Worksite Phone Counseling for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Directive smoking cessation coaching; Behavioral: Nondirective smoking cessation coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Directive; Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.	Behavioral: Directive smoking cessation coaching; Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
Experimental: Nondirective; Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.	Behavioral: Nondirective smoking cessation coaching; Quitline coach allows participant to set agenda for each call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-12 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Walton Sumner, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: social support; Directive coaching; Nondirective coaching; smoking cessation quitline
• Other Study ID Numbers: 04-1335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.