Effect of Using a Structured Tobacco Cessation Education Program
Condition: Secondhand Smoke Exposure
Study type: Interventional

Summary: 
      This is a pilot study that aims to

        1. Evaluate the effectiveness of using a structured tobacco cessation education program,
           CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric
           residents in the outpatient continuity clinic of the pediatric residency program in
           reducing the exposure of infants to second hand smoke.

        2. Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine
           level measurement and feedback as an adjunct to counseling.
    

Detailed description: 
      The WHO estimates that half the children in the world are exposed to secondhand smoke.
      Despite recent smoke free legislation across the country, an estimated 22 percent of children
      are still exposed in their home environments. These children have increased rates of lower
      respiratory illnesses, middle ear effusion, asthma, reduced lung function and SIDS. This
      study aims to evaluate the effectiveness of using a structured tobacco cessation education
      program, CEASE (Clinical Effort against Secondhand Smoke Exposure), delivered by pediatric
      residents in the outpatient continuity clinic of a pediatric residency program in reducing
      the exposure of infants to secondhand smoke. It will also evaluate the efficacy of using a
      secondhand smoke biomarker, urine cotinine level measurement and feedback as an adjunct to
      counseling.

      Residents(and faculty) whose continuity clinic will be doing the intervention will be
      receiving tailored training on CEASE NY. The control continuity residents and faculty will
      receive no additional training. Pre and Post test questionnaires will be administered to all
      residents of both continuity clinics to test effectiveness of the teaching intervention and
      use of cotinine level on knowledge and practice. Consecutive newborns with a history of
      smoking in their home will be recruited into the study ( 22 in each group) when they first
      establish care ( between days 3 and 15), using a screening question on the nurses portion of
      the well child form. The study coordinator will obtain consent for participation from those
      screening positive for smoking in the home. Once consent is obtained the newborns will be
      randomly assigned to either intervention or control group by the study coordinator. The
      intervention group will be assigned to a CEASE trained resident for follow-up continuity
      care. The controls will be assigned to a non- CEASE trained resident for follow-up care. The
      study coordinator will log the date, agreement/non-agreement to participate, and who the
      caregiver is (parent vs. other) and to what group they have been assigned, giving them a
      unique study number. To account for the possibility of dropout, we will recruit 22 infants
      into each group. Baseline urine samples will be obtained for both groups. The intervention
      group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month
      well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention
      parents will be given feedback on the urine cotinine levels at the next well child visit. The
      control group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be
      obtained and a follow-up questionnaire will be given at the 9 month visit to both group
      parents evaluating their readiness to quit/cut down smoking and their subjective perception
      of the efficacy of resident counseling.

      Baseline urine samples will be obtained for both groups. The intervention group will receive
      specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits
      and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given
      feedback on the urine cotinine levels at the next well child visit. Control Group will
      receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a
      follow-up questionnaire will be given at the 9 month visit to both group parents evaluating
      their readiness to quit/cut down smoking and their subjective perception of the efficacy of
      resident counseling. All children will receive a small age-appropriate toy at the 12 month
      well child check as a thank you for participating in the study
    

Intervention name(s): Counseling
Intervention type(s): Behavioral
Intervention description(s): Consecutive newborns exposed to secondhand smoke will be recruited into the study and randomized to have parents receive or not receive specific counselling on harmful effects of SHS exposure. Urine cotinine will be measured at several points during the study for each group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Second hand Smoke