An interventional study of Clinic Quality Improvement + Behavioral Counseling and Clinic Quality Improvement + Attention Control in Second Hand Tobacco Smoke and Nicotine Dependence, sponsored by Temple University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.
Child secondhand smoke exposure (SHSe) is a significant public health problem that has been linked to asthma, acute respiratory illnesses, otitis, and SIDS, and is associated with increased risk of cancers, cardiovascular disease, and behavior problems. This project will test the effectiveness of a comprehensive multilevel intervention to reduce young children's SHSe in minority and medically underserved communities known to have the highest SHSe-related morbidity and mortality risk. First, we will provide a clinic-level quality improvement (CQI) intervention to improve the care of pediatric patients with SHSe in four pediatric clinics in North and West Philadelphia. We will then randomize eligible parents visiting the CQI clinics into either a home-level behavioral counseling intervention (CQI+BC) or a home-level attention control intervention (CQI+A). In addition to clinic-level intervention, CQI+BC provides personalized, behavioral counseling with intensive skills training and support where SHSe occurs (in the home), as well as systems navigation to facilitate access to and effective use of reimbursable nicotine replacement therapy and smoking cessation medication. Participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 327 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
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This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.
Behavioral: Clinic Quality Improvement + Behavioral Counseling
The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.
Behavioral: Clinic Quality Improvement + Attention Control
Child Urine Cotinine
Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.
Time frame: up to 12 months
Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.
Time frame: up to 12 months
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
When a participant reports smoking abstinence, we will bioverify their smoking status.
Time frame: up to 12 months
Pre-assignment clinic-level intervention and referral (recruitment): Across five pediatric primary care clinics in Philadelphia's three largest pediatric health systems (Temple University, Drexel University, and Children's Hospital of Philadelphia), 334 providers conducted the Ask, Advise, Refer clinic-level treatment implemented for this study.
| Milestone | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control |
|---|---|---|
| Started | 163 | 164 |
| Received treatment | 147 | 144 |
| Completed | 142 | 156 |
| Not completed | 21 | 8 |
| Withdrew: Lost to follow-up | 20 | 8 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control |
|---|---|---|
| Started | 142 | 156 |
| Completed | 136 | 151 |
| Not completed | 6 | 5 |
| Withdrew: Lost to follow-up | 6 | 5 |
Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.
| log transformed ng/mL | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control |
|---|---|---|
| Child Urine Cotinine | 0.892 ± 0.65 | 0.891 ± 0.58 |
Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.
| cigarettes exposed per day | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control |
|---|---|---|
| Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources | 3.8 ± 5.52 | 3.04 ± 3.84 |
When a participant reports smoking abstinence, we will bioverify their smoking status.
| Participants | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control |
|---|---|---|
| Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 20 | 10 |
Collected over 1 year (from enrollment to 12-month follow-up assessment). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clinic Quality Improvement + Behavioral Counseling | 0/163 (0%) | 0/163 (0%) | 0/163 (0%) |
| Clinic Quality Improvement + Attention Control | 0/164 (0%) | 0/164 (0%) | 0/164 (0%) |
| Age, Continuous(years) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Mean | 32.74 ± 7.94 | 33.88 ± 9.20 | 33.31 ± 8.60 |
| Sex: Female, Male(Participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Female | 140 | 133 | 273 |
| Male | 23 | 31 | 54 |
| Race (NIH/OMB)(Participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 134 | 138 | 272 |
| White | 9 | 9 | 18 |
| More than one race | 10 | 8 | 18 |
| Unknown or Not Reported | 9 | 8 | 17 |
| Region of Enrollment(participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| United States | 163 | 164 | 327 |
| married, living with partner(Participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Count of participants | 71 | 63 | 134 |
| less than high school education(Participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Count of participants | 43 | 46 | 89 |
| income below poverty level(Participants) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Count of participants | 128 | 129 | 257 |
| child age(months) | Clinic Quality Improvement + Behavioral Counseling | Clinic Quality Improvement + Attention Control | Total |
|---|---|---|---|
| Mean | 64.53 ± 31.59 | 64.04 ± 33.87 | 64.29 ± 32.70 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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