling to increase engagement with quitline treatment represents a major gap undermining the adoption, implementation, and maintenance of these interventions. The proposed research directly addresses Patient-Centered Outcomes Research Institute (PCORI) Priority Topic 7: Multicomponent interventions to reduce initiation of tobacco use and promote cessation of tobacco use among high-risk populations with known disparities. Multilevel interventions (MLIs): MLIs target change in more than one contextual level (e.g., patient, clinic) to influence health behavior, health care, and health outcomes, and MLIs to influence practice change. Thus, the proposed project will implement and evaluate practical, scalable, evidence-based, and recommended intervention strategies targeting two different levels to increase the reach and impact of evidence-based tobacco cessation treatment among patients at 30 FQHC clinics: 1) a clinic-level intervention component that focuses on enhanced system supports at point of care using the EHR; and 2) two patient-level intervention components that both increase opportunities to engage in quitline treatment, as well as provide motivation and practical problem solving strategies for addressing barriers to quitting and treatment engagement. Results from the proposed study have the potential to significantly impact practice change, increase tobacco cessation at the population level, and reduce the disproportionate burden of tobacco-related morbidity and mortality among low SES populations. Adoption into clinical practice and improving delivery of care: Although there is an almost universal recognition of the need to increase the reach and impact of evidence-based tobacco cessation programs in primary care, there are gaps with respect to indicating which implementation alternatives are most effective among clinic-level EHR interventions (e.g., Opt Out vs. Opt In), or whether the addition of patient-level text messaging and proactive counseling improve engagement with quitline treatment among individuals who do not respond to less resource-intensive interventions. The proposed research will provide key guidance on exactly which strategies for implementing the linkage between primary care and quitlines are most effective, as well as whether progressively more resource-intensive strategies (i.e., text messaging, proactive counseling) provide unique, incremental effectiveness over and above the implementation of less resource-intensive approaches (i.e., EHR strategies). The findings will provide critically needed information to health care decision makers and stakeholders, including FQHC CEOs/medical directors, other health care system administrators (i.e., those not specifically focused on underserved populations), state quitline funders, national and state organizations such as the National Association of Community Health Centers, Association for Utah Community Health, and the North American Quitline Consortium, as well as many others. Further, the interventions in the proposed research will be replicable and widely disseminable because of our utilization of a standards-based approach that is required for EHR certification in the U.S., HIPAA (Health Insurance Portability and Accountability Act of 1996)-compliant text messaging services that are increasingly ubiquitous in health care systems, and simple phone counseling that fits exceedingly well with the widespread movement towards integration of behavioral health services into primary care. Importance of the project: We believe the proposed comparative effectiveness trial is important to patients, clinicians, health care systems, funders, and the field of tobacco control as a whole for a number of reasons: (1) it empirically addresses national policy and research priorities related to tobacco control and health disparities. Using a rigorous and innovative study design, the proposed project will evaluate practical, nationally scalable, multilevel interventions to directly address strategic national priorities for reducing tobacco use and tobacco-related disparities by increasing the impact of evidence-based tobacco cessation interventions in low SES populations (Ending the Tobacco Epidemic: Progress Toward a Healthier Nation; Making Cancer Health Disparities History: Report of the Trans-HHS Cancer Health Disparities Progress Review Group; Tobacco Control Priorities for the Next Decade); (2) it advances the science of dissemination and implementation research. The proposed study utilizes a novel, integrated conceptual framework, anchored by social cognitive theory (SCT), the Consolidated Framework for Implementation Research (CFIR), and RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance), that yields meaningful interventions to accelerate the process of real-world change. Intervention mapping (IM) organizes constructs to guide the development of the multilevel interventions; (3) it leverages technology to change primary care clinical practice. Prior research has empirically demonstrated the impressive real-world impact of effectively utilizing health information technology at the point of care (i.e., AAC). The proposed project builds on that impact by directly comparing EHR-based strategies that incorporate key behavioral economic principles into point-of-care alerts, as well as utilizes low-cost, HIPAA-compliant text messaging that can dramatically increase the ability to repeatedly reach smokers with an offer of treatment that includes