NCT00799279

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 6, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

November 17, 2008

Last Update Submit

October 5, 2010

Conditions

Keywords

smokingcessationfamily medicineevidence-basedknowledge translationsmoking cessation, primary care

Outcome Measures

Primary Outcomes (1)

  • smoking abstinence

    Self-report and biochemically validated point prevelence smoking abstinence

    16-weeks

Secondary Outcomes (2)

  • cost-effectiveness

    16-weeks

  • Rate of provider delivery of evidence-based smoking treatments

    exit survey on day of clinic visits

Study Arms (2)

Follow-up Counseling Arm

EXPERIMENTAL

smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers

Behavioral: Smoking cessation training, support, and telephone follow-up

Practice Support Arm

ACTIVE COMPARATOR

smoking cessation training for providers,practice tools for providers, patient quit plan for smokers.

Behavioral: smoking cessation intervention

Interventions

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.

Follow-up Counseling Arm

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.

Practice Support Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Paul McDonald, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 27, 2008

Study Start

January 1, 2009

Primary Completion

April 1, 2010

Study Completion

September 1, 2010

Last Updated

October 6, 2010

Record last verified: 2010-10