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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| Northeastern Illinois University | OTHER |
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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.
An estimated 26 million smokers still receive no treatment for their smoking during their primary care visits. Given the persistent clinical system, provider, and patient barriers to addressing smoking in primary care, especially for poor populations, an electronic health record (EHR)-automated population health management approach that directly links the healthcare system with public health services to engage all smokers may increase access to effective treatment. Increased access is especially significant for low-income smokers who are underserved and who carry a disproportionate burden of tobacco-related disease. While 90% of smokers are not ready to quit, many are interested in cutting down, and smoking reduction increases the likelihood of future quit attempts and smoking cessation. Based on self-determination theory, population outreach targeted to low-income smokers that offers them the choice to either quit or cut down as a first step towards cessation may increase their engagement in and utilization of smoking cessation treatment and likelihood of achieving abstinence. This 2-group randomized controlled trial will evaluate the effectiveness of a population health management intervention for smoking cessation in low-income smokers. Participants will be 530 diverse, low-income smokers of a large Federally Qualified Health Center (FQHC) in Chicago identified using its EHR system. Automated via the EHR system, participants will be mailed a letter on behalf of their providers that encourages smoking cessation or smoking reduction as a first step to quitting (Choose to Change; N=265). The letter will be paired with 5 text messages 2-3 days apart that are designed to reinforce the central messaging of the letter ("Choose to change and make your own goal"). All components of the Choose to Change intervention will be offered in English and Spanish. Two weeks after letter mailing and automated electronic referral, participants will receive a call from the Illinois Tobacco Quitline and offered free behavioral counseling and free nicotine replacement therapy (NRT; patch, gum, or lozenge) for smoking cessation or reduction. Treatment will continue as either accepted or initiated by participants for 28 weeks. Treatment outcomes will be transmitted directly from the Quitline server to the EHR system. Choose to Change will be compared with Enhanced Usual Care (N=265), in which an electronic referral for proactive Quitline treatment is made during a clinic visit. The primary study outcomes will be treatment engagement (initial counseling call completed) at 6 weeks, utilization (one or more additional counseling calls completed) at 14 weeks, and smoking cessation (bioverified 7-day point-prevalence abstinence) at 28 weeks. An exploratory aim is to examine moderators of intervention effects. An EHR-automated population health management intervention targeted to low-income smokers could reduce critical disparities in treatment access, utilization, and cessation. If determined to be effective, the Choose to Change intervention could be readily disseminated to 11 other FQHCs in Chicago, comprising 85 clinical sites that care for almost 500,000 low-income patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population health management | Experimental | Population health management for smoking cessation in low-income smokers: the Choose to Change intervention |
|
| Enhanced usual care | Active Comparator | Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation at Week 14 (18 Weeks After Enrollment) | Self-reported seven-day point-prevalence abstinence at week 14. 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 14 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brian Hitsman, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24073176 | Background | 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. | |
| 17132521 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Population Health Management | Population health management for smoking cessation in low-income smokers: the Choose to Change intervention Choose to Change: 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). |
| FG001 | Enhanced Usual Care | Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment Enhanced usual care: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 6 (10 Weeks After Enrollment) |
| |||||||||||||
| Week 14 (18 Weeks After Enrollment) |
| |||||||||||||
| Week 28 (32 Weeks After Enrollment) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Population Health Management | Population health management for smoking cessation in low-income smokers: the Choose to Change intervention Choose to Change: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Week 6 |
|
No adverse events were collected or assessed for this study.
Not applicable. No adverse events were collected or assessed for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Population Health Management | Population health management for smoking cessation in low-income smokers: the Choose to Change intervention Choose to Change: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Hitsman, PhD | Northwestern University | 312-503-2074 | b-hitsman@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2018 | Sep 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 |
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|
| 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. |
|
| 16448302 | 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. |
| 22695462 | 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. |
| 21074681 | 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. |
| 12660210 | 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. |
| 9224190 | 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. |
| 23821093 | 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. |
| 22092035 | 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. |
| 19373517 | 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. |
| 22851111 | 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. |
| 36205472 | Derived | 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. |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Enhanced Usual Care | Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment Enhanced usual care: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Enhanced Usual Care |
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment Enhanced usual care: 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. |
|
|
| Primary | Quitline Treatment Utilization | The number of participants who completed one or more additional quitline counseling calls. | Posted | Count of Participants | Participants | Week 14 |
|
|
|
| Primary | 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. | Due to project timeline constraints, only the first 96 participants were followed for 32 weeks. | Posted | Count of Participants | Participants | Week 28 |
|
|
|
| Secondary | Smoking Cessation at Week 14 (18 Weeks After Enrollment) | Self-reported seven-day point-prevalence abstinence at week 14. 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. | Posted | Count of Participants | Participants | Week 14 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Enhanced Usual Care | Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment Enhanced usual care: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |