Parent eReferral to Tobacco Quitline

Parent eReferral to Tobacco Quitline in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Secondhand Smoke
• Intervention / Treatment: Behavioral: Quitline Delivered 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.

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic Quitline Referral; The electronic quitline referral will be embedded within the Tobacco Treatment CDS tool, a CDS system previously developed to help pediatricians provide smoking cessation counseling and treatment to parents who smoke, modeled off the CEASE intervention, an evidence-based approach for implementing smoking cessation treatment of parents in the pediatric setting. The parental tobacco treatment CDS tool prompts the pediatric clinician to ask the parent about smoking status and assess interest in quitting (at all well-child and acute visits), links to an electronic nicotine replacement therapy prescription for parents interested in quitting, and guides appropriate documentation. Electronic referral to the quitline will be made by clicking an automated link embedded in the tool that will send the parent smokers' names and telephone numbers (entered by the clinician) directly to the Pennsylvania (PA) Free Quitline.	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.
Other: Standard of Practice; All procedures implemented in the standard referral approach will be identical to those in the electronic referral approach with the exception of providing the telephone number for the Quitline to the parent (rather than electronic referral). The clinician workflow will be nearly the same, in that the clinician will use the link embedded in the tobacco treatment CDS tool to add the quitline to the patient's discharge paperwork (rather than automatically refer to the quitline).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Alexander Fiks, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 11, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Nicotine Replacement Therapy; Secondhand Smoke; Tobacco quitline
• Other Study ID Numbers: 16-012868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO