Exploring a Cessation Intervention for Smokers (NCT01728038) | Clinical Trial Compass
CompletedNot Applicable
Exploring a Cessation Intervention for Smokers
United States230 participantsStarted 2012-03
Plain-language summary
An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED) annually. Up to 50% of these parental smokers are from low-income, racially/ethnically diverse households in which a variety of tobacco-related disparities (TRD) exist for both the parents and their children. The PED is an ideal setting in which to address these disparities, which include differences in tobacco use, pediatric second hand smoke exposure (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has conducted the only two small-scale randomized control trials (RCTs) investigating the efficacy of providing smoking cessation counseling to parents in the PED setting. This previous research indicates that parental smokers who visit the PED are aware of the pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this setting, and show trends towards quitting.
Parents with children who have a SHSe-related illness will have higher prolonged abstinence and point prevalence cessation rates, higher motivation to quit, greater number of quit attempts, and lower child SHSe compared to those parents who have a child with a non-SHSe-related illness at baseline.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1: Focused Interviews of Pediatric Emergency Department Practitioners will be conducted to assess their perceived attitudes and barriers to implementing routine tobacco screening and tobacco counseling in the pediatric emergency department.
Inclusion Criteria:
* Hospital personnel: PED medical director, Chief of Staff, Chairman of Pediatrics, quality systems specialists, informational technology specialists, PED physicians, and PED registered nurses.
Exclusion Criteria:
* Non-hospital personnel
Phase 2: Parental smokers who bring their children to the pediatric emergency department will be given brief smoking cessation counseling which includes advice on quitting, nicotine replacement therapy vouchers and direct Quitline connection.
Inclusion Criteria:
* Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 18 years old) being treated in the PED with a non-urgent complaint/condition.
Exclusion Criteria:
* Parent/Legal Guardian who is only a tobacco chewer.
* Parent/Legal Guardian who is enrolled in a smoking cessation program.
* Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other cessation treatment.
* Parent/Legal Guardian who is moving within 8 months after enrollment.
Phase 3: The same PED-based SBIRT cessation intervention will be given to these parental smokers as in Phase 2. However, parents will also be asked if they agree to have their child participate in saliva sample collection at bas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.
Timeframe: Approximately 2 years
Trial details
NCT IDNCT01728038
SponsorChildren's Hospital Medical Center, Cincinnati