Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

Study Overview
=================
Brief Summary
-----------------
A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates a large scale implementation strategy in a 2-armed community intervention trial. The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.

Detailed Description
-----------------
COPD is an increasing cause of death and morbidity and smoking is its primary cause. Professional smoking cessation treatment is very cost-effective and therefore recommended by national guidelines. A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The incremental cost-effectiveness ratio (ICER) was Euro 1012 showing that the protocol was cost-effective. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates an implementation strategy in a 2-armed community intervention trial. General practices (N=150, 2700 smoking patients with COPD) will be randomly allocated to the intervention or control condition. In the control condition the usual dissemination strategy of distributing guidelines and subsequent products through the professional channels (journals, postgraduate education) will take place. In the intervention condition a multifaceted implementation strategy wil be executed aimed at support of the general practice team (outreach education by a facilitator, support for detecting smoking patients with COPD, provision of patient education materials, help desk/website, telephone and e-mail reminders). The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures. Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months. Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients. A process analysis and evaluations by patients and professionals are an integral part of the study. A cost-effectiveness analysis taking a health care sector perspective will be performed and will show the expected costs per practice and an incremental cost-effectiveness ratio (ICER). The study will last 34 months, the intervention period will take 18 months per practice.

Official Title
-----------------
Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: Implementation of a combined smoking cessation strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Smoking Age 40 years or over Exclusion Criteria: Under control of lung specialist Not Dutch-speaking Serious physical of psychiatric comorbidity Under 40 years of age

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Implementation of a combined smoking cessation strategy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, smoking cessation, implementation, patient counseling, general practice