Parent eReferral to Tobacco Quitline

NCT ID: NCT02997735

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2018-08-31

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.

Conditions

Secondhand Smoke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Quitline Delivered Treatment

Intervention Type: 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.

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).

Group Type: OTHER

Quitline Delivered Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31122792 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-012868

Identifier Type: -

Identifier Source: org_study_id