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Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2)

11. mai 2018 oppdatert av: Nancy A. Rigotti, Massachusetts General Hospital

Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a "teachable moment" for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions.

Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.

Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

1359

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
      • Salem, Massachusetts, Forente stater, 01970
        • North Shore Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Medical Center

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 (smoked at least 1 cigarette in the month before hospital admission and at least 1 cigarette per day when smoking at baseline rate in the month before hospital admission)
  • Counseled by hospital smoking counselor during hospital stay
  • Plans to stop smoking tobacco products after hospital discharge
  • Agrees to take home a supply of smoking cessation medication after discharge
  • Agrees to and able to accept telephone calls after hospital discharge

Exclusion Criteria:

  • No access to a telephone or unable to communicate by telephone
  • Severe psychiatric or neurologic disease precluding ability to provide informed consent and to be counseled
  • Pregnant, nursing, or planning to become pregnant in next 3 months
  • Unable to speak English
  • Medical instability precluding study participation

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
At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
Eksperimentell: Sustained Care
A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.
A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tobacco Abstinence - 6 Month Follow-up
Tidsramme: 6 months
Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Continuous Tobacco Abstinence
Tidsramme: 1 month, 3 months, 6 months
Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
1 month, 3 months, 6 months
Point Prevalence Tobacco Abstinence
Tidsramme: 1 month, 3 months, 6 months
7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
1 month, 3 months, 6 months
Duration of Tobacco Abstinence After Hospital Discharge
Tidsramme: 1 month, 3 months, 6 months
Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.
1 month, 3 months, 6 months
Use of Smoking Cessation Treatment After Hospital Discharge
Tidsramme: 1 month, 3 months, 6 months
Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).
1 month, 3 months, 6 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause Hospitalizations
Tidsramme: 12 months
Self-reported admission to a hospital in the 12 months after the index hospitalization.
12 months
All-cause Mortality
Tidsramme: 6 months
Death from any cause in the 6 months after hospital discharge
6 months

Samarbeidspartnere og etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

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. desember 2012

Primær fullføring (Faktiske)

1. oktober 2016

Studiet fullført (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først innsendt

22. oktober 2012

Først innsendt som oppfylte QC-kriteriene

23. oktober 2012

Først lagt ut (Anslag)

25. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2018

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1R01HL111821 (U.S. NIH-stipend/kontrakt)

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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