Disease Management for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.

Detailed Description
-----------------
The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician. The primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care.

Official Title
-----------------
Disease Management for Smokers in Rural Primary Care

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: High intensity disease management
* Behavioral: Low intensity disease management
* Behavioral: Comparison group
* Drug: Bupropion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days Speak English Their regular physician is a participating physician Working home telephone or cellular phone Exclusion Criteria: Women who are pregnant or planning to become pregnant in the next two years Plan on moving within two years Display signs of dementia or other mental disorders Live with a smoker already enrolled

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity disease management<br>High intensity disease management, free nicotine replacement therapy or bupropion | Behavioral: High intensity disease management<br>* Health education mailings, 6 motivation interviews/counseling<br>Drug: Bupropion<br>* Buproprion or Nicotine Replacement Therapy<br>* Other names: Nicotine Replacement Therapy;|
| Experimental: Low intensity disease management<br>Low intensity disease management, free nicotine replacement therapy or bupropion | Behavioral: Low intensity disease management<br>* Health education mailings, one motivation interview/counseling<br>Drug: Bupropion<br>* Buproprion or Nicotine Replacement Therapy<br>* Other names: Nicotine Replacement Therapy;|
| Other: Comparison group<br>Comparison group, free nicotine replacement therapy or bupropion | Behavioral: Comparison group<br>* Health education mailings<br>Drug: Bupropion<br>* Buproprion or Nicotine Replacement Therapy<br>* Other names: Nicotine Replacement Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence Abstinence From Cigarettes | Self-reported 7-day point prevalence abstinence from cigarettes | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Quit Attempts | Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period. | 6, 12, 18, 24 months | 
| Progress in Stage of Change | Progress in Stages of Change at 6, 12, 18, and 24 months | 6, 12, 18, 24 months |