Reducing Tobacco Use Disparities Among Low-Income Adults
2022年1月13日 更新者:Brian Hitsman、Northwestern University
Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
190
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion criteria
- 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
Exclusion criteria
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Population health management
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
|
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).
|
アクティブコンパレータ:Enhanced usual care
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Quitline Treatment Engagement
時間枠:Week 6
|
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
時間枠:Week 14
|
The number of participants who completed one or more additional quitline counseling calls.
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Week 14
|
Smoking Cessation at Week 28 (32 Weeks After Enrollment)
時間枠:Week 28
|
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.
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Week 28
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
時間枠:Week 14
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Brian Hitsman, PhD、Northwestern University Feinberg School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年4月21日
一次修了 (実際)
2018年8月31日
研究の完了 (実際)
2018年8月31日
試験登録日
最初に提出
2017年3月1日
QC基準を満たした最初の提出物
2017年3月7日
最初の投稿 (実際)
2017年3月13日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月21日
QC基準を満たした最後の更新が送信されました
2022年1月13日
最終確認日
2022年1月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 5U54CA203000 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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