AzTrials
AzTrials

SmokingNCT01156610

Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations

A study testing Tobacco Treatment in people with Smoking and Smoking Cessation, run by Brigham and Women's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Smoking Cessation
What is being tested?
Tobacco Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
706 participants
Where
2 sitesUnited States
Study dates
Nov 2011to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Hearing impaired patients who cannot use the telephone.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02110

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Tobacco Treatment
Keywords
Smoking, Smoking Cessation, Electronic Health Record, Telephone
Medical subject headings
Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tobacco TreatmentBehavioural

    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).

Study groups in NCT01156610
Study groupRoleWhat they receive
Integrated Cessation CounselingExperimentalIVR 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.
Receives: Behavioral: Tobacco Treatment
Usual CareActive comparatorIVR 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.
Receives: Behavioral: Tobacco Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization).

    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.

    Measured: 2 years

Secondary outcomes (4)
  1. Use of any Tobacco Treatment

    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).

    Measured: 2 years

  2. Use of Community Resources to Facilitate Smoking Cessation

    The difference between intervention and control patients who report using community resources.

    Measured: 2 years

  3. Patient Report of Socio-cultural Barriers to Tobacco Cessation

    The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation.

    Measured: 2 years

  4. Quit Attempts

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2010 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
706 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01156610
Sponsor's protocol ID
2010P000405
Other IDs
P50CA148596
Status last verified
Mar 2014
First submitted
1 Jul 2010
Last updated
6 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008 May;83(5):584-94. doi: 10.4065/83.5.584.

    PubMed 18452692
  • Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.

    PubMed 15010446
  • Schroeder SA. Shattuck Lecture. We can do better--improving the health of the American people. N Engl J Med. 2007 Sep 20;357(12):1221-8. doi: 10.1056/NEJMsa073350. No abstract available.

    PubMed 17881753
  • Mendez D, Warner KE. Adult cigarette smoking prevalence: declining as expected (not as desired). Am J Public Health. 2004 Feb;94(2):251-2. doi: 10.2105/ajph.94.2.251.

    PubMed 14759934
  • Rigotti NA. Clinical practice. Treatment of tobacco use and dependence. N Engl J Med. 2002 Feb 14;346(7):506-12. doi: 10.1056/NEJMcp012279. No abstract available.

    PubMed 11844853
  • Meara ER, Richards S, Cutler DM. The gap gets bigger: changes in mortality and life expectancy, by education, 1981-2000. Health Aff (Millwood). 2008 Mar-Apr;27(2):350-60. doi: 10.1377/hlthaff.27.2.350.

    PubMed 18332489
  • Haiman CA, Stram DO, Wilkens LR, Pike MC, Kolonel LN, Henderson BE, Le Marchand L. Ethnic and racial differences in the smoking-related risk of lung cancer. N Engl J Med. 2006 Jan 26;354(4):333-42. doi: 10.1056/NEJMoa033250.

    PubMed 16436765
  • Harman J, Graham H, Francis B, Inskip HM; SWS Study Group. Socioeconomic gradients in smoking among young women: A British survey. Soc Sci Med. 2006 Dec;63(11):2791-800. doi: 10.1016/j.socscimed.2006.07.021. Epub 2006 Sep 7.

    PubMed 16962221
  • Gruer L, Hart CL, Gordon DS, Watt GC. Effect of tobacco smoking on survival of men and women by social position: a 28 year cohort study. BMJ. 2009 Feb 17;338:b480. doi: 10.1136/bmj.b480.

    PubMed 19224884
  • Murphy JM, Mahoney MC, Hyland AJ, Higbee C, Cummings KM. Disparity in the use of smoking cessation pharmacotherapy among Medicaid and general population smokers. J Public Health Manag Pract. 2005 Jul-Aug;11(4):341-5. doi: 10.1097/00124784-200507000-00013.

    PubMed 15958934
  • Honjo K, Tsutsumi A, Kawachi I, Kawakami N. What accounts for the relationship between social class and smoking cessation? Results of a path analysis. Soc Sci Med. 2006 Jan;62(2):317-28. doi: 10.1016/j.socscimed.2005.06.011. Epub 2005 Jul 21.

    PubMed 16039765
  • Jaen CR, Cummings KM, Shah D, Aungst W. Patterns of use of a free nicotine patch program for Medicaid and uninsured patients. J Natl Med Assoc. 1997 May;89(5):325-8.

    PubMed 9170833
  • Cummings KM, Hyland A, Giovino GA, Hastrup JL, Bauer JE, Bansal MA. Are smokers adequately informed about the health risks of smoking and medicinal nicotine? Nicotine Tob Res. 2004 Dec;6 Suppl 3:S333-40. doi: 10.1080/14622200412331320734.

    PubMed 15799596
  • Lee D, Turner N, Burns J, Lee T. Tobacco use and low-income African Americans: policy implications. Addict Behav. 2007 Feb;32(2):332-41. doi: 10.1016/j.addbeh.2006.05.002. Epub 2006 Jul 7.

    PubMed 16828978
  • Graham AL, Papandonatos GD, DePue JD, Pinto BM, Borrelli B, Neighbors CJ, Niaura R, Buka SL, Abrams DB. Lifetime characteristics of participants and non-participants in a smoking cessation trial: implications for external validity and public health impact. Ann Behav Med. 2008 Jun;35(3):295-307. doi: 10.1007/s12160-008-9031-1. Epub 2008 Apr 15.

    PubMed 18414962

Questions about this trial

What is this clinical trial studying?

A study testing Tobacco Treatment in people with Smoking and Smoking Cessation, run by Brigham and Women's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01156610, which also lists 135 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in