Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Smoking Interventions for Hospital Patients (Helping HAND)

16. september 2014 oppdatert av: Nancy A. Rigotti, Massachusetts General Hospital

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.

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

397

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
Eksperimentell: 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 navn:
  • vareniklin
  • bupropion
  • nikotinerstatningsterapi
  • interactive voice response
  • telephone counseling for smoking cessation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
during 3 months and 6 months after hospital discharge
Duration of tobacco abstinence after hospital discharge
Tidsramme: Up to 6 months after hospital discharge
Number of days that patient reports not smoking any tobacco product after hospital discharge
Up to 6 months after hospital discharge
Self-reported 7-day point prevalence tobacco abstinence
Tidsramme: 6 month follow-up
6 month follow-up
Self-reported 7-day point prevalence tobacco abstinence
Tidsramme: 3 months after hospital dicharge
3 months after hospital dicharge
Self-reported 7-day point prevalence tobacco abstinence
Tidsramme: 1 month after hospital discharge
1 month after hospital discharge
Prolonged tobacco abstinence
Tidsramme: at 1, 3, and 6 months after hospital discharge
Self-reported 7-day point prevalence abstinence at each of 3 time points: 1 month, 3 months, and 6 months after hospital discharge
at 1, 3, and 6 months after hospital discharge
Continuous tobacco abstinence
Tidsramme: Up to 6 months after hospital discharge
Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge
Up to 6 months after hospital discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2010

Primær fullføring (Faktiske)

1. november 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

3. august 2010

Først innsendt som oppfylte QC-kriteriene

5. august 2010

Først lagt ut (Anslag)

6. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere