Integrating Smoking Cessation Into Routine Primary Care Practice
5 octobre 2010 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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:
- 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.
- Increases smoking abstinence as measured three months after the estimated target quit date (i.e.16 weeks) compared to providing only practice supports.
- 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.
Type d'étude
Interventionnel
Inscription (Réel)
835
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Practices will be eligible for participation in the present study if they meet the following criteria:
- Practice is a family health team (FHT), family health group (FHG); or family health network (FHN);
- All physicians within the practice are willing to participate in the study;
- Practice will see an average of 50 patients per day and 10% of patients are smokers;
- 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:
- Patient is seen in clinic for annual exam or non-urgent visit;
- Patient is a current smoker (>1 cigarette per day on most days of the week);
- Patient is 18 years of age or older;
- Patient is able to read and understand English or French;
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
smoking abstinence
Délai: 16-weeks
|
Self-report and biochemically validated point prevelence smoking abstinence
|
16-weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
cost-effectiveness
Délai: 16-weeks
|
16-weeks
|
|
|
Rate of provider delivery of evidence-based smoking treatments
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul McDonald, PhD, University of Waterloo
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2009
Achèvement primaire (Réel)
1 avril 2010
Achèvement de l'étude (Réel)
1 septembre 2010
Dates d'inscription aux études
Première soumission
17 novembre 2008
Première soumission répondant aux critères de contrôle qualité
26 novembre 2008
Première publication (Estimation)
27 novembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 octobre 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 octobre 2010
Dernière vérification
1 octobre 2010
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 15053
- CTCRI 019826 (Autre subvention/numéro de financement: Canadian Tobacco Control Research Initiative)
- CTCRI 19813 (Autre subvention/numéro de financement: Canadian Tobacco Control Research Initiative)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .