AzTrials
AzTrials

Smoking CessationNCT02351609

Patient Navigation and Financial Incentives to Promote Smoking Cessation

A study testing Intervention in people with Smoking Cessation, run by Boston Medical Center at 1 site 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

Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden, smoking rates must be reduced among populations where smoking is disproportionately concentrated: those with low socioeconomic status (SES). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
1 May 2015to 1 Oct 2017
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

  • age ≥ 18; (2) smoked ≥10 cigarettes/day in the past week; (3) have a scheduled visit with a PCP at BMC on the day of enrollment or within the next six months; (4) telephone access (5) English speaking; (6) plan on quitting smoking within the next six months; (7) able and willing to participate in the study protocol and provide informed consent.

Who cannot join

  • planning to move out of the area within the next six months; (2) cognitive impairments that preclude participation in study activities; (3) severe illness or distress; (4) inability to read/understand English; (5) actively using evidence-based smoking cessation treatment; (6) transient residence or lack of a telephone for follow-up assessments.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden, smoking rates must be reduced among populations where smoking is disproportionately concentrated: those with low socioeconomic status (SES). The investigators will apply two methods that are being used in the field of health disparities to the challenge of promoting smoking cessation among low SES smokers. These include: 1) Patient navigation; patient navigators are often lay persons, working as paid employees, who guide patients through the health care system and 2) Financial incentives; investigators propose to provide monetary incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for an additional 6 months of abstinence after the initial cessation. The investigators will recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced Traditional Care control condition (smoking cessation brochure/list of cessation resources). The RCT will take place among adult daily smokers seen in the past year at BMC primary care practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone, for both groups, will occur 6, 12, and 18 months after enrollment.

Read the detailed description

Cigarette smoking is a highly significant health threat, responsible for > 480,000 deaths in the US each year, many due to cancer, and is the largest cause of preventable morbidity and mortality in the US. Primary care settings provide an opportunity to reach large proportions of low-income smokers, as 61% of such smokers are engaged in medical care. The proposed project addresses this under-utilization of available smoking cessation services which is occurring despite considerable interest among low-income patients about quitting/receiving help with quitting. This intervention has the potential to increase the reach of existing services and in turn, to improve the public's health.

Patient financial incentives, while not yet used as standard of care for health promotion, are in the research stage for various types of conditions. Financial incentives are effective in promoting smoking cessation; but have not been extensively studied among low SES smokers. Financial incentives are a behavioral economic intervention that is effective in promoting smoking cessation, increasing cessation rates 3-fold compared to no incentives. The investigators believe financial incentives merit further study, particularly in low SES populations. Incentives for completing smoking cessation programs/achieving abstinence may be particularly effective among low SES smokers because they: 1) can alleviate some of the financial strain that prevents low SES smokers from quitting (studies have shown that the stress from financial problems prevents patients from quitting, even though quitting smoking could save people large amounts of money); 2) promote short-term abstinence among smokers with mental illness and substance use, many of whom are low SES smokers; 3) provide a substitute reinforcer for smoking (e.g., in lieu of hobbies, physical activity, work satisfaction) often absent in environments of low SES smokers and 4) provide extrinsic motivation for patients to quit smoking, and may be particularly effective among low SES smokers, many of whom in our recent pilot study were found to have low levels of intrinsic motivation. Our strategy is to combine financial incentives with patient navigation, as the latter may "supercharge" the former, for the two interventions may work in complementary ways. The investigators posit that incentives will augment people's willingness to connect with a navigator, and the navigator will put people in touch with resources/environments in which the incentives can work.

Patient navigation holds promise as an intervention to reduce cancer disparities, but alone may be insufficient to promote smoking cessation. Patient navigators are often lay persons from the community who guide patients through the health care system so that they receive appropriate services. While patient navigation has been shown to be an effective intervention to reduce health care disparities, prior patient navigation studies have been limited to the realms of cancer screening and diagnosis. Preliminary findings from our pilot RCT of patient navigation to promote smoking cessation among low SES and minority primary care patients at Boston Medical Center suggest that a more potent intervention may be needed. While a patient navigator was able to link 37% of patients to treatment, she was unable to contact or meaningfully connect with 53% of patients. Thus, financial incentives may be used to increase participant motivation to connect with patient navigators.

Combining financial incentives with patient navigation may be an effective approach to promote cessation among low SES and minority smokers. Multicomponent interventions have shown the most promise in changing health behaviors in general, and in reducing health disparities. Barriers to behavior change among socially disadvantaged persons may be so large that no single intervention can be effective. The investigators have therefore chosen to implement two intervention components, financial incentives and patient navigation, which have shown some promise in smoking cessation, and are currently being applied in the health disparities field to other health conditions.

Our objectives and hypotheses are:

Specific Aim I: To determine whether patient navigation and financial incentives increase the rates at which primary care patients engage in smoking cessation treatment.

H1: Compared to control patients, those assigned to the intervention will be more likely to engage in smoking cessation treatment at six months post-enrollment.

Specific Aim II: To determine whether patient navigation and financial incentives increase the rates at which primary care patients quit smoking (our primary outcome), defined as biochemically confirmed cessation at twelve months using salivary cotinine levels.

H1: Compared to ETC patients, those assigned to the patient navigation/financial incentives intervention will be more likely to be abstinent at 12 months post-enrollment.

Being tested
Intervention, Enhanced Traditional Care control
Keywords
smoking cessation, patient navigation, financial incentives, health disparities
Medical subject headings
Smoking Cessation

What participants receive

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

  • InterventionBehavioural

    Intervention patients will be introduced to the patient navigator either in person or by telephone. The intervention patients will receive navigation from one of two trained navigators, based centrally in the Section of General Internal Medicine. The purpose of the patient navigation interactions is to 1) connect patients to existing yet underutilized smoking cessation resources and 2) increase patient commitment to follow through with existing treatment services.

