- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01177176
Smoking Interventions for Hospital Patients (Helping HAND)
Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial
Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related disease or death. A hospital admission provides an opportunity for a smoker to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for >1 month after discharge. Smoking cessation medications add benefit to counseling but are not often used. The challenge is to translate this efficacy research into routine clinical practice. The major barrier is to make the transition from inpatient to outpatient care. An evidence-based, cost-effective intervention model that can be adopted by U.S. hospitals is needed to realize the potential impact of hospital smoking interventions.
The Specific Aim of this project is to conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in hospitalized patients: (1) a hospital-only intervention that meets the current standard of the National Hospital Quality Measures("Standard Care"), and (2) an "Extended Care Management" model with 2 components that aims to encourage and facilitate the sustained use of smoking cessation treatment (counseling and medication use) after discharge in order to achieve long-term abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and feature 2 innovations: (1) to increase medication use, smokers willing to make a quit attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers interested in or most likely to benefit from continued counseling after discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care, is feasible and will increase (1) the use of smoking cessation treatment after discharge, (2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence 6 months after hospital discharge (primary outcome). The principal secondary outcome measure is self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months, prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The cost-effectiveness (cost per quit) of the interventions will be also be compared.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Cigarette smoker (daily smoker when smoking in usual way during the month before hospital admission)
- Counseled by hospital smoking counselor during hospital stay
- Plans to stop smoking tobacco products after hospital discharge
- Appropriate for use of smoking cessation medication after discharge
Exclusion Criteria:
- Expected hospital length of stay <24 hours
- Not expected to be discharged to home
- No access to a telephone
- Unable to communicate by telephone
- Severe psychiatric or neurologic disease precluding ability to be counseled
- Pregnant, nursing, or planning to become pregnant in next 3 months
- Active substance abuse other than tobacco
- Unable to speak English
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Standard Care
Standard tobacco counseling provided to hospital inpatients as part of routine, clinical-guideline compliant care in the study hospital.
No post-discharge treatment is offered in this arm.
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Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
|
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Experimentální: Extended Care Management
In addition to Standard Care, subjects in this arm receive Extended Care Management intervention to facilitate the continued use of smoking cessation treatment (counseling and medication use) after hospital discharge.
This consists of 3 months of telephone-based contact after discharge.
|
Telephone-based care management of tobacco cessation for 3 months after hospital discharge that features 2 innovations: (1) to increase medication use, smokers receive a free refillable 30-day sample of their choice of FDA-approved smoking cessation medication (nicotine replacement, bupropion, or varenicline) at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers seeking or most likely to benefit from continued counseling after hospital discharge.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Validated 7-day point prevalence tobacco abstinence
Časové okno: 6 months after discharge
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7-day point prevalence tobacco abstinence, validated by saliva cotinine <= 10 ng/ml or if using NRT, expired air CO <=9ppm, or confirmation by proxy
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6 months after discharge
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Use of tobacco treatment after hospital discharge
Časové okno: during 3 months and 6 months after hospital discharge
|
patient-reported receipt of either smoking cessation counseling (defined as contact in person or by telephone) or smoking cessation pharmacotherapy (use of nicotine replacement therapy, bupropion, or varenicline)in the 3 months after hospital discharge
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during 3 months and 6 months after hospital discharge
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Duration of tobacco abstinence after hospital discharge
Časové okno: Up to 6 months after hospital discharge
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Number of days that patient reports not smoking any tobacco product after hospital discharge
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Up to 6 months after hospital discharge
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Self-reported 7-day point prevalence tobacco abstinence
Časové okno: 6 month follow-up
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6 month follow-up
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Self-reported 7-day point prevalence tobacco abstinence
Časové okno: 3 months after hospital dicharge
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3 months after hospital dicharge
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Self-reported 7-day point prevalence tobacco abstinence
Časové okno: 1 month after hospital discharge
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1 month after hospital discharge
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Prolonged tobacco abstinence
Časové okno: at 1, 3, and 6 months after hospital discharge
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Self-reported 7-day point prevalence abstinence at each of 3 time points: 1 month, 3 months, and 6 months after hospital discharge
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at 1, 3, and 6 months after hospital discharge
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Continuous tobacco abstinence
Časové okno: Up to 6 months after hospital discharge
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Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge
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Up to 6 months after hospital discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
- Rigotti NA, Chang Y, Rosenfeld LC, Japuntich SJ, Park ER, Tindle HA, Levy DE, Reid ZZ, Streck J, Gomperts T, Kelley JHK, Singer DE. Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. J Gen Intern Med. 2017 Sep;32(9):1005-1013. doi: 10.1007/s11606-017-4085-z. Epub 2017 Jun 14.
- Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237.
- Japuntich SJ, Regan S, Viana J, Tymoszczuk J, Reyen M, Levy DE, Singer DE, Park ER, Chang Y, Rigotti NA. Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:124. doi: 10.1186/1745-6215-13-124.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Autonomní agenti
- Agenti periferního nervového systému
- Cholinergní činidla
- Inhibitory enzymů
- Psychotropní drogy
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Antidepresiva
- Dopaminové látky
- Inhibitory enzymu cytochromu P-450
- Ganglionové stimulanty
- Nikotinoví agonisté
- Cholinergní agonisté
- Antidepresiva, druhá generace
- Cytochrom P-450 Inhibitory CYP2D6
- Inhibitory vychytávání dopaminu
- Nikotin
- Bupropion
- Vareniklin
Další identifikační čísla studie
- 1RC1HL099668 (Grant/smlouva NIH USA)
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 .
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