Secondhand Smoke Exposure Clinical Trial
Official title:
Effect of Using a Structured Tobacco Cessation Education Program in Resident Training on Reducing Secondhand Smoke Exposure in Children
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.
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 Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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|---|---|---|---|
| Completed |
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