N/A
N=765
An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT02531594 ↗Enrolled (actual)
765
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks — 4.2; 4.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SBIRT (Behavioral); HHC (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks |
4.2; 4.2 | — |
| PRIMARY Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months |
12.9; 8.3 | — |
| SECONDARY Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks |
-2; 0 | — |
| SECONDARY Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months |
-4; -2 | — |
| SECONDARY Number of Quit Attempts at 6 Weeks |
2.69; 2.22 | — |
| SECONDARY Number of Quit Attempts at 6 Months |
3.82; 2.3 | — |
| SECONDARY Readiness to Quit at 6 Weeks |
6.98; 6.46 | — |
| SECONDARY Readiness to Quit at 6 Months |
7.03; 6.77 | — |
| SECONDARY Use of Cessation Resources at 6 Weeks |
53; 0 | — |
| SECONDARY Use of Cessation Resources at 6 Months |
— | — |
Summary
This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve the child's health.
Eligibility Criteria
Inclusion Criteria:Eligible participants must:
- be > age 18;
- be accompanying a child 0-17 years of age who is presenting to the Pediatric Emergency Department with:
- a stable condition, that is, patients who are not critically ill and do not require immediate treatment and intervention by the Pediatric Emergency Department practitioner and
- a potentially Second Hand Smoke exposure related chief complaint (such as wheezing, difficulty breathing, cough) as outlined by the U.S. Surgeon General;45
- be a daily smoker;
- have currently or recently smoked inside their home;
- speak and read English, and
- have a permanent address and a working cell or landline number.
- Live within a 50 mile radius.
- Child is a non-smoker.
Exclusion Criteria: Caregivers will be excluded if
- their child has a tracheostomy or
- if the caregivers are tobacco chewers only,
- if the caregivers are using pharmacologic cessation treatment,
- or plan to move within the study period.
Data sourced from ClinicalTrials.gov (NCT02531594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.