Clinical Response to Biomarker Documentation of Child Secondhand Smoke Exposure

1. To do formative work with healthcare providers, clinic staff and parents to develop a protocol for a clinic system to routinely collect blood from children at risk of SHS exposure conduct laboratory testing for tobacco toxicants, document exposure in the electronic medical record (EMR) and incorporate the biomarker feedback into a parental smoking treatment plan.
2. To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on provider delivery of tobacco treatment services (primary outcome).
3. To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on parent smoking behavior (participation in smoking cessation treatment, smoking cessation and implementation of smoking restrictions).

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation; Secondhand Smoke Exposure; Biomarker Feedback; Provider Behavior
• Intervention / Treatment: Behavioral: Biomarker Feedback

Detailed Description

ABSTRACT Smoking and secondhand smoke (SHS) are responsible for nearly a half-million preventable deaths in the United States every year. Parent(s) who stop smoking incur health benefits, model non-smoking (and quitting) to children and stop exposure to SHS in the home, car and other locations. National initiatives from the American Academy of Pediatrics and the American Academy of Family Physicians urge healthcare providers to screen children for a history of SHS exposure and to recommend that parents stop smoking and restrict smoking at home, but compliance with these guidelines is poor and more than 25% of children in the U.S. continue to be involuntarily exposed to SHS in the home. Effective systems are needed to increase parental smoking cessation and implement home smoking restrictions. We propose preliminary studies to evaluate a novel intervention to accomplish these objectives. We hypothesize that a clinic system that routinely measures and reports levels of tobacco toxicants (tobacco-specific carcinogens, nicotine and cotinine) found in the urine of children exposed to SHS will 1) increase provider delivery of tobacco treatment, 2) increase parental participation in tobacco treatment, 3) increase parental smoking cessation and 4) reduce childhood exposure to secondhand smoke. We propose formative work among healthcare providers and parents to develop the intervention and to pilot test the effects of the intervention on providers and parents. We will conduct focus groups among staff to identify training needs, develop methods to integrate the intervention with office practice and assess barriers to implementation. We will also conduct focus groups among parents to assess willingness to provide urine specimens, optimal feedback format and reactions to biomarker data. Results from focus groups will be used to develop the experimental treatment protocol. We will test the intervention in a two-group randomized pilot study in the University of Minnesota Primary Care Clinic. We will recruit 80 children age 0-12 with a parent who smokes. We will provide brief behavioral counseling in healthy lifestyle options to all parents. One provider team will implement the experimental intervention in 40 parent-child pairs and the other team will serve as the control. Children who see providers in the experimental group will provide a urine sample to test for nitrosamines (a tobacco-specific carcinogen), nicotine and cotinine. We will communicate laboratory results to providers using the electronic medical record and incorporate these results in parental tobacco counseling designed to promote smoking cessation and home smoking restrictions. The primary outcome will be provider delivery of smoking cessation treatment. We will also measure effects on parental engagement in treatment, smoking cessation and institution of home smoking restrictions in both the experimental and control groups. The research team brings extensive experience with novel tobacco interventions, health services research and biomarker assessment to the project. Routine documentation of tobacco toxicants in children's urine has potential to dramatically alter clinical care for families at risk from smoking.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota Department of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12M or 24M well-visit
• Scheduled to a lead test
• Current smoker

Exclusion Criteria:

• Cannot speak English
• No phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biomarker feedback; Biomarkers of tobacco exposure (laboratory values) delivered to health care provider	Behavioral: Biomarker Feedback; Providing providers biomarker feedback on childhood secondhand smoke exposure
Placebo Comparator: Usual care (general counseling); Brochure about pesticides, lead, SHS	Behavioral: Biomarker Feedback; Providing providers biomarker feedback on childhood secondhand smoke exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Delivery of Tobacco Treatment Services	Whether or not biomarker feedback testing of secondhand smoke will prompt providers to deliver tobacco treatment services	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Smoking Behavior	Whether giving parents biomarker feedback on childhood exposure to secondhand smoke will lead to participation in smoking cessation treatment, smoking cessation and implementation of smoking restrictions.	12 weeks

Collaborators and Investigators

• Sponsor: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): June 17, 2010
• Last Update Submitted That Met QC Criteria: June 16, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Smoking cessation; Biomarker feedback; Childhood secondhand smoke exposure
• Other Study ID Numbers: R21