Reducing Tobacco Use Disparities Among Low-Income Adults

NCT03077737 | Completed Results

• 1 other identifier: 5U54CA203000
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Most smokers, especially those who are poor, do not receive smoking cessation treatment during their healthcare visits. This study is evaluating a novel population health management intervention for low-income smokers. Automated via an EHR system, which is bidirectionally linked with the Illinois Tobacco Quitline, the intervention comprises a mailed letter and text messaging designed to motivate low-income patients, most of whom are not ready to quit, to accept and use proactive quitline treatment. Increased access to free effective treatment via the integration of healthcare systems and state quitline services may be especially significant in its impact on low-income smokers who are underserved and who carry a much greater burden of tobacco-related disease.

Conditions

Cigarette Smoking; Nicotine Dependence

Keywords

Treatment access; Treatment utilization; Smoking cessation; Low income; Electronic health record system; Electronic referral

Outcome Measures

Primary Outcomes (3)

• Quitline Treatment Engagement

  The number of participants who accepted the quitline call and accepted treatment as defined by enrolling in treatment and completing the first counseling session. Participants who returned a quitline call, enrolled in treatment, and completed the first counseling session were also counted as having engaged in treatment.

  Week 6

• Quitline Treatment Utilization

  The number of participants who completed one or more additional quitline counseling calls.

  Week 14

• Smoking Cessation at Week 28 (32 Weeks After Enrollment)

  Self-reported seven-day point-prevalence abstinence at week 28. Number of participants who reporting smoking cessation at week 28. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.

  Week 28

Secondary Outcomes (1)

• Smoking Cessation at Week 14 (18 Weeks After Enrollment)

  Week 14

Study Arms (2)

Population health management

EXPERIMENTAL

Population health management for smoking cessation in low-income smokers: the Choose to Change intervention

Behavioral: Choose to Change

Enhanced usual care

ACTIVE COMPARATOR

Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment

Behavioral: Enhanced usual care

Interventions

Choose to Change BEHAVIORAL

Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).

Population health management

Enhanced usual care BEHAVIORAL

Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.

Enhanced usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women who are 18 years of age or older
• A patient who receives healthcare at one of the seven Near North Health Service Corporation community health centers in Chicago
• Daily or weekly cigarette smoker
• One or more healthcare visits within the past 12 months

You may not qualify if:

• Language preference other than English or Spanish for their healthcare
• No telephone number or address listed in the EHR system
• Lives with another patient who is already enrolled in the study

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator
• Northeastern Illinois University: collaborator

Study Sites (1)

Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• Piper ME, Baker TB, Mermelstein R, Collins LM, Fraser DL, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Oguss M, Fiore MC. Recruiting and engaging smokers in treatment in a primary care setting: developing a chronic care model implemented through a modified electronic health record. Transl Behav Med. 2013 Sep;3(3):253-63. doi: 10.1007/s13142-012-0178-8.

  PMID: 24073176 BACKGROUND

• Hughes JR, Carpenter MJ. Does smoking reduction increase future cessation and decrease disease risk? A qualitative review. Nicotine Tob Res. 2006 Dec;8(6):739-49. doi: 10.1080/14622200600789726.

  PMID: 17132521 BACKGROUND

• Williams GC, McGregor HA, Sharp D, Levesque C, Kouides RW, Ryan RM, Deci EL. Testing a self-determination theory intervention for motivating tobacco cessation: supporting autonomy and competence in a clinical trial. Health Psychol. 2006 Jan;25(1):91-101. doi: 10.1037/0278-6133.25.1.91.

  PMID: 16448302 BACKGROUND

• Jamal A, Dube SR, Malarcher AM, Shaw L, Engstrom MC; Centers for Disease Control and Prevention (CDC). Tobacco use screening and counseling during physician office visits among adults--National Ambulatory Medical Care Survey and National Health Interview Survey, United States, 2005-2009. MMWR Suppl. 2012 Jun 15;61(2):38-45.

  PMID: 22695462 BACKGROUND

• Boyle RG, Solberg LI, Fiore MC. Electronic medical records to increase the clinical treatment of tobacco dependence: a systematic review. Am J Prev Med. 2010 Dec;39(6 Suppl 1):S77-82. doi: 10.1016/j.amepre.2010.08.014.

  PMID: 21074681 BACKGROUND

• Yarnall KS, Pollak KI, Ostbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health. 2003 Apr;93(4):635-41. doi: 10.2105/ajph.93.4.635.

  PMID: 12660210 BACKGROUND

• Baker DW, Parker RM, Williams MV, Clark WS, Nurss J. The relationship of patient reading ability to self-reported health and use of health services. Am J Public Health. 1997 Jun;87(6):1027-30. doi: 10.2105/ajph.87.6.1027.

  PMID: 9224190 BACKGROUND

• Lindson-Hawley N, Aveyard P, Hughes JR. Gradual reduction vs abrupt cessation as a smoking cessation strategy in smokers who want to quit. JAMA. 2013 Jul 3;310(1):91-2. doi: 10.1001/jama.2013.6473.

  PMID: 23821093 BACKGROUND

• Hiscock R, Bauld L, Amos A, Fidler JA, Munafo M. Socioeconomic status and smoking: a review. Ann N Y Acad Sci. 2012 Feb;1248:107-23. doi: 10.1111/j.1749-6632.2011.06202.x. Epub 2011 Nov 17.

  PMID: 22092035 BACKGROUND

• Williams GC, Niemiec CP, Patrick H, Ryan RM, Deci EL. The importance of supporting autonomy and perceived competence in facilitating long-term tobacco abstinence. Ann Behav Med. 2009 Jun;37(3):315-24. doi: 10.1007/s12160-009-9090-y. Epub 2009 Apr 17.

  PMID: 19373517 BACKGROUND

• Landon BE, Grumbach K, Wallace PJ. Integrating public health and primary care systems: potential strategies from an IOM report. JAMA. 2012 Aug 1;308(5):461-2. doi: 10.1001/jama.2012.8227. No abstract available.

  PMID: 22851111 BACKGROUND

• Hitsman B, Matthews PA, Papandonatos GD, Cameron KA, Rittner SS, Mohanty N, Long T, Ackermann RT, Ramirez E, Carr J, Cordova E, Bridges C, Flowers-Carson C, Giachello AL, Hamilton A, Ciecierski CC, Simon MA. An EHR-automated and theory-based population health management intervention for smoking cessation in diverse low-income patients of safety-net health centers: a pilot randomized controlled trial. Transl Behav Med. 2022 Oct 7;12(9):892-899. doi: 10.1093/tbm/ibac026.

  PMID: 36205472 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Results Point of Contact

• Title: Dr. Brian Hitsman, PhD
• Organization: Northwestern University

b-hitsman@northwestern.edu

312-503-2074

Study Officials

• Brian Hitsman, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Preventive Medicine

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 13, 2017
• Study Start: April 21, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: January 21, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)