Parent eReferral to Tobacco Quitline

Secondhand Smoke Clinical Trial

Official title:

Parent eReferral to Tobacco Quitline in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997735
• Other study ID #: 16-012868
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Secondhand Smoke

Intervention

Behavioral:
• Quitline 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Through study completion, up to 1 year
Other	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.	Through study completion, up to 1 year
Other	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.	Through study completion, up to 1 year
Other	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.	Through study completion, up to 1 year
Other	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.	Through study completion, up to 1 year
Other	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.	Through study completion, up to 1 year
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.	Through study completion, up to 1 year
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	Through study completion, up to 1 year
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	Through study completion, up to 1 year