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Efficacy and Cost of State Quitline Policies

28. april 2011 oppdatert av: Kaiser Permanente
State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. This study will answer key policy questions about how to most effectively support smokers who call the Oregon Quitline for assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2 randomized trial comparing the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies on the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan anc community cessation services. Costs will be assessed separately from the perspectives of the patients, health plans, the State (i.e., Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life saved will be calculated from each of these perspectives.

Studieoversikt

Detaljert beskrivelse

Anti-tobacco media campaigns in many states are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many other states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. Two investigators on this proposal (Hollis and McAfee) have a contract with the State of Oregon to provide the Oregon Quitline (OQL) services. The purpose of the proposed research effort is to collaborate further with State representatives to answer key policy questions about how to most effectively support smokers who call the OQL for assistance.

Our overall aim is to recruit 4,500 callers to the OQL to participate in a 3 x 2 randomized trial to compare the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies regarding the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan and community cessation services. Costs will be assessed separately from the perspective of the patients, health plan, the State (i.e., OQL), and society. The specific aims are described below:

  1. Compare the efficacy of three policies for supporting OQL callers:

    • Brief counseling with referral to caller's health plan cessation services (standard service);
    • Moderate counseling, referral to health plan, and one follow-up call to reinforce use of health plan services;
    • Moderate counseling, referral, and availability a multi-session telephonic intervention.
  2. Compare the efficacy of two policies regarding the provision of nicotine replacement:

    • No offer of nicotine replacement (current policy);
    • An offer of free nicotine replacement patches.
  3. Determine the costs and cost per quit of the additional policy interventions relative to usual care (i.e., standard service) from the following perspectives:

    • Societal perspective (total incremental costs per incremental quit);
    • State perspective (incremental cost per quit for OQL services);
    • Health plan perspective (based on differences in use of health plan cessation services);
    • Participant's perspective (based on differences in out-of-pocket expenses).
  4. Determine the incremental cost per year-of-life saved for the alternative policies relative to usual care.

Studietype

Intervensjonell

Registrering (Faktiske)

4614

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

    • Oregon
      • Portland, Oregon, Forente stater, 97227
        • Kaiser Permanente Center for Health Research
      • Portland, Oregon, Forente stater, 97232
        • Oregon Health Division/Center for Disease Prevention Epidemiology
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Free and Clear, Inc.

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

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 18+
  • Speak English or Spanish
  • Oregon resident
  • Smoke 5 or more cigarettes/day
  • Planning to quit within 30 days (or quit within in last 7 days)
  • Consent to random assignment and follow-up

Exclusion Criteria:

  • Health plan benefit includes free multi-session telephone counseling
  • Current or planned pregnancy or breast-feeding
  • Heart attack within the preceding month.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Dobbelt

Hva måler studien?

Primære resultatmål

Resultatmål
Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.

Sekundære resultatmål

Resultatmål
Participant self-reported (at 6 and 12 months) any tobacco use by type
amount used per day
stage of change
number of quit attempts
use of health plan and community cessation resources
intervention total cost, cost per participant, and cost per quit
incremental cost effectiveness ratios for each intervention compared to baseline
patterns of pharmacotherapy use
out-of-pocket expenses for cessation activities.

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Jack F. Hollis, PhD, Kaiser Permanente Foundation Hospitals/Center for Health Research
  • Hovedetterforsker: Timothy A McAfee, MD, Group Health Center for Health Promotion
  • Hovedetterforsker: Michael J Stark, PhD, Oregon Health Division/Center for Disease Prevention Epidemiology

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.

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. juni 2000

Primær fullføring (Faktiske)

1. januar 2005

Studiet fullført (Faktiske)

1. januar 2005

Datoer for studieregistrering

Først innsendt

18. august 2006

Først innsendt som oppfylte QC-kriteriene

18. august 2006

Først lagt ut (Anslag)

22. august 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. mai 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2011

Sist bekreftet

1. april 2011

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1 RO1-CA86242-1

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. .

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