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Patient Navigation and Financial Incentives to Promote Smoking Cessation

4. října 2017 aktualizováno: Karen Lasser, Boston Medical Center
Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden, smoking rates must be reduced among populations where smoking is disproportionately concentrated: those with low socioeconomic status (SES). The investigators will apply two methods that are being used in the field of health disparities to the challenge of promoting smoking cessation among low SES smokers. These include: 1) Patient navigation; patient navigators are often lay persons, working as paid employees, who guide patients through the health care system and 2) Financial incentives; investigators propose to provide monetary incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for an additional 6 months of abstinence after the initial cessation. The investigators will recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced Traditional Care control condition (smoking cessation brochure/list of cessation resources). The RCT will take place among adult daily smokers seen in the past year at BMC primary care practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone, for both groups, will occur 6, 12, and 18 months after enrollment.

Přehled studie

Detailní popis

Cigarette smoking is a highly significant health threat, responsible for > 480,000 deaths in the US each year, many due to cancer, and is the largest cause of preventable morbidity and mortality in the US. Primary care settings provide an opportunity to reach large proportions of low-income smokers, as 61% of such smokers are engaged in medical care. The proposed project addresses this under-utilization of available smoking cessation services which is occurring despite considerable interest among low-income patients about quitting/receiving help with quitting. This intervention has the potential to increase the reach of existing services and in turn, to improve the public's health.

Patient financial incentives, while not yet used as standard of care for health promotion, are in the research stage for various types of conditions. Financial incentives are effective in promoting smoking cessation; but have not been extensively studied among low SES smokers. Financial incentives are a behavioral economic intervention that is effective in promoting smoking cessation, increasing cessation rates 3-fold compared to no incentives. The investigators believe financial incentives merit further study, particularly in low SES populations. Incentives for completing smoking cessation programs/achieving abstinence may be particularly effective among low SES smokers because they: 1) can alleviate some of the financial strain that prevents low SES smokers from quitting (studies have shown that the stress from financial problems prevents patients from quitting, even though quitting smoking could save people large amounts of money); 2) promote short-term abstinence among smokers with mental illness and substance use, many of whom are low SES smokers; 3) provide a substitute reinforcer for smoking (e.g., in lieu of hobbies, physical activity, work satisfaction) often absent in environments of low SES smokers and 4) provide extrinsic motivation for patients to quit smoking, and may be particularly effective among low SES smokers, many of whom in our recent pilot study were found to have low levels of intrinsic motivation. Our strategy is to combine financial incentives with patient navigation, as the latter may "supercharge" the former, for the two interventions may work in complementary ways. The investigators posit that incentives will augment people's willingness to connect with a navigator, and the navigator will put people in touch with resources/environments in which the incentives can work.

Patient navigation holds promise as an intervention to reduce cancer disparities, but alone may be insufficient to promote smoking cessation. Patient navigators are often lay persons from the community who guide patients through the health care system so that they receive appropriate services. While patient navigation has been shown to be an effective intervention to reduce health care disparities, prior patient navigation studies have been limited to the realms of cancer screening and diagnosis. Preliminary findings from our pilot RCT of patient navigation to promote smoking cessation among low SES and minority primary care patients at Boston Medical Center suggest that a more potent intervention may be needed. While a patient navigator was able to link 37% of patients to treatment, she was unable to contact or meaningfully connect with 53% of patients. Thus, financial incentives may be used to increase participant motivation to connect with patient navigators.

Combining financial incentives with patient navigation may be an effective approach to promote cessation among low SES and minority smokers. Multicomponent interventions have shown the most promise in changing health behaviors in general, and in reducing health disparities. Barriers to behavior change among socially disadvantaged persons may be so large that no single intervention can be effective. The investigators have therefore chosen to implement two intervention components, financial incentives and patient navigation, which have shown some promise in smoking cessation, and are currently being applied in the health disparities field to other health conditions.

Our objectives and hypotheses are:

Specific Aim I: To determine whether patient navigation and financial incentives increase the rates at which primary care patients engage in smoking cessation treatment.

H1: Compared to control patients, those assigned to the intervention will be more likely to engage in smoking cessation treatment at six months post-enrollment.

Specific Aim II: To determine whether patient navigation and financial incentives increase the rates at which primary care patients quit smoking (our primary outcome), defined as biochemically confirmed cessation at twelve months using salivary cotinine levels.

H1: Compared to ETC patients, those assigned to the patient navigation/financial incentives intervention will be more likely to be abstinent at 12 months post-enrollment.

Typ studie

Intervenční

Zápis (Aktuální)

352

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02118
        • Boston Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

(1) age ≥ 18; (2) smoked ≥10 cigarettes/day in the past week; (3) have a scheduled visit with a PCP at BMC on the day of enrollment or within the next six months; (4) telephone access (5) English speaking; (6) plan on quitting smoking within the next six months; (7) able and willing to participate in the study protocol and provide informed consent.

Exclusion Criteria:

(1) planning to move out of the area within the next six months; (2) cognitive impairments that preclude participation in study activities; (3) severe illness or distress; (4) inability to read/understand English; (5) actively using evidence-based smoking cessation treatment; (6) transient residence or lack of a telephone for follow-up assessments.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention
Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 6-month period. Patients will receive financial incentives for biochemically confirmed smoking cessation.

Intervention patients will be introduced to the patient navigator either in person or by telephone. The intervention patients will receive navigation from one of two trained navigators, based centrally in the Section of General Internal Medicine. The purpose of the patient navigation interactions is to 1) connect patients to existing yet underutilized smoking cessation resources and 2) increase patient commitment to follow through with existing treatment services.

Financial incentives: $250 for biochemically confirmed abstinence within six months after study enrollment, and $500 for biochemically confirmed abstinence for an additional six months after the initial cessation.

Aktivní komparátor: Enhanced Traditional Care control
Patients receive information about smoking cessation resources and an educational brochure developed by the Massachusetts Department of Public Health.
List of smoking cessation resources and educational brochure.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Smoking abstinence at 12 months post-enrollment
Časové okno: 12 months
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Karen Lasser, MD, Boston Medical Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2015

Primární dokončení (Aktuální)

3. března 2017

Dokončení studie (Aktuální)

1. října 2017

Termíny zápisu do studia

První předloženo

27. ledna 2015

První předloženo, které splnilo kritéria kontroly kvality

27. ledna 2015

První zveřejněno (Odhad)

30. ledna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. října 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. října 2017

Naposledy ověřeno

1. října 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • H-3296
  • 125785-RSG-14-034-01CPPB (Jiné číslo grantu/financování: American Cancer Society)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Intervention

3
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