Second Hand Tobacco Smoke, Smoking Cessation, Tobacco Smoking
Conditions
Keywords
Family tobacco screening, Tobacco cessation
Brief summary
The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.
Interventions
BEHAVIORALiEHR + Navigator
The iEHR + Navigator intervention consists of an iEHR part of the intervention in the pediatric primary care setting which will include routine screening of families for tobacco use and treatment delivery to parents who smoke and will be linked to the child's electronic health record. The enrolled parents will also be offered support from Community Health Navigators, who will work with offices to provide customized cessation support to tobacco users, ensuring access to medications and services.
Sponsors
National Cancer Institute (NCI)
Children's Hospital of Philadelphia
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
After the intervention has been assigned at random to one practice in each of the six pairs, the intervention will be blinded at random with either the label A or the label B, and the other label will be assigned to the control practice. The statisticians will be blinded as to which of A and B is the intervention until the analyses are completed.
Intervention model description
2-arm Randomized Control Trial with a stratified cluster randomization
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. Smoker will be defined as answering yes to either of the screening questions: Have you smoked a cigarette, even a puff, in the past 7 days? and Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?
Exclusion criteria
1. Parent/legal guardian does not speak English; 2. No telephone; and 3. Prior enrollment in the study during a previous visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parental Combusted Tobacco Quit Rate at 12 Months | 12-months | Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention & usual care arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Parental Quit Attempts | 12-months | Rates of parents' self-reported quit attempts between the intervention & usual care control arms, assessed by validated surveys of parents |
| Rates of Parental Use of Pharmacotherapy or Services | 12-months | Rates of parental use of pharmacotherapy and Quitlines between the intervention & usual care arms, assessed by validated surveys of parents |
| Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars | 12-months | Rates of parental institution of smoking and vaping bans in their homes and cars between the intervention & usual care arms, assessed by validated surveys of parents |
| Incremental Cost Per Quit of the Intervention | 12-months | Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms |
| Rates of Tobacco Use Treatment Delivery | 36 months | Assess the rates of tobacco treatment delivery (NRT prescription and quitline referrals) in the iEHR + Navigator arm vs. usual care, assessed by validated surveys of parents and EHR documentation |
Countries
United States
Participant flow
Recruitment details
Cluster randomized controlled trial, conducted from July 2021 to August 2023 in Twelve Philadelphia region pediatric primary care practices within the Children's Hospital of Philadephia network. Parents who used combusted tobacco in the past seven days and attended a child's preventive healthcare visit were enrolled in the study.
Pre-assignment details
A two-arm parallel cluster randomized trial was conducted in 12 pediatric practices at Children's Hospital of Philadelphia. Practices were eligible if ≥10% of child patients had Medicaid and ≥40 daily visits. Eligible practices were paired based on size and estimated smoking rate, with six pairs selected to ensure sufficient size and representativeness. Within each pair, practices were randomly assigned to either the intervention or control group using computer-generated allocation.
Participants by arm
| Arm | Count |
|---|---|
| eCEASE (iEHR + Navigator) iEHR + Navigator: The iEHR + Navigator intervention consists of an iEHR part of the intervention in the pediatric primary care setting which will include routine screening of families for tobacco use and treatment delivery to parents who smoke and will be linked to the child's electronic health record.
The enrolled parents will also be offered support from Community Health Navigators, who will work with offices to provide customized cessation support to tobacco users, ensuring access to medications and services. | 408 |
| Usual Care Control Usual care delivery in pediatric primary care offices. | 409 |
| Total | 817 |
Baseline characteristics
| Characteristic | eCEASE (iEHR + Navigator) | Usual Care Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 401 Participants | 405 Participants | 806 Participants |
| Age, Continuous | 36.4 years STANDARD_DEVIATION 8.89 | 35.9 years STANDARD_DEVIATION 8.454 | 36.17 years STANDARD_DEVIATION 8.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 28 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 368 Participants | 381 Participants | 749 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 3 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 165 Participants | 179 Participants | 344 Participants |
| Race (NIH/OMB) More than one race | 46 Participants | 21 Participants | 67 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 173 Participants | 204 Participants | 377 Participants |
| Region of Enrollment United States | 408 participants | 409 participants | 817 participants |
| Sex: Female, Male Female | 335 Participants | 337 Participants | 672 Participants |
| Sex: Female, Male Male | 72 Participants | 72 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 408 | 0 / 409 |
| other Total, other adverse events | 0 / 408 | 0 / 409 |
| serious Total, serious adverse events | 0 / 408 | 0 / 409 |
Outcome results
Primary
Parental Combusted Tobacco Quit Rate at 12 Months
Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention & usual care arms
Time frame: 12-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| eCEASE (iEHR + Navigator) | Parental Combusted Tobacco Quit Rate at 12 Months | 34 Participants |
| Usual Care Control | Parental Combusted Tobacco Quit Rate at 12 Months | 26 Participants |
Secondary
Incremental Cost Per Quit of the Intervention
Establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms
Time frame: 12-months
Secondary
Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars
Rates of parental institution of smoking and vaping bans in their homes and cars between the intervention & usual care arms, assessed by validated surveys of parents
Time frame: 12-months
Population: Participants who completed follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eCEASE (iEHR + Navigator) | Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars | Anyone smoked at home in the past 3 months | 95 Participants |
| eCEASE (iEHR + Navigator) | Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars | Anyone smoked in the car in the past 3 months | 117 Participants |
| Usual Care Control | Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars | Anyone smoked at home in the past 3 months | 101 Participants |
| Usual Care Control | Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars | Anyone smoked in the car in the past 3 months | 125 Participants |
Secondary
Rates of Parental Quit Attempts
Rates of parents' self-reported quit attempts between the intervention & usual care control arms, assessed by validated surveys of parents
Time frame: 12-months
Population: Those parents who completed the follow-up survey and reported smoking a tobacco product in the last 7 days were used in the denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| eCEASE (iEHR + Navigator) | Rates of Parental Quit Attempts | 205 Participants |
| Usual Care Control | Rates of Parental Quit Attempts | 189 Participants |
Secondary
Rates of Parental Use of Pharmacotherapy or Services
Rates of parental use of pharmacotherapy and Quitlines between the intervention & usual care arms, assessed by validated surveys of parents
Time frame: 12-months
Population: Participants who completed the 12 month follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eCEASE (iEHR + Navigator) | Rates of Parental Use of Pharmacotherapy or Services | Used Nicotine Replacement Therapy | 177 Participants |
| eCEASE (iEHR + Navigator) | Rates of Parental Use of Pharmacotherapy or Services | Enrolled in quitline | 79 Participants |
| eCEASE (iEHR + Navigator) | Rates of Parental Use of Pharmacotherapy or Services | Enrolled in SmokefreeTXT | 71 Participants |
| Usual Care Control | Rates of Parental Use of Pharmacotherapy or Services | Used Nicotine Replacement Therapy | 59 Participants |
| Usual Care Control | Rates of Parental Use of Pharmacotherapy or Services | Enrolled in quitline | 11 Participants |
| Usual Care Control | Rates of Parental Use of Pharmacotherapy or Services | Enrolled in SmokefreeTXT | 9 Participants |
Secondary
Rates of Tobacco Use Treatment Delivery
Assess the rates of tobacco treatment delivery (NRT prescription and quitline referrals) in the iEHR + Navigator arm vs. usual care, assessed by validated surveys of parents and EHR documentation
Time frame: 36 months