almost no barriers to treatment engagement (e.g., a simple, one-character response to a text starts the process of treatment engagement); (4) it targets multiple levels of influence in a high-risk population. The National Tobacco Cessation Collaborative Consumer Demand Roundtable included priority recommendations targeting multiple levels, including patients and health care systems. In addition, the critical need to move to multilevel approaches in health care was highlighted at the NCI Conference on Multilevel Interventions in Health Care: Building the Foundation for Future Research, and by tobacco control researchers. The proposed research directly addresses these recommendations through the implementation of multilevel (clinic and patient), multicomponent (EHR, text messaging, proactive counseling) interventions, which directly addresses PCORI Priority Topic 7 regarding multicomponent interventions for addressing high-risk populations such as those served by FQHCs; (5) it has an innovative SMART design and FQHC partners optimize internal and external validity. The incremental effectiveness of specific intervention components and dynamic treatment regimens are evaluated in a rigorous, pragmatic SMART design that maximizes internal validity. In addition, the proposed project is conducted in real-world practice settings that serve a high-risk population (i.e., FQHCs) with minimal disruption to clinical workflow to maximize external validity and the potential for broad scale uptake; and (6) patient-level interventions utilize ubiquitous technology. There is almost no modality with broader reach into low SES populations than the telephone. >92% of households with annual incomes less than $30,000 own a cellphone, 81% of cellphone owners send and receive text messages, and numerous health care systems already utilize text messaging. As such, our intervention modality for both text messaging and proactive counseling rules out a very small proportion of low SES smokers. In one of our current studies focused on low-income smokers, only 0.02% (i.e., substantially <1%) were excluded because they either lacked a home address or a working telephone. Patient and stakeholder partners engagement approach: planning the study. The investigative team has a strong track record of partnering with low-resource health care systems that serve low SES populations. To provide some history, the proposed study grew out of our work over the last 15 years with safety net health care systems (Harris Health in Houston, FQHCs in Houston and Utah), professional organizations (Association for Utah Community Health [AUCH]), and Quitlines (Utah, Texas, Minnesota, Puerto Rico, National Cancer Institute [NCI]). Our initial AAC project was developed in partnership with Harris Health, one of the largest safety net health care systems in the country, after they requested our help in designing a process for ensuring that their patients who smoked had access to evidence-based cessation treatment. After hearing of our work with Harris Health, we were approached by Kelsey Seybold to replicate our AAC work. Results from these two AAC studies are described earlier. Following the completion of the initial AAC study at Harris Health, we worked together with them to design a system to reach those smokers who were not motivated to quit, and hence, did not accept a connection to the quitline. That project utilized proactive counseling (i.e., MAPS) to reach out to unmotivated smokers. All of these studies also partnered with the Texas Quitline. One of our earlier MAPS studies was in partnership with the National Cancer Institute's Cancer Information Service in Texas. That project focused on increasing reach among Spanish-speaking smokers, who had extraordinarily low rates of quitline use. In that study, we were able to increase monthly call volume from Spanish-speaking smokers to the NCI Quitline over 45-fold, and to demonstrate that a precursor of MAPS was effective. Nationally, the team has been involved in two studies to understand the implementation of evidence-based approaches in FQHCs. On a more micro level, we have been holding focus groups and interviewing patients for the last 20 years with respect to their goals and reasons for quitting, and their preferences for treatment. That feedback guided our patient-centered outcomes of abstinence and quality of life, and MAPS has been adapted and refined based on that feedback over the course of a half dozen NIH funded trials. At the time of Drs. Wetter and Lam relocating to Utah in January of 2017, the Utah Quitline was already promoting AAC and cessation was a top strategic priority for AUCH. Based on those priorities, we worked with our stakeholder partners (AUCH, Utah Quitline, and FQHC leaders) to design the proposed research. To engage patients and stakeholders and incorporate their input throughout the entire research process (i.e., planning, conduct, and reporting), a study advisory committee (SAC) of 16 members will be created. The SAC membership will include Dr. David Wetter (PI); Dr. Guilherme Del Fiol (medical informatics expert on the research team); Dr. Hilary Tindle (external expert on quitlines and health care system linkages); one representative each from AUCH, Utah Quitline (Utah Department of Health Tobacco Prevention and Control Program), and the 9 participating FQHCs; and 2 patient representatives. To empower our stakeholders and patients to be active and equal partners, and to foster