Smoking Cessation Clinical Trial
Official title:
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
The objectives of this project are to develop and evaluate a multi-level approach to tobacco
treatment for low-SES and minority patients. The components of this intervention would
include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco
treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and
integration of this program with both an individual's primary care physician through an
electronic health record (EHR), as well as referral to community resources to address the
socio-contextual barriers to tobacco cessation. To achieve these objectives, this
intervention will test an innovative model of systematic outreach to low-SES and minority
smokers using systematic phone outreach (including cell phones which are particularly
prevalent among minority and low-SES groups), coordinated with the PCP, using both a
cost-effective technology and a dedicated tobacco treatment specialist to increase smoking
cessation in these populations. The proposed intervention will have multiple levels of
influence (patient, PCP) and provide linkages to community resources. If successful, this
model could be generalized to other health systems with an EHR, which are increasingly being
promoted to improve the safety and quality of health care.
Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment
program for low-SES and minority smokers can reach these patients to increase quit rates and
use of tobacco treatment effectively.
Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized
treatment program for low-SES and minority smokers can be adopted across a variety of
practice settings and be consistently implemented across diverse patient populations.
Because 70% of smokers have seen a PCP within the past year, primary care represents a
valuable platform for reducing disparities in tobacco use that could be made more effective.
The current national focus on expanding the use of EHRs also makes the proposed model to
identify smokers with the goal of reducing disparities in tobacco use particularly timely.
The adoption of EHRs in practices serving minorities is similar to that in all practices,
suggesting that there is not a "digital divide" for PCP practices. In addition, the proposed
intervention is novel because it addresses tobacco use at multiple levels (i.e., individual,
health care setting, community), and is designed to provide smokers with tools to address
socio-contextual contributors to disparities in tobacco use. Finally, the intervention will
be informed by a broad approach using community resources for tobacco cessation. Conceptual
models and empiric data suggest that this type of broad approach is needed to reach low-SES
and minority smokers to reduce disparities in tobacco use. Telephone outreach may be
particularly effective for minority and low-SES populations because cell phone penetration
is higher in these populations. While disparities in tobacco use are rooted in social and
economic problems that extend beyond the domain of health care and traditional treatment
models, the health care system still represents a critical opportunity to initiate
intervention.
Although smoking has declined over the past decades, substantial socioeconomic disparities
in smoking prevalence, risk of addiction, and tobacco-related disease remain in the US,
particularly among different racial, ethnic, and socioeconomic groups. Despite relatively
similar rates of tobacco use, for example, African Americans (a term used interchangeably
with "blacks" throughout this proposal) suffer from a higher burden of tobacco-related
disease, particularly lung cancer, than whites. Importantly, low socioeconomic status (SES)
and minority smokers also have a relatively more difficult time quitting for several
reasons, including more limited access to treatment, misinformation about the risks and
benefits of treatment, more environmental exposure, lack of social support, and other life
stressors.
Primary care physicians (PCPs) are an important source of tobacco treatment, as the majority
of smokers visit a PCP each year. While the US Public Health Service strongly recommends
that clinicians identify and treat every tobacco user, such an approach is largely dependent
on busy clinicians to provide counseling and treatment during a brief visit. Minority and
low-SES smokers are more likely than whites to report that they did not receive counseling
or treatment during a visit. For these reasons it is important to offer systematic
opportunities for tobacco treatment beyond the provider's office, in addition to improving
"best practices" for cessation treatment. Interactive Voice Response (IVR) is a phone
technology that allows a computer to detect voice responses during a normal phone call
(including calls from mobile phones). This technology offers a low-cost, efficient way to
reach out proactively to large populations, independent of a visit. IVR scripts can be
translated into other languages, facilitating systematic outreach to diverse populations.
This technology can provide direct linkage to a tobacco treatment specialist, who can
provide personalized advice for cessation, mood management, and stress reduction, and
provide a course of free nicotine replacement treatment (NRT), as well as linkage to
relevant community resources. Smokers who use NRT as part of their cessation plan are more
likely to succeed than those who do not, and free NRT is a particularly important
intervention for low-SES and minority smokers.
Specific Aim 1: To develop an EHR-linked, IVR-mediated personalized tobacco treatment
program for low-SES and minority smokers. To develop this program, we will first conduct
formative qualitative research to identify the particular barriers to smoking cessation
faced by these populations and subsequently, to create a Community Resource Guide to address
socio-cultural barriers to cessation.
Specific Aim 2: To measure the effectiveness of this personalized treatment program by
conducting a randomized controlled trial of low-SES and minority smokers in 12 clinics from
the Partners Primary Care Practice Based Research Network (PPC-PBRN). Patients in the
intervention group will be offered three contacts with a tobacco treatment specialist over a
12 week period, a free 6-week supply of nicotine patches, and linkage to local resources
using the Community Resource Guide. Patients in the control group will receive visit-based
"best practices" care facilitated by EHR decision support (received by both the intervention
and the control group). The primary outcome of this trial will be the 7-day abstinence rate
at 6 months.
Specific Aim 3: To evaluate facilitators and barriers to the reach, adoption, and
implementation of this personalized tobacco treatment program.
This project fits well with other projects in the Lung Cancer Disparities Center (LCDC),
complementing the other projects that seek to explain disparities in lung cancer at the
molecular, neighborhood, and societal levels. Over 80% of those diagnosed with lung cancer
are current or ex-smokers, supporting the critical importance of smoking cessation to
reducing disparities in lung cancer.1 Our project adds another layer by focusing on the
individual/ clinical interface to reduce disparities in tobacco use.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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