Trial Outcomes & Findings for eCEASE to Support Treatment for Parental Tobacco Use (NCT NCT04974736)
NCT ID: NCT04974736
Last Updated: 2025-04-15
Results Overview
Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention \& usual care arms
COMPLETED
NA
817 participants
12-months
2025-04-15
Participant Flow
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.
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.
Unit of analysis: Practices
Participant milestones
| Measure |
eCEASE (iEHR + Navigator)
Parents in intervention practices were proactively offered eCEASE (automated delivery of Nicotine Replacement Therapy (NRT), enrollment in the quitline and SmokefreeTXT, and cessation support from a health navigator).
|
Usual Care Control
Usual care delivery in pediatric primary care offices.
|
|---|---|---|
|
Overall Study
STARTED
|
408 6
|
409 6
|
|
Overall Study
COMPLETED
|
367 6
|
368 6
|
|
Overall Study
NOT COMPLETED
|
41 0
|
41 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant chose to not share their sex.
Baseline characteristics by cohort
| Measure |
eCEASE (iEHR + Navigator)
n=408 Participants
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.
|
Usual Care Control
n=409 Participants
Usual care delivery in pediatric primary care offices.
|
Total
n=817 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=408 Participants
|
1 Participants
n=409 Participants
|
2 Participants
n=817 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
401 Participants
n=408 Participants
|
405 Participants
n=409 Participants
|
806 Participants
n=817 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=408 Participants
|
3 Participants
n=409 Participants
|
9 Participants
n=817 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 8.89 • n=408 Participants
|
35.9 years
STANDARD_DEVIATION 8.454 • n=409 Participants
|
36.17 years
STANDARD_DEVIATION 8.67 • n=817 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=407 Participants • One participant chose to not share their sex.
|
337 Participants
n=409 Participants • One participant chose to not share their sex.
|
672 Participants
n=816 Participants • One participant chose to not share their sex.
|
|
Sex: Female, Male
Male
|
72 Participants
n=407 Participants • One participant chose to not share their sex.
|
72 Participants
n=409 Participants • One participant chose to not share their sex.
|
144 Participants
n=816 Participants • One participant chose to not share their sex.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=408 Participants
|
28 Participants
n=409 Participants
|
68 Participants
n=817 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
368 Participants
n=408 Participants
|
381 Participants
n=409 Participants
|
749 Participants
n=817 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=408 Participants
|
0 Participants
n=409 Participants
|
0 Participants
n=817 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=408 Participants
|
2 Participants
n=409 Participants
|
4 Participants
n=817 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=408 Participants
|
3 Participants
n=409 Participants
|
20 Participants
n=817 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=408 Participants
|
0 Participants
n=409 Participants
|
4 Participants
n=817 Participants
|
|
Race (NIH/OMB)
Black or African American
|
165 Participants
n=408 Participants
|
179 Participants
n=409 Participants
|
344 Participants
n=817 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=408 Participants
|
204 Participants
n=409 Participants
|
377 Participants
n=817 Participants
|
|
Race (NIH/OMB)
More than one race
|
46 Participants
n=408 Participants
|
21 Participants
n=409 Participants
|
67 Participants
n=817 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=408 Participants
|
0 Participants
n=409 Participants
|
1 Participants
n=817 Participants
|
|
Region of Enrollment
United States
|
408 participants
n=408 Participants
|
409 participants
n=409 Participants
|
817 participants
n=817 Participants
|
PRIMARY outcome
Timeframe: 12-monthsParental 7-day combusted tobacco quit rates, as assessed by validated surveys, biochemically confirmed at 12 months between the intervention \& usual care arms
Outcome measures
| Measure |
eCEASE (iEHR + Navigator)
n=408 Participants
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.
|
Usual Care Control
n=409 Participants
Usual care delivery in pediatric primary care offices.
|
|---|---|---|
|
Parental Combusted Tobacco Quit Rate at 12 Months
|
34 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: Those parents who completed the follow-up survey and reported smoking a tobacco product in the last 7 days were used in the denominator.
Rates of parents' self-reported quit attempts between the intervention \& usual care control arms, assessed by validated surveys of parents
Outcome measures
| Measure |
eCEASE (iEHR + Navigator)
n=278 Participants
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.
|
Usual Care Control
n=299 Participants
Usual care delivery in pediatric primary care offices.
|
|---|---|---|
|
Rates of Parental Quit Attempts
|
205 Participants
|
189 Participants
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: Participants who completed the 12 month follow up
Rates of parental use of pharmacotherapy and Quitlines between the intervention \& usual care arms, assessed by validated surveys of parents
Outcome measures
| Measure |
eCEASE (iEHR + Navigator)
n=367 Participants
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.
|
Usual Care Control
n=368 Participants
Usual care delivery in pediatric primary care offices.
|
|---|---|---|
|
Rates of Parental Use of Pharmacotherapy or Services
Used Nicotine Replacement Therapy
|
177 Participants
|
59 Participants
|
|
Rates of Parental Use of Pharmacotherapy or Services
Enrolled in quitline
|
79 Participants
|
11 Participants
|
|
Rates of Parental Use of Pharmacotherapy or Services
Enrolled in SmokefreeTXT
|
71 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: Participants who completed follow-up
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
Outcome measures
| Measure |
eCEASE (iEHR + Navigator)
n=367 Participants
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.
|
Usual Care Control
n=368 Participants
Usual care delivery in pediatric primary care offices.
|
|---|---|---|
|
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
|
101 Participants
|
|
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
|
125 Participants
|
SECONDARY outcome
Timeframe: 12-monthsEstablish the incremental cost per quit of the iEHR + Navigator vs. usual care arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsAssess 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
Outcome measures
Outcome data not reported
Adverse Events
eCEASE (iEHR + Navigator)
Usual Care Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place