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Completed

NCT Number: NCT02997735

Parent eReferral to Tobacco Quitline

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.

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Key information

Conditions

Secondhand Smoke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Parent Smokers Who Enrolled in Quitline

    Time frame: Through study completion, up to 1 year

    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.

Secondary outcomes

  1. Number of Calls With the Quitline

    Time frame: Through study completion, up to 1 year

    Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline

  2. Number of Parents Who Quit Smoking

    Time frame: Through study completion, up to 1 year

    Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline

Other outcomes

  1. Characteristics Associated With Successful Quitline Enrollment, Study Arm

    Time frame: Through study completion, up to 1 year

    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.

  2. Characteristics Associated With Successful Quitline Enrollment, Patient Age

    Time frame: Through study completion, up to 1 year

    Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.

  3. Characteristics Associated With Successful Quitline Enrollment, Parent Age

    Time frame: Through study completion, up to 1 year

    Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.

  4. Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)

    Time frame: Through study completion, up to 1 year

    Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.

  5. Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day

    Time frame: Through study completion, up to 1 year

    Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.

  6. Characteristics Associated With Successful Quitline Enrollment, Quit Stage

    Time frame: Through study completion, up to 1 year

    Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Official study title

Parent eReferral to Tobacco Quitline in Primary Care

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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