Nicotine Dependence, Second Hand Tobacco Smoke
Conditions
Keywords
Smoking Cessation, Secondhand Smoke, Passive Smoking, Cotinine, Nicotine Replacement Products
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALClinic Quality Improvement + Behavioral Counseling
BEHAVIORALClinic Quality Improvement + Attention Control
Sponsors
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * English-speaking * parent or legal guardian of child under 11 years old who lives with him/her * daily smoker
Exclusion criteria
* non-nicotine drug dependence * psychiatric disturbance (bipolar, schizophrenia, psychosis) * pregnant * inadequate health literacy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Urine Cotinine | up to 12 months | 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. |
| Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources | up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | up to 12 months | When a participant reports smoking abstinence, we will bioverify their smoking status. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Providers referred 2949 parents to the trial: 1280 were not eligible, 598 declined participation, 702 could not be contacted. Of 369 at baseline, 369 completed self-report assessments; 42 did not complete the pre-randomization home-visit child urine (cotinine) pick-up. Thus, 327 participants were randomized between the two treatment conditions.
Participants by arm
| Arm | Count |
|---|---|
| Clinic Quality Improvement + Behavioral Counseling 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.
Clinic Quality Improvement + Behavioral Counseling | 163 |
| Clinic Quality Improvement + Attention Control 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.
Clinic Quality Improvement + Attention Control | 164 |
| Total | 327 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow-up | Lost to Follow-up | 6 | 5 |
| Treatment to End-of-treatment Assessment | Lost to Follow-up | 20 | 8 |
| Treatment to End-of-treatment Assessment | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Clinic Quality Improvement + Behavioral Counseling | Total | Clinic Quality Improvement + Attention Control |
|---|---|---|---|
| Age, Continuous | 32.74 years STANDARD_DEVIATION 7.94 | 33.31 years STANDARD_DEVIATION 8.6 | 33.88 years STANDARD_DEVIATION 9.2 |
| child age | 64.53 months STANDARD_DEVIATION 31.59 | 64.29 months STANDARD_DEVIATION 32.7 | 64.04 months STANDARD_DEVIATION 33.87 |
| child (log) cotinine | 1.17 log transformed ng/mL STANDARD_DEVIATION 0.53 | 1.21 log transformed ng/mL STANDARD_DEVIATION 0.52 | 1.24 log transformed ng/mL STANDARD_DEVIATION 0.5 |
| income below poverty level | 128 Participants | 257 Participants | 129 Participants |
| less than high school education | 43 Participants | 89 Participants | 46 Participants |
| married, living with partner | 71 Participants | 134 Participants | 63 Participants |
| parents' cigarettes per day smoked | 12.18 cigarettes smoked per day STANDARD_DEVIATION 8.92 | 11.45 cigarettes smoked per day STANDARD_DEVIATION 7.56 | 10.72 cigarettes smoked per day STANDARD_DEVIATION 5.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 134 Participants | 272 Participants | 138 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Region of Enrollment United States | 163 participants | 327 participants | 164 participants |
| Sex: Female, Male Female | 140 Participants | 273 Participants | 133 Participants |
| Sex: Female, Male Male | 23 Participants | 54 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 164 |
| other Total, other adverse events | 0 / 163 | 0 / 164 |
| serious Total, serious adverse events | 0 / 163 | 0 / 164 |
Outcome results
Primary
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
Population: The fewer number of units analyzed compared to participants analyzed relates to completion of telephone assessments for all participants, but inability to collect 5 urine samples in the Behavioral Counseling group and 2 urine samples in the Attention Control group at the post-phone assessment urine pickup at participants' homes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinic Quality Improvement + Behavioral Counseling | Child Urine Cotinine | 0.892 log transformed ng/mL | Standard Deviation 0.65 |
| Clinic Quality Improvement + Attention Control | Child Urine Cotinine | 0.891 log transformed ng/mL | Standard Deviation 0.58 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinic Quality Improvement + Behavioral Counseling | Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources | 3.8 cigarettes exposed per day | Standard Deviation 5.52 |
| Clinic Quality Improvement + Attention Control | Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources | 3.04 cigarettes exposed per day | Standard Deviation 3.84 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinic Quality Improvement + Behavioral Counseling | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 20 Participants |
| Clinic Quality Improvement + Attention Control | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 10 Participants |