Smoking Cessation
Conditions
Keywords
Directive coaching, Nondirective coaching, smoking cessation quitline, social support
Brief summary
Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.
Detailed description
BACKGROUND Given the association of smoking with low socioeconomic status, the potential of telephone counseling for smoking cessation to reach diverse audiences needs evaluation. In addition, different approaches to counseling have not been systematically examined, and may differentially affect reach, retention, and success. PURPOSE To describe employee participation and outcomes in a trial of two counseling styles for telephone-based smoking cessation support. APPROACH Employees and spouses of two large organizations are invited to participate in a trial of a telephone quitline. Participants are randomized to one of two coaching styles. A protocol-driven (Directive) coaching approach follows a script for each of seven calls over 9 weeks. A participant-centered (Nondirective) coaching approach allowed smokers to select topics of interest, with prompting by the coach as needed. A computer assisted telephone interview program and database provide topics in correct sequence for directive coaching, allow coaches to indicate topics during nondirective coaching, and track time spent on topics in both conditions. PREDICTOR VARIABLES Demographics, smoking history and conventional self-reported measures of nicotine dependence, smoking urges, preference for patient-centric care, and depression are collected at baseline. OUTCOMES The primary outcome measure is self-reported abstinence from smoking for 7 days at the time of last follow up, 6 or 12 months after baseline assessment. ANALYSES Interactions of Race and Income with coaching approach are analyzed. Based on results with asthma patients, a positive interaction of low income with nondirective coaching is tested.
Interventions
BEHAVIORALNondirective smoking cessation coaching
Quitline coach allows participant to set agenda for each call.
BEHAVIORALDirective smoking cessation coaching
Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change * English speaking
Exclusion criteria
* Smoker in precontemplation stage of change
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence for 7 Days at Last Contact | 6-12 months | By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment. |
Countries
United States
Participant flow
Pre-assignment details
978 persons inquired about the program. 847 took steps to qualify for an employer health insurance discount Of these, 294 declined to enroll, e.g. for being in the precontemplative stage of change. 553 persons participated in coaching. Of these, 35 worked with coaches in training. 518 participants enrolled in the randomized trial.
Participants by arm
| Arm | Count |
|---|---|
| Directive Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.
Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. | 258 |
| Nondirective Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.
Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call. | 260 |
| Total | 518 |
Baseline characteristics
| Characteristic | Directive | Nondirective | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 254 Participants | 506 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.3 | 46.0 years STANDARD_DEVIATION 10.6 | 46.2 years STANDARD_DEVIATION 10.9 |
| Education | 6 units on a scale | 6 units on a scale | 6 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 250 Participants | 252 Participants | 502 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Fagerström Test for Nicotine Dependence (FTND) | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Gender Female | 172 Participants | 172 Participants | 344 Participants |
| Gender Male | 86 Participants | 88 Participants | 174 Participants |
| Income | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 51 Participants | 101 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) White | 199 Participants | 199 Participants | 398 Participants |
| Region of Enrollment United States | 258 participants | 260 participants | 518 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 258 | 0 / 260 |
| serious Total, serious adverse events | 0 / 258 | 0 / 260 |
Outcome results
Primary
Smoking Abstinence for 7 Days at Last Contact
By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.
Time frame: 6-12 months
Population: These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Directive | Smoking Abstinence for 7 Days at Last Contact | 68 participants |
| Nondirective | Smoking Abstinence for 7 Days at Last Contact | 77 participants |
Comparison: Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.p-value: 0.41Chi-squared
Comparison: Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.p-value: <0.03Regression, Logistic
Comparison: Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.p-value: <0.03Regression, Logistic