Clinical trial NCT02730260: Worksite Phone Counseling for Smoking Cessation
Official title: Worksite Phone Counseling for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Directive coaching
Nondirective coaching
smoking cessation quitline
social support
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence for 7 Days at Last Contact
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Walton Sumner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sumner W 2nd, Walker MS, Highstein GR, Fischer I, Yan Y, McQueen A, Fisher EB. A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline. BMC Public Health. 2016 Jul 11;16:550. doi: 10.1186/s12889-016-3202-y.