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Reducing Tobacco Use Disparities Among Low-Income Adults

13 januari 2022 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

190

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University Feingberg School of Medicine, Dept. of Preventive Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion criteria

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

Exclusion criteria

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Aktiv komparator: Enhanced usual care
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quitline Treatment Engagement
Tidsram: 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
Tidsram: Week 14
The number of participants who completed one or more additional quitline counseling calls.
Week 14
Smoking Cessation at Week 28 (32 Weeks After Enrollment)
Tidsram: 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.
Week 28

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Brian Hitsman, PhD, Northwestern University Feinberg School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 april 2017

Primärt slutförande (Faktisk)

31 augusti 2018

Avslutad studie (Faktisk)

31 augusti 2018

Studieregistreringsdatum

Först inskickad

1 mars 2017

Först inskickad som uppfyllde QC-kriterierna

7 mars 2017

Första postat (Faktisk)

13 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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