Clinical trial NCT02997735: Parent eReferral to Tobacco Quitline
Official title: Parent eReferral to Tobacco Quitline in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Smoke
Keywords: Secondhand Smoke
Nicotine Replacement Therapy
Clinical Decision Support
Tobacco quitline
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2016-12-20
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Parent Smokers Who Enrolled in Quitline
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Number of Calls With the Quitline
timeFrame: Through study completion, up to 1 year
measure: Number of Parents Who Quit Smoking
timeFrame: Through study completion, up to 1 year
Other outcomes:
measure: Characteristics Associated With Successful Quitline Enrollment, Study Arm
timeFrame: Through study completion, up to 1 year
measure: Characteristics Associated With Successful Quitline Enrollment, Patient Age
timeFrame: Through study completion, up to 1 year
measure: Characteristics Associated With Successful Quitline Enrollment, Parent Age
timeFrame: Through study completion, up to 1 year
measure: Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)
timeFrame: Through study completion, up to 1 year
measure: Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day
timeFrame: Through study completion, up to 1 year
measure: Characteristics Associated With Successful Quitline Enrollment, Quit Stage
timeFrame: Through study completion, up to 1 year
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenssen BP, Muthu N, Kelly MK, Baca H, Shults J, Grundmeier RW, Fiks AG. Parent eReferral to Tobacco Quitline: A Pragmatic Randomized Trial in Pediatric Primary Care. Am J Prev Med. 2019 Jul;57(1):32-40. doi: 10.1016/j.amepre.2019.03.005. Epub 2019 May 21.