Parent eReferral to Tobacco Quitline

NCT02997735 | Completed Results

• 1 other identifier: 16-012868
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondhand Smoke

Keywords

Secondhand Smoke; Nicotine Replacement Therapy; Clinical Decision Support; Tobacco quitline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Calls With the Quitline

  Through study completion, up to 1 year

• Number of Parents Who Quit Smoking

  Through study completion, up to 1 year

Other Outcomes (6)

• Characteristics Associated With Successful Quitline Enrollment, Study Arm

  Through study completion, up to 1 year

• Characteristics Associated With Successful Quitline Enrollment, Patient Age

  Through study completion, up to 1 year

• Characteristics Associated With Successful Quitline Enrollment, Parent Age

  Through study completion, up to 1 year

Study Arms (2)

Electronic Quitline Referral

EXPERIMENTAL

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

Standard of Practice

OTHER

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

Interventions

Quitline Delivered Treatment BEHAVIORAL

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.

Electronic Quitline Referral; Standard of Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 31122792 DERIVED

Results Point of Contact

• Title: Brian Jenssen, MD MSHP
• Organization: Children's Hospital of Philadelphia

JenssenB@email.chop.edu

215-554-4390

Study Officials

• Alexander Fiks, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 20, 2016
• Study Start: January 11, 2017
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)