Integrating Smoking Cessation Into Routine Primary Care Practice
5 de octubre de 2010 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
835
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
smoking abstinence
Periodo de tiempo: 16-weeks
|
Self-report and biochemically validated point prevelence smoking abstinence
|
16-weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
cost-effectiveness
Periodo de tiempo: 16-weeks
|
16-weeks
|
|
|
Rate of provider delivery of evidence-based smoking treatments
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul McDonald, PhD, University of Waterloo
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2009
Finalización primaria (Actual)
1 de abril de 2010
Finalización del estudio (Actual)
1 de septiembre de 2010
Fechas de registro del estudio
Enviado por primera vez
17 de noviembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
26 de noviembre de 2008
Publicado por primera vez (Estimar)
27 de noviembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de octubre de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
5 de octubre de 2010
Última verificación
1 de octubre de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 15053
- CTCRI 019826 (Otro número de subvención/financiamiento: Canadian Tobacco Control Research Initiative)
- CTCRI 19813 (Otro número de subvención/financiamiento: Canadian Tobacco Control Research Initiative)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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