- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03077737
Reducing Tobacco Use Disparities Among Low-Income Adults
13 gennaio 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
190
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Population health management
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
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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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Quitline Treatment Engagement
Lasso di tempo: 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.
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Week 6
|
Quitline Treatment Utilization
Lasso di tempo: Week 14
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The number of participants who completed one or more additional quitline counseling calls.
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Week 14
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Smoking Cessation at Week 28 (32 Weeks After Enrollment)
Lasso di tempo: Week 28
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
Lasso di tempo: Week 14
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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.
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Week 14
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Brian Hitsman, PhD, Northwestern University Feinberg School of Medicine
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
21 aprile 2017
Completamento primario (Effettivo)
31 agosto 2018
Completamento dello studio (Effettivo)
31 agosto 2018
Date di iscrizione allo studio
Primo inviato
1 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
7 marzo 2017
Primo Inserito (Effettivo)
13 marzo 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 gennaio 2022
Ultimo verificato
1 gennaio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5U54CA203000 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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