## Protocol Section
### Identification Module
**NCT ID:** NCT00799279

**Brief Title:** Integrating Smoking Cessation Into Routine Primary Care Practice

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

#### Organization Study ID Info
**ID:** 15053
#### Organization
**Class:** OTHER
**Full Name:** University of Waterloo
#### Secondary ID Infos
**Domain:** Canadian Tobacco Control Research Initiative
**ID:** CTCRI 019826
**Type:** OTHER_GRANT
**Domain:** Canadian Tobacco Control Research Initiative
**ID:** CTCRI 19813
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-10-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-10-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-04

**Type:** ACTUAL

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2010-10

#### Study First Post Date
**Date:** 2008-11-27
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-17
**Study First Submit QC Date:** 2008-11-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Ottawa Heart Institute Research Corporation

**Class:** OTHER

**Name:** Canadian Tobacco Control Research Initiative

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Waterloo

#### Responsible Party

**Old Name Title:** Paul McDonald

**Old Organization:** University of Waterloo

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Smoking Cessation

**Keywords:**

- smoking

- cessation

- family medicine

- evidence-based

- knowledge translation

- smoking cessation, primary care

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 835

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** Follow-up Counseling Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: smoking cessation intervention

**Label:** Practice Support Arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Follow-up Counseling Arm

**Description:** 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.

**Name:** Smoking cessation training, support, and telephone follow-up

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Practice Support Arm

**Description:** 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.

**Name:** smoking cessation intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Self-report and biochemically validated point prevelence smoking abstinence

**Measure:** smoking abstinence

**Time Frame:** 16-weeks

#### Secondary Outcomes

**Measure:** cost-effectiveness

**Time Frame:** 16-weeks

**Description:** Rates of providers, asking, advising, assessing, assisting, and arranging were assessed

**Measure:** Rate of provider delivery of evidence-based smoking treatments

**Time Frame:** exit survey on day of clinic visits

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** University of Waterloo

**Name:** Paul McDonald, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
