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Integrating Smoking Cessation Into Routine Primary Care Practice

5. oktober 2010 opdateret af: University of Waterloo

Comparative Evaluation of the Efficacy and Cost-effectiveness of Two Interventions for Integrating Smoking Cessation Into Routine Primary Care Practice: A Cluster-randomized Trial

The aim of this study is to determine if providing smokers identified in family doctors offices with follow-up counselling enhances their success with quitting and the number of health professionals helping patients with quitting. Six to eight family medicine clinics will be involved in the study. We will compare the frequency of addressing smoking with patients and the proportion of smokers who are successful with quitting 16-weeks following the clinic appointment between practices. It is hypothesized that the addition of follow-up counseling to a multi-component smoking cessation intervention will improve smoking outcomes.

Studieoversigt

Detaljeret beskrivelse

A family doctor's advice to quit has been shown to increase a smoker's motivation to quit. Despite the evidence supporting the importance of smoking cessation, there is a well-documented practice gap in the rates at which smoking cessation is being addressed by practitioners. The primary objectives of this research study are to determine whether adjunct telephone-based smoking cessation follow-up counselling when delivered as part of a multi-component intervention:

  1. Increases the rate at which evidence-based smoking cessation interventions are delivered to smokers identified in family doctors offices, compared to providing only practice supports.
  2. Increases smoking abstinence as measured three months after the estimated target quit date (i.e.16 weeks) compared to providing only practice supports.
  3. Is more cost-effective (cost/quit) than providing only practice supports to family doctors offices.

A two-arm before-after matched-pair cluster randomized trial, will test the effectiveness of two strategies for integrating smoking cessation treatments into primary care practice routines and enhancing cessation. Six to eight family doctors offices will be randomized to either a practice support (PS) group, or a follow-up counseling (FC) group. From each of the intervention practices a cross-sectional sample of 50 eligible smokers will be recruited pre- and post-intervention to assess 5A's delivery and smoking abstinence.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

835

Fase

  • Ikke anvendelig

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:

  • Practices will be eligible for participation in the present study if they meet the following criteria:

    1. Practice is a family health team (FHT), family health group (FHG); or family health network (FHN);
    2. All physicians within the practice are willing to participate in the study;
    3. Practice will see an average of 50 patients per day and 10% of patients are smokers;
    4. Practice is willing to provide consent to contact patients in waiting rooms and survey patients during office hours and by telephone.
  • Patients will be eligible to participate in the study if they meet the following criteria:

    1. Patient is seen in clinic for annual exam or non-urgent visit;
    2. Patient is a current smoker (>1 cigarette per day on most days of the week);
    3. Patient is 18 years of age or older;
    4. Patient is able to read and understand English or French;
    5. Patient has a home or mobile telephone which can be used to receive follow-up telephone counselling calls

Exclusion Criteria:

  • Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Follow-up Counseling Arm
smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers
The CF group will receive the same smoking cessation training and practice support tools delivered to the PS group. In addition, patients in the FC group who are smokers and are willing to set a quit date within the next 30 days and who have set a quit date will be enrolled in an interactive voice response (IVR)-mediated telephone follow-up and counselling system. The IVR system will automatically contact patients via telephone 7 days before their TQD, and 5, 14, 30, and 60 days after their TQD to check the patients' smoking status, potential concerns, and their risk of relapse.
Aktiv komparator: Practice Support Arm
smoking cessation training for providers,practice tools for providers, patient quit plan for smokers.
Intervention practices will be provided with training in smoking cessation, and will be supported with integrating a waiting room screener for smoking and smoking consult form and patient quit plan into their practice routines.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
smoking abstinence
Tidsramme: 16-weeks
Self-report and biochemically validated point prevelence smoking abstinence
16-weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cost-effectiveness
Tidsramme: 16-weeks
16-weeks
Rate of provider delivery of evidence-based smoking treatments
Tidsramme: exit survey on day of clinic visits
Rates of providers, asking, advising, assessing, assisting, and arranging were assessed
exit survey on day of clinic visits

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Paul McDonald, PhD, University of Waterloo

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. januar 2009

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

17. november 2008

Først indsendt, der opfyldte QC-kriterier

26. november 2008

Først opslået (Skøn)

27. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. oktober 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2010

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15053
  • CTCRI 019826 (Andet bevillings-/finansieringsnummer: Canadian Tobacco Control Research Initiative)
  • CTCRI 19813 (Andet bevillings-/finansieringsnummer: Canadian Tobacco Control Research Initiative)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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