Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALHigh intensity disease management
Health education mailings, 6 motivation interviews/counseling
BEHAVIORALLow intensity disease management
Health education mailings, one motivation interview/counseling
BEHAVIORALComparison group
Health education mailings
DRUGBupropion
Buproprion or Nicotine Replacement Therapy
Sponsors
National Cancer Institute (NCI)
GlaxoSmithKline
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Abstinence From Cigarettes | 24 months | Self-reported 7-day point prevalence abstinence from cigarettes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Quit Attempts | 6, 12, 18, 24 months | 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. |
| Progress in Stage of Change | 6, 12, 18, 24 months | Progress in Stages of Change at 6, 12, 18, and 24 months |
Countries
United States
Participant flow
Pre-assignment details
Smokers screened for eligibility (n=1827) Ineligible (n=714) Invited to participate (n=1113) Declined to participate (n=305) Unable to contact (n=58) Randomly assigned (n=750)
Participants by arm
| Arm | Count |
|---|---|
| High-intensity Disease Management Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions | 251 |
| Moderate-intensity Disease Management Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions | 249 |
| Pharmacotherapy Management (Comparison Group) Health education mailings, free nicotine replacement therapy or bupropion | 250 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 7 | 9 | 5 |
| Overall Study | Incarceration | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Moderate-intensity Disease Management | Pharmacotherapy Management (Comparison Group) | High-intensity Disease Management | Total |
|---|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 12.4 | 47.1 years STANDARD_DEVIATION 13.4 | 46.4 years STANDARD_DEVIATION 13.5 | 47.2 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 246 Participants | 249 Participants | 738 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 19 Participants | 19 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 225 Participants | 225 Participants | 221 Participants | 671 Participants |
| Region of Enrollment United States | 249 Participants | 250 Participants | 251 Participants | 750 Participants |
| Sex: Female, Male Female | 144 Participants | 144 Participants | 151 Participants | 439 Participants |
| Sex: Female, Male Male | 105 Participants | 106 Participants | 100 Participants | 311 Participants |
| Stage of change Contemplation | 153 Participants | 158 Participants | 146 Participants | 457 Participants |
| Stage of change Precontemplation | 20 Participants | 22 Participants | 23 Participants | 65 Participants |
| Stage of change Preparation | 76 Participants | 70 Participants | 82 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 251 | 11 / 249 | 6 / 250 |
| other Total, other adverse events | 63 / 251 | 46 / 249 | 19 / 250 |
| serious Total, serious adverse events | 15 / 251 | 2 / 249 | 2 / 250 |
Outcome results
Primary
7-day Point Prevalence Abstinence From Cigarettes
Self-reported 7-day point prevalence abstinence from cigarettes
Time frame: 24 months
Population: We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-intensity Disease Management | 7-day Point Prevalence Abstinence From Cigarettes | 68 Participants |
| Moderate-intensity Disease Management | 7-day Point Prevalence Abstinence From Cigarettes | 56 Participants |
| Pharmacotherapy Management (Comparison Group) | 7-day Point Prevalence Abstinence From Cigarettes | 56 Participants |
p-value: 0.5495% CI: [0.78, 1.61]Mixed Models Analysis
p-value: 0.1895% CI: [0.88, 2.02]Mixed Models Analysis
Secondary
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.
