Trial Outcomes & Findings for Parent eReferral to Tobacco Quitline (NCT NCT02997735)
NCT ID: NCT02997735
Last Updated: 2019-10-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
484 participants
Primary outcome timeframe
Through study completion, up to 1 year
Results posted on
2019-10-28
Participant Flow
Participant milestones
| Measure |
eReferral
Pediatricians screened for tobacco use; 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
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
251
|
|
Overall Study
COMPLETED
|
233
|
251
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent eReferral to Tobacco Quitline
Baseline characteristics by cohort
| Measure |
eReferral
n=233 Participants
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
n=251 Participants
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.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=99 Participants
|
240 Participants
n=107 Participants
|
453 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
213 Participants
n=99 Participants
|
225 Participants
n=107 Participants
|
438 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Child age
<1
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Child age
1-5
|
89 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Child age
6-12
|
78 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Age, Customized
18-24
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Age, Customized
25-34
|
107 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
|
Age, Customized
35-49
|
87 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Age, Customized
50 or greater
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Customized
Not available
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Child age
13 or older
|
23 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Child age
Not available
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Insurance status (child)
Private
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Insurance status (child)
Medicaid
|
197 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
416 Participants
n=206 Participants
|
|
Insurance status (child)
Self-pay
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Insurance status (child)
Not available
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Asthma diagnosis (child)
No asthma
|
168 Participants
n=99 Participants
|
176 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Asthma diagnosis (child)
Asthma
|
65 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Cigarettes smoked per day (Parent)
< 10
|
138 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
303 Participants
n=206 Participants
|
|
Cigarettes smoked per day (Parent)
10 or greater
|
93 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Cigarettes smoked per day (Parent)
Not available
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Quit stage (Parent)
30 days
|
124 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
257 Participants
n=206 Participants
|
|
Quit stage (Parent)
6 months
|
76 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Quit stage (Parent)
Over 6 months
|
30 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Quit stage (Parent)
Not Available
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 1 yearProportion 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.
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=251 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Number of Parent Smokers Who Enrolled in Quitline
Not Enrolled
|
209 Participants
|
245 Participants
|
|
Number of Parent Smokers Who Enrolled in Quitline
Enrolled
|
24 Participants
|
5 Participants
|
|
Number of Parent Smokers Who Enrolled in Quitline
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearTotal number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=251 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Number of Calls With the Quitline
No calls
|
209 Participants
|
245 Participants
|
|
Number of Calls With the Quitline
One call (enrollment only)
|
7 Participants
|
0 Participants
|
|
Number of Calls With the Quitline
Two calls
|
12 Participants
|
3 Participants
|
|
Number of Calls With the Quitline
Three or more calls
|
5 Participants
|
2 Participants
|
|
Number of Calls With the Quitline
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 1 yearSelf-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=251 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Number of Parents Who Quit Smoking
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable 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.
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=251 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Study Arm
|
24 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=249 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Patient Age
<1
|
43 Participants
|
42 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Patient Age
1-5
|
89 Participants
|
82 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Patient Age
6-12
|
78 Participants
|
96 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Patient Age
13 or older
|
23 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Outcome measures
| Measure |
eReferral
n=232 Participants
Pediatricians screened for tobacco use; 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
n=248 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Parent Age
18-34
|
127 Participants
|
145 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Parent Age
35-49
|
87 Participants
|
82 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Parent Age
50 or older
|
18 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Outcome measures
| Measure |
eReferral
n=233 Participants
Pediatricians screened for tobacco use; 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
n=250 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)
No asthma
|
168 Participants
|
176 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)
Asthma
|
65 Participants
|
74 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Outcome measures
| Measure |
eReferral
n=231 Participants
Pediatricians screened for tobacco use; 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
n=247 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day
<10
|
138 Participants
|
165 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day
10 or more
|
93 Participants
|
82 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 1 yearMultivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
Outcome measures
| Measure |
eReferral
n=230 Participants
Pediatricians screened for tobacco use; 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
n=245 Participants
Pediatricians screened for tobacco use; 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.
|
|---|---|---|
|
Characteristics Associated With Successful Quitline Enrollment, Quit Stage
30 days
|
124 Participants
|
133 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Quit Stage
Less than 6 months
|
76 Participants
|
71 Participants
|
|
Characteristics Associated With Successful Quitline Enrollment, Quit Stage
6 or more months
|
30 Participants
|
41 Participants
|
Adverse Events
eReferral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Jenssen, MD MSHP
Children's Hospital of Philadelphia
Phone: 215-554-4390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place