Clinical Response to Biomarker Documentation of Child Secondhand Smoke Exposure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01145729
First received: June 16, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose
  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).

Condition Intervention
Biomarker Feedback
Smoking Cessation
Secondhand Smoke Exposure
Provider Behavior
Behavioral: Biomarker Feedback

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Response to Biomarker Documentation of Child Secondhand Smoke Exposure

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Provider Delivery of Tobacco Treatment Services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Whether or not biomarker feedback testing of secondhand smoke will prompt providers to deliver tobacco treatment services


Secondary Outcome Measures:
  • Parent Smoking Behavior [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cannot speak English
  • No phone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145729

Locations
United States, Minnesota
University of Minnesota Department of Medicine
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Anne Joseph, University of Minnesota
ClinicalTrials.gov Identifier: NCT01145729     History of Changes
Other Study ID Numbers: R21
Study First Received: June 16, 2010
Last Updated: June 16, 2010
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Biomarker feedback
Smoking cessation
Childhood secondhand smoke exposure

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 28, 2014