a true reciprocal relationship between the research team and the stakeholders/patients where all parties have decision making authority, the SAC will be co-chaired by Dr. Wetter and a stakeholder/patient representative. The SAC will espouse PCORI's 6 Engagement Principles--reciprocal relationships, co-learning, partnership, transparency, honesty, and trust as the guiding principles of operation. The SAC will meet bi-annually and will hold at least two meetings during the planning stage of the proposed project (stage 1, approximately 12 months). During the planning stage, the SAC will discuss, identify barriers, refine, and make final decisions on the following research topics/activities: research questions, comparators, outcomes, participant recruitment and consent procedures, data collection procedures, EHR adaption, text messaging content and procedures, MAPS content and procedures, and abstinence and quality-of-life outcomes. The final study protocol will be written based on SAC decisions. Conducting the study: During the conduct stage of the proposed project (stage 2, approximately 36 months), the SAC will ensure that all study procedures are executed as intended and reflect best clinical practices and scientific rigor, and that all milestones are met. For instance, the SAC will review information on participant recruitment, enrollment, and retention, and if necessary, revise procedures to address challenges in these areas. FQHC representatives will be encouraged to report on the research activities at their respective clinics. Input from stakeholders and patient partners will be especially important in addressing procedural challenges faced by providers/health coaches during their contact with participants. The SAC will also review information provided by the Data and Safety Monitoring Board (DSMB) and work closely with the DSMB to address any data and safety concerns. Disseminating the study results: The last 12 months of the project is the reporting stage (stage 3, approximately 12 months), and will be devoted to data analyses, preparation of the draft final research report, and reporting of findings. The biostatistics team (Dr. Greene, statistical analyst, and data manager) will be invited to a SAC meeting to discuss the analytic approach, and the stakeholder/patient partners will share with the biostatistics team their patient-centered perspective on analysis and interpretation of results. Dr. Maria Fernandez will also be invited to the SAC meeting to engage the members in their ideas for reporting and dissemination strategies. Like other stages of the proposed project, stakeholder/patient partners will work alongside research team members to review findings and develop a reporting plan that includes publicizing the projects' findings in academic journals, open-access journals, professional meetings, community and advocacy organizations conferences (e.g., Cancer Prevention And Control Research Network [CPCRN]), health care partners (e.g., Intermountain Health), social and news media, and other lay outlets (e.g., flyers). Patient and stakeholder partners will play a key role in developing the lay summaries of the project results, and in planning for the long-term sustainability of the project. The SAC will meet at least twice a year (one face-to-face meeting and one videoconference), and more if necessary. Before the first SAC meeting, the draft protocol of the proposed study will be shared with the members. Members will receive the agenda of each meeting at least one week before the meeting. Partners can submit agenda items before or after receiving the draft agenda. If a designated partner cannot attend a meeting, they can notify the research team and send another representative from their organization on their behalf. Besides attending the meeting, stakeholder partners are tasked with sharing the meeting discussions and findings with their respective organization, and to solicit feedback and comments on the topics that have been/will be discussed in the meetings. All meetings will be recorded. Meetings will be facilitated by the Center for HOPE (Health Outcomes and Population Equity) at the Huntsman Cancer Institute and the University of Utah. Although the Center for HOPE is new to Utah, it builds on Dr. Wetter's 15 years of expertise and experience at the University of Texas MD Anderson Cancer Center leading the Center for Community-Engaged Translational Research, the NCI-funded Community Networks Program Center, the NIH-funded CTSA Community Engagement component, and the Department of Health Disparities Research. Thus, the Center for HOPE brings expertise in community and patient engagement and will play a crucial role in empowering all partners. All stakeholder/patient SAC members will be equally compensated for their time and travel expenses.
MeSH Terms:
  • Community Health Services
  • Cost Effectiveness
  • Evidence-Based Medicine
  • Female
  • Health Care Disparities
  • Hotlines
  • Humans
  • Interinstitutional Relations
  • Lung Neoplasms /prevention & control
  • Male
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • Poverty
  • Primary Care
  • Program Development
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Reminder Systems
  • Smoking Cessation /economics
  • /*methods
  • Socioeconomic Status
  • Telemedicine
  • Text Messaging
  • Tobacco Use Disorder /*therapy
  • United States
Country: United States
State: Utah
Zip Code: 84112
UI: 20192425
Project Status: Ongoing