Time frame: 6, 12, 18, 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-intensity Disease Management | Number of Quit Attempts | Month 6 : Quit Attempted | 171 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 6 : Deceased/Incarcerated | 2 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 6 : No Quit Attempt | 78 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 12 : Quit Attempted | 95 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 12 : Deceased/Incarcerated | 3 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 12 : No Quit Attempt | 153 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 18 : Quit Attempted | 61 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 18 : Deceased/Incarcerated | 6 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 18 : No Quit Attempt | 184 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 24 : Quit Attempted | 59 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 24 : Deceased/Incarcerated | 7 quit attempts |
| High-intensity Disease Management | Number of Quit Attempts | Month 24 : No Quit Attempt | 185 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 24 : No Quit Attempt | 173 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 6 : Quit Attempted | 160 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 18 : Quit Attempted | 49 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 18 : No Quit Attempt | 191 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 6 : Deceased/Incarcerated | 4 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 12 : No Quit Attempt | 151 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 24 : Deceased/Incarcerated | 11 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 6 : No Quit Attempt | 85 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 18 : Deceased/Incarcerated | 9 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 12 : Deceased/Incarcerated | 5 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 12 : Quit Attempted | 93 quit attempts |
| Moderate-intensity Disease Management | Number of Quit Attempts | Month 24 : Quit Attempted | 65 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 12 : Quit Attempted | 114 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 12 : Deceased/Incarcerated | 3 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 24 : Quit Attempted | 55 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 12 : No Quit Attempt | 133 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 18 : Quit Attempted | 65 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 18 : Deceased/Incarcerated | 3 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 24 : Deceased/Incarcerated | 6 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 6 : Quit Attempted | 142 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 6 : Deceased/Incarcerated | 3 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 18 : No Quit Attempt | 182 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 6 : No Quit Attempt | 105 quit attempts |
| Pharmacotherapy Management (Comparison Group) | Number of Quit Attempts | Month 24 : No Quit Attempt | 189 quit attempts |
Secondary
Progress in Stage of Change
Progress in Stages of Change at 6, 12, 18, and 24 months
Time frame: 6, 12, 18, 24 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Preparation | 31 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Preparation | 50 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Pre-contemplation | 30 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Pre-contemplation | 24 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Quit (Action/Maintenance) | 59 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Deceased/Incarcerated | 6 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Quit (Action/Maintenance) | 43 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Unknown | 44 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Quit (Action/Maintenance) | 81 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Unknown | 60 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Deceased/Incarcerated | 3 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Preparation | 87 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Contemplation | 65 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Pre-contemplation | 23 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Unknown | 43 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Unknown | 30 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Contemplation | 55 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Contemplation | 59 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Contemplation | 70 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Preparation | 44 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 6 | Deceased/Incarcerated | 2 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 24 | Deceased/Incarcerated | 7 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 18 | Quit (Action/Maintenance) | 63 Participants |
| High-intensity Disease Management | Progress in Stage of Change | Month 12 | Pre-contemplation | 25 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Quit (Action/Maintenance) | 49 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Unknown | 49 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Deceased/Incarcerated | 9 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Deceased/Incarcerated | 4 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Pre-contemplation | 32 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Pre-contemplation | 25 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Contemplation | 61 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Preparation | 37 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Pre-contemplation | 34 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Quit (Action/Maintenance) | 65 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Unknown | 43 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 24 | Deceased/Incarcerated | 11 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Contemplation | 71 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Preparation | 84 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Preparation | 57 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Quit (Action/Maintenance) | 50 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Unknown | 32 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Quit (Action/Maintenance) | 37 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 12 | Deceased/Incarcerated | 5 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Pre-contemplation | 31 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Contemplation | 67 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Unknown | 25 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 18 | Preparation | 44 Participants |
| Moderate-intensity Disease Management | Progress in Stage of Change | Month 6 | Contemplation | 74 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Preparation | 74 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Pre-contemplation | 15 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Contemplation | 89 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Preparation | 98 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Quit (Action/Maintenance) | 28 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Unknown | 17 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 6 | Deceased/Incarcerated | 3 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Pre-contemplation | 24 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Contemplation | 83 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Preparation | 79 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Quit (Action/Maintenance) | 38 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Unknown | 23 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 12 | Deceased/Incarcerated | 3 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Pre-contemplation | 17 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Contemplation | 81 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Quit (Action/Maintenance) | 44 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Unknown | 31 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 18 | Deceased/Incarcerated | 3 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Pre-contemplation | 33 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Contemplation | 70 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Preparation | 46 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Quit (Action/Maintenance) | 66 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Unknown | 29 Participants |
| Pharmacotherapy Management (Comparison Group) | Progress in Stage of Change | Month 24 | Deceased/Incarcerated | 6 Participants |