Patient Navigation and Financial Incentives to Promote Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Patient Navigation and Financial Incentives to Promote Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351609
• Other study ID #: H-3296
• Secondary ID: 125785-RSG-14-03
• Status: Completed
• Phase: N/A
• First received: January 27, 2015
• Last updated: October 4, 2017
• Start date: May 1, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: October 1, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) 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.

Exclusion Criteria:

(1) 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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Intervention
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.

Other:
• Enhanced Traditional Care control
List of smoking cessation resources and educational brochure.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (45)

Abidoye O, Ferguson MK, Salgia R. Lung carcinoma in African Americans. Nat Clin Pract Oncol. 2007 Feb;4(2):118-29. Review. — View Citation

Abrams DB, Follick MJ, Biener L, Carey KB, Hitti J. Saliva cotinine as a measure of smoking status in field settings. Am J Public Health. 1987 Jul;77(7):846-8. — View Citation

An LC, Zhu SH, Nelson DB, Arikian NJ, Nugent S, Partin MR, Joseph AM. Benefits of telephone care over primary care for smoking cessation: a randomized trial. Arch Intern Med. 2006 Mar 13;166(5):536-42. — View Citation

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. — View Citation

Battaglia TA, Roloff K, Posner MA, Freund KM. Improving follow-up to abnormal breast cancer screening in an urban population. A patient navigation intervention. Cancer. 2007 Jan 15;109(2 Suppl):359-67. — View Citation

Caraballo RS, Giovino GA, Pechacek TF, Mowery PD, Richter PA, Strauss WJ, Sharp DJ, Eriksen MP, Pirkle JL, Maurer KR. Racial and ethnic differences in serum cotinine levels of cigarette smokers: Third National Health and Nutrition Examination Survey, 1988-1991. JAMA. 1998 Jul 8;280(2):135-9. — View Citation

Catalani C, Minkler M. Photovoice: a review of the literature in health and public health. Health Educ Behav. 2010 Jun;37(3):424-51. doi: 10.1177/1090198109342084. Epub 2009 Oct 1. Review. — View Citation

Centers for Disease Control and Prevention (CDC). State-specific secondhand smoke exposure and current cigarette smoking among adults - United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Nov 13;58(44):1232-5. — View Citation

Centers for Disease Control and Prevention (CDC). State-specific smoking-attributable mortality and years of potential life lost--United States, 2000-2004. MMWR Morb Mortal Wkly Rep. 2009 Jan 23;58(2):29-33. Erratum in: MMWR Morb Mortal Wkly Rep. 2009 Feb 6;58(4):91. — View Citation

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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View Citation

Condiotte MM, Lichtenstein E. Self-efficacy and relapse in smoking cessation programs. J Consult Clin Psychol. 1981 Oct;49(5):648-58. — View Citation

Crawford SL, Tennstedt SL, McKinlay JB. A comparison of anlaytic methods for non-random missingness of outcome data. J Clin Epidemiol. 1995 Feb;48(2):209-19. — View Citation

Curry SJ, Marlatt GA, Gordon J, Baer JS. A comparison of alternative theoretical approaches to smoking cessation and relapse. Health Psychol. 1988;7(6):545-56. — View Citation

Deci EL, Koestner R, Ryan RM. A meta-analytic review of experiments examining the effects of extrinsic rewards on intrinsic motivation. Psychol Bull. 1999 Nov;125(6):627-68; discussion 692-700. — View Citation

DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002 Sep;40(9):794-811. — View Citation

Dohan D, Schrag D. Using navigators to improve care of underserved patients: current practices and approaches. Cancer. 2005 Aug 15;104(4):848-55. — View Citation

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:III67-9. — View Citation

Emmons KM, Stoddard AM, Fletcher R, Gutheil C, Suarez EG, Lobb R, Weeks J, Bigby JA. Cancer prevention among working class, multiethnic adults: results of the healthy directions-health centers study. Am J Public Health. 2005 Jul;95(7):1200-5. Epub 2005 Jun 2. — View Citation

Fang CY, Ma GX, Tan Y, Chi N. A multifaceted intervention to increase cervical cancer screening among underserved Korean women. Cancer Epidemiol Biomarkers Prev. 2007 Jun;16(6):1298-302. — View Citation

Gilpin EA, Pierce JP, Farkas AJ. Duration of smoking abstinence and success in quitting. J Natl Cancer Inst. 1997 Apr 16;89(8):572-6. — View Citation

Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. — View Citation

Hergenrather KC, Rhodes SD, Cowan CA, Bardhoshi G, Pula S. Photovoice as community-based participatory research: a qualitative review. Am J Health Behav. 2009 Nov-Dec;33(6):686-98. Review. — View Citation

Higgins ST, Alessi SM, Dantona RL. Voucher-based incentives. A substance abuse treatment innovation. Addict Behav. 2002 Nov-Dec;27(6):887-910. Review. — View Citation

Higgins ST, Bickel WK, Hughes JR. Influence of an alternative reinforcer on human cocaine self-administration. Life Sci. 1994;55(3):179-87. — View Citation

Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, Vesey C, Saloojee Y. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987 Nov;77(11):1435-8. — View Citation

Kanjilal S, Gregg EW, Cheng YJ, Zhang P, Nelson DE, Mensah G, Beckles GL. Socioeconomic status and trends in disparities in 4 major risk factors for cardiovascular disease among US adults, 1971-2002. Arch Intern Med. 2006 Nov 27;166(21):2348-55. — View Citation

Kanner AD, Coyne JC, Schaefer C, Lazarus RS. Comparison of two modes of stress measurement: daily hassles and uplifts versus major life events. J Behav Med. 1981 Mar;4(1):1-39. — View Citation

Klesges RC, Brown K, Pascale RW, Murphy M, Williams E, Cigrang JA. Factors associated with participation, attrition, and outcome in a smoking cessation program at the workplace. Health Psychol. 1988;7(6):575-89. — View Citation

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

Lai DT, Cahill K, Qin Y, Tang JL. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006936. doi: 10.1002/14651858.CD006936.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;3:CD006936. — View Citation

Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. — View Citation

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. — View Citation

Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x. — View Citation

Romano PS, Bloom J, Syme SL. Smoking, social support, and hassles in an urban African-American community. Am J Public Health. 1991 Nov;81(11):1415-22. — View Citation

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. — View Citation

Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. Review. — View Citation

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. — View Citation

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. — View Citation

Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804. — View Citation

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. — View Citation

Wang C, Burris MA. Photovoice: concept, methodology, and use for participatory needs assessment. Health Educ Behav. 1997 Jun;24(3):369-87. — View Citation

Yancy CW. Executive summary of the African-American Initiative. MedGenMed. 2007 Feb 8;9(1):28. Review. — View Citation

Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutiérrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. — View Citation

* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence at 12 months post-enrollment		12 months

External Links

•   Agency for Healthcare Research and Quality
•   Quit For Life: A collaboration for a healthier workplace
•   Quitworks services for patients
•   Tobacco Data Statistics Fact Sheets
•   Urn Randomization