Secondhand Smoke
Conditions
Keywords
Secondhand Smoke, Nicotine Replacement Therapy, Clinical Decision Support, Tobacco quitline
Brief summary
Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation quitlines are effective in helping smokers quit, but few smokers make use of their services. Electronic health record-based systems that automate referral of interested parents to quitlines through pediatric settings may increase the proportion of smokers who successfully enroll in treatment.
Detailed description
This is a randomized controlled study of electronic quitline referral compared to standard practice. Parent enrollment in the quitline will be reported to the study team by the state tobacco quitline, managed by the Pennsylvania Department of Health. This is a single site study at one large outpatient pediatric practice. Eligible study participants are parents/caregivers (hereafter referred to as parents), 18 years of age or older, who are present for the child's healthcare (both well-child and acute) visit, who smoke, and who are interested in receiving treatment through the tobacco quitline. The intervention is electronic referral to the tobacco quitline for parent smokers. The referral process will be embedded in a tobacco treatment clinical decision support (CDS) tool, created to help pediatricians provide counseling and treatment to parent smokers. The primary outcome of interest is smoker enrollment in the quitline, defined as the proportion of parent smokers identified in the clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard practice) approaches. Secondary outcomes include patient and parent demographic and behavioral factors associated with successful enrollment.
Interventions
BEHAVIORALQuitline Delivered Treatment
The PA Free quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week. Counseling is available in English and Spanish and can be provided in at least 15 additional languages through a third party. All smokers who enroll in smoking cessation treatment will receive counseling and support consistent with accepted clinical practice guidelines. This treatment includes as many as 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between calls. The timing of counseling calls will be relapse sensitive and include a call 1-2 days after the quit date, another telephone call a week after the first call, and additional calls generally occurring at 2-3-week intervals thereafter.
Sponsors
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Parent/caregiver who presents for their child's healthcare (both well-child and acute) visit * Current smoker * Interested in being referred to the tobacco quitline
Exclusion criteria
* Less than 18 years of age * Parent/caregiver who smokes but is not present during their child's healthcare visit * Not interested in referral to the tobacco quitline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Parent Smokers Who Enrolled in Quitline | Through study completion, up to 1 year | Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Calls With the Quitline | Through study completion, up to 1 year | Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline |
| Number of Parents Who Quit Smoking | Through study completion, up to 1 year | Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child) | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. |
| Characteristics Associated With Successful Quitline Enrollment, Study Arm | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment. |
| Characteristics Associated With Successful Quitline Enrollment, Quit Stage | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. |
| Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. |
| Characteristics Associated With Successful Quitline Enrollment, Patient Age | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. |
| Characteristics Associated With Successful Quitline Enrollment, Parent Age | Through study completion, up to 1 year | Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| eReferral Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). | 233 |
| Control Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (warm handoff) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. | 251 |
| Total | 484 |
Baseline characteristics
| Characteristic | eReferral | Control | Total |
|---|---|---|---|
| Age, Customized 18-24 | 20 Participants | 23 Participants | 43 Participants |
| Age, Customized 25-34 | 107 Participants | 122 Participants | 229 Participants |
| Age, Customized 35-49 | 87 Participants | 82 Participants | 169 Participants |
| Age, Customized 50 or greater | 18 Participants | 21 Participants | 39 Participants |
| Age, Customized Not available | 1 Participants | 3 Participants | 4 Participants |
| Asthma diagnosis (child) Asthma | 65 Participants | 75 Participants | 140 Participants |
| Asthma diagnosis (child) No asthma | 168 Participants | 176 Participants | 344 Participants |
| Child age <1 | 43 Participants | 42 Participants | 85 Participants |
| Child age 13 or older | 23 Participants | 29 Participants | 52 Participants |
| Child age 1-5 | 89 Participants | 82 Participants | 171 Participants |
| Child age 6-12 | 78 Participants | 96 Participants | 174 Participants |
| Child age Not available | 0 Participants | 2 Participants | 2 Participants |
| Cigarettes smoked per day (Parent) < 10 | 138 Participants | 165 Participants | 303 Participants |
| Cigarettes smoked per day (Parent) 10 or greater | 93 Participants | 82 Participants | 175 Participants |
| Cigarettes smoked per day (Parent) Not available | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 8 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 213 Participants | 240 Participants | 453 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Insurance status (child) Medicaid | 197 Participants | 219 Participants | 416 Participants |
| Insurance status (child) Not available | 0 Participants | 1 Participants | 1 Participants |
| Insurance status (child) Private | 33 Participants | 27 Participants | 60 Participants |
