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Quitlink : A Leveraging Solution to Tobacco Counseling

Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.

Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Among the most important evidence-based interventions in primary care is to offer counseling and pharmacotherapy to patients who use tobacco, but studies suggest that only a fraction of tobacco users receive this assistance. Office systems and other strategies can improve counseling rates but are not widely adoptable in primary care. We propose a novel solution that couples a simple office system, which is widely adoptable, with a form of third-party counseling (telephone quit lines) that most practices can access in the United States. Specifically, the three-part intervention includes (1) an in-office expanded "vital signs" intervention that prompts nurses (or medical assistants) to determine tobacco use status, offer brief advice, and assess readiness to quit as vital signs are obtained; (2) inviting preparation-stage tobacco users to obtain proactive telephone counseling (provided by the American Cancer Society) comprising three 30-minute sessions scheduled at the patient's convenience; and (3) feedback from the Society to the practice, including fax requisitions for prescription aids for quit attempts, progress reports on the results of counseling, and quarterly aggregate analyses of practice and clinician team referral outcomes. The Virginia Ambulatory Care Outcomes Research Network will partner with the American Cancer Society to test this strategy in a randomized controlled trial conducted at 16 primary care practices in Virginia. Because existing dissemination strategies serve mainly to increase identification of tobacco users and sometimes to increase brief advice, our primary outcome measure will be the proportion of tobacco users who receive substantive assistance: Assess, Assist, and Arrange of the 5As. Given the widening availability of state and national quit line programs, our model for referrals and bidirectional communication with primary care could markedly augment the effectiveness of both primary care and quit lines in promoting tobacco cessation and provide an attractive alternative for clinicians who lack the time and resources to provide effective counseling.

Undersøgelsestype

Interventionel

Tilmelding

3200

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0251
        • Virginia Ambulatory Care Outcomes Network (ACORN)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Current use of tobacco
  • Age 18 or older
  • Visit with a clinician that day
  • Patient at one of the 16 practices in the study

Exclusion Criteria:

  • Unable to participate in a self-administered exit survey

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Uddannelse/Rådgivning/Træning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients

Sekundære resultatmål

Resultatmål
The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
The proportion of patients in the preparation stage who consent to telephone counseling
How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
The proportion who completed three counseling sessions

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2005

Studieafslutning

1. juli 2006

Datoer for studieregistrering

Først indsendt

1. juni 2005

Først indsendt, der opfyldte QC-kriterier

1. juni 2005

Først opslået (Skøn)

2. juni 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2006

Sidst verificeret

1. oktober 2006

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1R21HS014854-01 (U.S.A. AHRQ 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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