    Financial incentives: $250 for biochemically confirmed abstinence within six months after study enrollment, and $500 for biochemically confirmed abstinence for an additional six months after the initial cessation.

  • Enhanced Traditional Care controlOther

    List of smoking cessation resources and educational brochure.

Study groups in NCT02351609
Study groupRoleWhat they receive
InterventionExperimentalPatients in this arm will receive a low literacy smoking cessation educational brochure and a list of resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 6-month period. Patients will receive financial incentives for biochemically confirmed smoking cessation.
Receives: Behavioral: Intervention
Enhanced Traditional Care controlActive comparatorPatients receive information about smoking cessation resources and an educational brochure developed by the Massachusetts Department of Public Health.
Receives: Other: Enhanced Traditional Care control

What is being measured

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

  1. Smoking abstinence at 12 months post-enrollment

    Measured: 12 months

Timeline

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

  1. First posted30 Jan 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion3 Mar 2017
  4. Study completion1 Oct 2017

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351609
Sponsor's protocol ID
H-3296
Other IDs
125785-RSG-14-034-01CPPB
Status last verified
Oct 2017
First submitted
27 Jan 2015
Last updated
5 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abidoye O, Ferguson MK, Salgia R. Lung carcinoma in African Americans. Nat Clin Pract Oncol. 2007 Feb;4(2):118-29. doi: 10.1038/ncponc0718.

    PubMed 17259932
  • Yancy CW. Executive summary of the African-American Initiative. MedGenMed. 2007 Feb 8;9(1):28.

    PubMed 17435635
  • Kurian AK, Cardarelli KM. Racial and ethnic differences in cardiovascular disease risk factors: a systematic review. Ethn Dis. 2007 Winter;17(1):143-52.

    PubMed 17274224
  • Unger B, Kemp JS, Wilkins D, Psara R, Ledbetter T, Graham M, Case M, Thach BT. Racial disparity and modifiable risk factors among infants dying suddenly and unexpectedly. Pediatrics. 2003 Feb;111(2):E127-31. doi: 10.1542/peds.111.2.e127.

    PubMed 12563085
  • Cokkinides VE, Halpern MT, Barbeau EM, Ward E, Thun MJ. Racial and ethnic disparities in smoking-cessation interventions: analysis of the 2005 National Health Interview Survey. Am J Prev Med. 2008 May;34(5):404-12. doi: 10.1016/j.amepre.2008.02.003.

    PubMed 18407007
  • Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.

    PubMed 19213683
  • Higgins ST, Alessi SM, Dantona RL. Voucher-based incentives. A substance abuse treatment innovation. Addict Behav. 2002 Nov-Dec;27(6):887-910. doi: 10.1016/s0306-4603(02)00297-6.

    PubMed 12369474
  • Van Etten ML, Higgins ST, Budney AJ, Badger GJ. Comparison of the frequency and enjoyability of pleasant events in cocaine abusers vs. non-abusers using a standardized behavioral inventory. Addiction. 1998 Nov;93(11):1669-80. doi: 10.1046/j.1360-0443.1998.931116695.x.

    PubMed 9926530
  • Higgins ST, Bickel WK, Hughes JR. Influence of an alternative reinforcer on human cocaine self-administration. Life Sci. 1994;55(3):179-87. doi: 10.1016/0024-3205(94)00878-7.

    PubMed 8007760
  • Audrain-McGovern J, Rodriguez D, Epstein LH, Rodgers K, Cuevas J, Wileyto EP. Young adult smoking: what factors differentiate ex-smokers, smoking cessation treatment seekers and nontreatment seekers? Addict Behav. 2009 Dec;34(12):1036-41. doi: 10.1016/j.addbeh.2009.06.012. Epub 2009 Jul 5.

    PubMed 19619948
  • Chin MH, Walters AE, Cook SC, Huang ES. Interventions to reduce racial and ethnic disparities in health care. Med Care Res Rev. 2007 Oct;64(5 Suppl):7S-28S. doi: 10.1177/1077558707305413.

    PubMed 17881624
  • Donatelle RJ, Prows SL, Champeau D, Hudson D. Randomised controlled trial using social support and financial incentives for high risk pregnant smokers: significant other supporter (SOS) program. Tob Control. 2000;9 Suppl 3(Suppl 3):III67-9. doi: 10.1136/tc.9.suppl_3.iii67. No abstract available.

    PubMed 10982912
  • Shoptaw S, Jarvik ME, Ling W, Rawson RA. Contingency management for tobacco smoking in methadone-maintained opiate addicts. Addict Behav. 1996 May-Jun;21(3):409-12. doi: 10.1016/0306-4603(95)00066-6.

    PubMed 8883490
  • Dohan D, Schrag D. Using navigators to improve care of underserved patients: current practices and approaches. Cancer. 2005 Aug 15;104(4):848-55. doi: 10.1002/cncr.21214.

    PubMed 16010658
  • Lasser KE, Murillo J, Medlin E, Lisboa S, Valley-Shah L, Fletcher RH, Emmons KM, Ayanian JZ. A multilevel intervention to promote colorectal cancer screening among community health center patients: results of a pilot study. BMC Fam Pract. 2009 May 29;10:37. doi: 10.1186/1471-2296-10-37.

    PubMed 19480698

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Smoking Cessation, run by Boston Medical Center at 1 site 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 1 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Smoking abstinence at 12 months post-enrollment (time frame: 12 months). 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 NCT02351609, which also lists 47 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 5 Oct 2017.

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