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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Fiks, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31122792 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | eReferral | Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). |
| FG001 | Control | Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Rows may not add up to total owing to either not reported or missing data.
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| ID | Title | Description |
|---|---|---|
| BG000 | eReferral | Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Parent Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eReferral | Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Jenssen, MD MSHP | Children's Hospital of Philadelphia | 215-554-4390 | JenssenB@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2017 | May 7, 2019 | Prot_SAP_000.pdf |
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|
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 |
| 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 |
| Control |
Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Child Sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child Ethnicity | Count of Participants | Participants |
|
| Race (NIH/OMB) | Child Race | Count of Participants | Participants |
|
| Child age | Count of Participants | Participants |
|
| Insurance status (child) | Count of Participants | Participants |
|
| Asthma diagnosis (child) | Count of Participants | Participants |
|
| Cigarettes smoked per day (Parent) | Count of Participants | Participants |
|
| Quit stage (Parent) | Count of Participants | Participants |
|
Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
|
|
|
| 0 |
| 233 |
| 0 |
| 233 |
| 0 |
| 233 |
| EG001 | Control | Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral ("warm handoff") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. | 0 | 251 | 0 | 251 | 0 | 251 |
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| Two calls |
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| Three or more calls |
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| Missing |
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| 6-12 |
|
| 13 or older |
|
| Odds Ratio (OR) |
| 0.61 |
| 2-Sided |
| 95 |
| 0.18 |
| 2.12 |
6-12 years Row (<1 Ref) |
| Superiority |
| Odds Ratio (OR) | 1.82 | 2-Sided | 95 | 0.49 | 6.94 | 13 or Older Row (<1 Ref) | Superiority |
| 50 or older |
|
| Odds Ratio (OR) |
| 5.10 |
| 2-Sided |
| 95 |
| 1.46 |
| 17.32 |
50 or older Row (18-34 Ref) |
| Superiority |
| 6 or more months |
|
| Odds Ratio (OR) |
| 0.67 |
| 2-Sided |
| 95 |
| 0.15 |
| 2.21 |
| Superiority |
6 or more months Row (30 days Ref) |