A Brief Digital Screening Tool to Address Tobacco and E-cigarette Use in Pediatric Medical Care

NCT05366790 | Completed

• 1 other identifier: 470909
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco use is the single greatest preventable cause of morbidity and mortality in Canada, accounting for 48,000 deaths and $16.2 billion annually in attributable health-related costs. Parents who smoke are often medically underserved and visit their child's doctor more than their own; 25% of all adult smokers have children seen in child healthcare. When parents quit smoking, their life expectancy is increased by more than 10 years, tobacco-related poor pregnancy outcomes are eliminated, children's risk of becoming smokers decreases 4-fold, families have more money for necessities, and children are less likely to suffer from diseases caused by tobacco smoke exposure. Despite free tobacco cessation services in every province and widespread insurance coverage of NRT, parental tobacco screening and cessation support rarely happens in pediatric care, thus there is potential for major health benefits from a routinely delivered tobacco control program to parents in this setting. The investigators will conduct a 12-month single centre, pragmatic, single-blind pilot RCT of CEASE vs. usual care of 70 parents who use cigarettes and/or vaping products whose children are seen in pediatric clinics at the CHU Sainte-Justine. A similar trial, CEASE-A will be conducted with 70 adolescents ages 14-17. Objectives:

1. 1.Perform a pilot RCT of the Clinical Effort Against Secondhand Smoke (CEASE) intervention in Canada. CEASE is an evidence-based parental smoking cessation intervention to ensure that every parent who uses cigarettes and/or nicotine vaping products and visits their child's pediatrician receives nicotine dependence treatment
2. 2.Conduct an ancillary pilot RCT of CEASE-A to deliver evidence-based support for adolescents who use tobacco and/or nicotine vaping products Outcomes include pilot process outcomes and preliminary effectiveness outcomes to assess feasibility and inform the preparation of a future large-scale RCT.

Conditions

Tobacco Use; Tobacco Cessation; Second Hand Tobacco Smoke; Smoking, Tobacco; Vaping

Keywords

Smoking cessation; second hand smoke; nicotine replacement therapy; vaping; adolescents

Outcome Measures

Primary Outcomes (6)

• Parental and adolescent recruitment rates

  The proportion of eligible participants approached who are enrolled in the study. Number of participants recruited per month.

  12 months of study follow up

• Feasibility of the intervention

  Proportion of eligible participants in each category (parents and adolescents) who declare interest in smoking/vaping cessation, who wish to be connected with smoking/vaping cessation services (quitlines), and who want to receive NRT.

  12 months of study follow up.

• Protocol fidelity

  Proportion of participants who complete the baseline questionnaire, proportion of participants who want to be connected to quitlines who are referred, and proportion who want to receive NRT and receive a prescription.

  6 months of participant follow up.

• Study retention and completion of follow-up questionnaires

  Proportion of participant that drop out or are lost to follow-up at 1, 3 and 6 months * Availability of self-reported smoking/vaping status at 1-, 3- and 6-month * Complete data available (1-, 3- and 6-month surveys) for retained participants * Availability of cotinine-testing at 1-, 3- and 6 months

  6 months of participant follow up.

• Abstinence at 6 months

  % of parental/adolescent users who report 7-day abstinence at 6-month follow-up. We will collect self-reported smoking and vaping status using the validated single items "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "Have you used a nicotine vaping product, even a puff, in the past 7 days?"

  6 months of participant follow up.

• Cotinine-confirmed quit

  Participants who self-report 7-day abstinence at 1, 3 and/or 6 months will receive a sampling kit by mail along with instructions on how to collect the urine for biochemical confirmation of smoking/vaping cessation

  6 months of participant follow up.

Secondary Outcomes (2)

• Proportion of participants reporting intent to quit smoking/vaping

  6 months of participant follow-up

• Proportion of participant reporting quit attempts at 1-, 3- and 6- months

  6 months of participant follow-up

Study Arms (2)

CEASE Intervention arm

EXPERIMENTAL

The CEASE and CEASE-A interventions are tobacco and vaping cessation interventions delivered in pediatric practices, leveraging existing healthcare and community resources. They integrate evidence-based tobacco use screening and cessation assistance into routine visits to pediatric clinics. CEASE and CEASE-A are based on the 5A's model of smoking cessation: Ask about smoking, Advise to quit, Assess readiness to quit, Assist with a quit plan and Arrange follow-up. Given that CEASE and CEASE-A are one-time interventions, "Arrange" is removed, and the fourth step "Assist" is divided into two parts: a) providing phone/text/app quit support and b) providing NRT. CEASE-A follows the same format at CEASE, but is modified slightly to address smoking and vaping in the adolescent target population

Behavioral: CEASE and CEASE-A

Control: Usual care condition

NO INTERVENTION

The control condition will be care as is usually delivered in participating clinics with the possibility of receiving direct linkage with cessation services delivered via CEASE/CEASE-A at the end of the 6-month study period. Current practice does not include routine provision of assistance for parental/adolescent smoking or e-cigarette cessation (e.g., referral to quitlines, NRT prescription).

Interventions

CEASE and CEASE-A BEHAVIORAL

CEASE (for parents) and CEASE-A (for adolescents) are evidence-based tobacco and vaping cessation interventions delivered in pediatric practices.

CEASE Intervention arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents or legal guardians of children 0-17 years old and who smoke or use nicotine vaping products. "User" will be defined as those who answer "Yes" to the screening questions:
• "Have you smoked a single cigarette, even a puff, in the past 7 days?" (smoking);
• "Have you used an e-cigarette or vaping device containing nicotine, even a puff, in the past 7 days? (vaping).
• For CEASE-A, adolescent patients aged 14-17 years who smoke or use nicotine vaping products will be considered. "Adolescent User" will be defined by those who answer "Yes" to the same screening question as parents.
• Parents will be eligible if 1) they are at least 18 years old, 2) their child is 0-17 years of age, 3) are attending a regular scheduled medical appointment, and 4) are sufficiently proficient in either French or English (able to read and answer a written questionnaire).
• Adolescents will be eligible if they are 14-17 years-old, meet criteria 3) and 4) above, and have provided informed consent (in Québec, adolescents aged 14 years can provide consent). Adolescents whose parent(s) (if present) are not agreeable to their participation will be excluded.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Pediatric Clinic of the CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Chadi N, Diamant E, Perez T, Al-Saleh A, Sylvestre MP, O'Loughlin J, Winickoff JP, Drouin O. A Brief Digital Screening and Intervention Tool for Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care in Canada: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 30;12:e47978. doi: 10.2196/47978.

  PMID: 38032712 DERIVED

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation; Tobacco Smoking; Vaping; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Smoking

Study Officials

• Olivier Drouin, MD, MSc MPH

  CHU Sainte-Justine Research Centre

  PRINCIPAL INVESTIGATOR

• Nicholas Chadi, MD, MPH

  CHU Sainte-Justine Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will be blinded to the participants' group allocation. In this pragmatic trial, pediatricians may decide to discuss smoking and/or vaping with families as part of their usual care, and participants may mention the CEASE/CEASE-A intervention during the encounter with the provider. As such, participants and physicians will not be blinded.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine

Model Details: Participants will be randomized to received either the CEASE intervention (supportive smoking cessation services) or care as usual.

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: February 22, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)