- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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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Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Validated 7-day point prevalence tobacco abstinence
Tidsramme: 6 months after discharge
|
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
|
6 months after discharge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Use of tobacco treatment after hospital discharge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 month follow-up
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6 month follow-up
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|
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Self-reported 7-day point prevalence tobacco abstinence
Tidsramme: 3 months after hospital dicharge
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3 months after hospital dicharge
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|
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Self-reported 7-day point prevalence tobacco abstinence
Tidsramme: 1 month after hospital discharge
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1 month after hospital discharge
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|
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Prolonged tobacco abstinence
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Enzymhæmmere
- Psykotropiske stoffer
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhæmmere
- Ganglionstimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, anden generation
- Cytokrom P-450 CYP2D6-hæmmere
- Dopaminoptagelseshæmmere
- Nikotin
- Bupropion
- Vareniclin
Andre undersøgelses-id-numre
- 1RC1HL099668 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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