| Insurance status (child) Self-pay | 3 Participants | 4 Participants | 7 Participants |
| Quit stage (Parent) 30 days | 124 Participants | 133 Participants | 257 Participants |
| Quit stage (Parent) 6 months | 76 Participants | 71 Participants | 147 Participants |
| Quit stage (Parent) Not Available | 3 Participants | 6 Participants | 9 Participants |
| Quit stage (Parent) Over 6 months | 30 Participants | 41 Participants | 71 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 213 Participants | 225 Participants | 438 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 25 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 103 Participants | 118 Participants | 221 Participants |
| Sex: Female, Male Male | 130 Participants | 133 Participants | 263 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 233 | 0 / 251 |
| other Total, other adverse events | 0 / 233 | 0 / 251 |
| serious Total, serious adverse events | 0 / 233 | 0 / 251 |
Outcome results
Primary
Number of Parent Smokers Who Enrolled in Quitline
Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Number of Parent Smokers Who Enrolled in Quitline | Not Enrolled | 209 Participants |
| eReferral | Number of Parent Smokers Who Enrolled in Quitline | Enrolled | 24 Participants |
| eReferral | Number of Parent Smokers Who Enrolled in Quitline | Missing | 0 Participants |
| Control | Number of Parent Smokers Who Enrolled in Quitline | Not Enrolled | 245 Participants |
| Control | Number of Parent Smokers Who Enrolled in Quitline | Enrolled | 5 Participants |
| Control | Number of Parent Smokers Who Enrolled in Quitline | Missing | 1 Participants |
Secondary
Number of Calls With the Quitline
Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline
Time frame: Through study completion, up to 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Number of Calls With the Quitline | One call (enrollment only) | 7 Participants |
| eReferral | Number of Calls With the Quitline | Three or more calls | 5 Participants |
| eReferral | Number of Calls With the Quitline | Two calls | 12 Participants |
| eReferral | Number of Calls With the Quitline | Missing | 0 Participants |
| eReferral | Number of Calls With the Quitline | No calls | 209 Participants |
| Control | Number of Calls With the Quitline | Missing | 1 Participants |
| Control | Number of Calls With the Quitline | No calls | 245 Participants |
| Control | Number of Calls With the Quitline | One call (enrollment only) | 0 Participants |
| Control | Number of Calls With the Quitline | Two calls | 3 Participants |
| Control | Number of Calls With the Quitline | Three or more calls | 2 Participants |
Secondary
Number of Parents Who Quit Smoking
Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline
Time frame: Through study completion, up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| eReferral | Number of Parents Who Quit Smoking | 1 Participants |
| Control | Number of Parents Who Quit Smoking | 0 Participants |
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child) | No asthma | 168 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child) | Asthma | 65 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child) | No asthma | 176 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child) | Asthma | 74 Participants |
p-value: 0.8595% CI: [0.4, 2.8]Chi-squared
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day | <10 | 138 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day | 10 or more | 93 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day | <10 | 165 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day | 10 or more | 82 Participants |
p-value: 0.08695% CI: [0.9, 6.5]Chi-squared
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Parent Age
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 18-34 | 127 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 35-49 | 87 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 50 or older | 18 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 18-34 | 145 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 35-49 | 82 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Parent Age | 50 or older | 21 Participants |
p-value: 0.02895% CI: [0.92, 6.5]Chi-squared
95% CI: [1.46, 17.32]
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Patient Age
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Patient Age | <1 | 43 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 1-5 | 89 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 6-12 | 78 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 13 or older | 23 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 13 or older | 29 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Patient Age | <1 | 42 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 6-12 | 96 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Patient Age | 1-5 | 82 Participants |
p-value: 0.1595% CI: [0.13, 1.72]Chi-squared
95% CI: [0.18, 2.12]
95% CI: [0.49, 6.94]
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Quit Stage
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | 30 days | 124 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | 6 or more months | 30 Participants |
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | Less than 6 months | 76 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | 30 days | 133 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | Less than 6 months | 71 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Quit Stage | 6 or more months | 41 Participants |
p-value: 0.3595% CI: [0.15, 1.27]Chi-squared
95% CI: [0.15, 2.21]
Other Pre-specified
Characteristics Associated With Successful Quitline Enrollment, Study Arm
Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.
Time frame: Through study completion, up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| eReferral | Characteristics Associated With Successful Quitline Enrollment, Study Arm | 24 Participants |
| Control | Characteristics Associated With Successful Quitline Enrollment, Study Arm | 5 Participants |
p-value: <0.00195% CI: [2.81, 27.9]Chi-squared