|July 1, 2010
|March 4, 2014
|March 2014 (final data collection date for primary outcome measure)
|7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between intervention and control patients ("smokers") who report nine months after randomization that they are now quitters (i.e., that they have not smoked for the past seven days but did smoke on enrollment). Self-reported smoking status has established validity when compared with measured serum cotinine levels and yields similar population prevalence estimates.
|Same as current
|Complete list of historical versions of study NCT01156610 on ClinicalTrials.gov Archive Site
- Use of any Tobacco Treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between intervention and control patients who report using any pharmacologic tobacco treatment (NRT replacement, bupropion, varenicline) or any behavioral treatment (state quitline, local tobacco program).
- Use of Community Resources to Facilitate Smoking Cessation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between intervention and control patients who report using community resources.
- Patient Report of Socio-cultural Barriers to Tobacco Cessation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation.
- Quit Attempts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The difference between intervention and control patients who report making one or more quit attempts lasting >= 1 day during the nine months after randomization. An increasing number of quit attempts is related to ultimately quitting smoking. We will also examine difference in the number of quit attempts reported by the intervention and control groups within the nine months after randomization.
|Same as current
|Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
|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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
- Smoking Cessation
|Behavioral: Tobacco Treatment
Comparison of integrated cessation counseling tools with the normal standard of care.
Both the intervention and control clinics will be provided with tools for visit-based "best practices" for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline.
Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).
- Experimental: Integrated Cessation Counseling
IVR System: IVR will be used for two purposes: (1) to facilitate access to treatment for low-SES and minority smokers and (2) perform six-month outcome assessment.
Tobacco Treatment Specialist Calls: A tobacco treatment specialist will make four attempts to contact the patient by phone within 14 days. On contacting the patient, the specialist will screen the patient for readiness to quit, provide brief (10 to 15 minutes) counseling tailored to the patient's readiness to quit, and provide information and support for use of medications that could be or were prescribed and about relevant community resources.
NRT: Patients who do not have a contraindication and smoke > 10 cigarettes per day, will be offered a free 6-week kit of generic nicotine patches (2 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches). Individuals who smoke 5-10 cigarettes/day will be offered a 6-week course, starting with the 14 mg patch. Those with a contraindication will not get NRT.
Intervention: Behavioral: Tobacco Treatment
- Active Comparator: Usual Care
IVR Call: Similar to the initial IVR call for the intervention arms, the initial control arm call will confirm the participant's identify and provide a brief description of the study (obtaining information about health behaviors), with the opportunity for the individual to accept or decline participation. Following this introduction, the IVR script will confirm smoking status. The phone script will collect specific information about current smoking (cigarettes/day), prior quit attempts, and motivation to quit during the next month. No further contact will be made with patients in the control clinics until the outcome assessment call. In the control practices, the IVR machine will also generate a text note documenting the information obtained for the patients' EHR for use by the patient's health care providers as part of their "visit-based" best practices.
Intervention: Behavioral: Tobacco Treatment
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|March 2014 (final data collection date for primary outcome measure)
- Must be 18 years of age or older.
- Must be a current smoker.
- Must receive primary care at one of the participating clinics.
- Must have had a PCP visit within the last month at a participating clinic.
- Must have a working phone number listed in Partner's database.
- Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of < $65,000).
- Must speak English or Spanish.
- Hearing impaired patients who cannot use the telephone.
|18 Years and older (Adult, Senior)
|Contact information is only displayed when the study is recruiting subjects
|Jennifer S. Haas, MD, Brigham and Women's Hospital
|Brigham and Women's Hospital
|Massachusetts General Hospital
||Jennifer Haas, MD, MSPH
||Brigham and Women's Hospital
|Brigham and Women's Hospital