Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke

NCT06651684 | Not Yet Recruiting

• 2 other identifiers: MP-21-2025-7715506937
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

Background: The goal of this study is to address parental smoking and social adversity, which can present an obstacle for smoking cessation, in order to decrease childhood exposure to second-hand cigarette smoke. To address these factors, this study includes a smoking cessation intervention for parents and legal guardians recruited in pediatric clinics (CanCEASE), as well as the support of a Health Navigator (HN) to work with the participant towards the resolution or mitigation of unmet social needs. Participants: The research team will recruit one thousand participants from pediatric outpatient clinics within two healthcare centres in and around the city of Montreal, Canada, over the course of 2.5 years. Eligible persons are parents and legal guardians, of any sex and gender, accompanying children under 18 to their scheduled medical appointments, and who report at least one social risk in selected areas (i.e., employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy). Participants must also be 18 years old or older with sufficient proficiency in French or English to complete the interviews and questionnaires. In households in which both parents smoke, only one will be eligible to participate, but smoking cessation information will be offered to both. Families presenting at the clinic for an urgent medical issue are not eligible to participate. Intervention: Participants will be divided into control group (care as usual with CanCEASE at the end of the study period) and intervention (CanCEASE + Health navigator). All participants will complete questionnaires at Baseline, 6 and 12 months. The intervention group will receive CanCEASE at the end of each questionnaire. Controls will receive CanCEASE at 12 months. The intervention group will have the possibility to meet with the HNs and will be invited to commit to at least two sessions (i.e.: evaluation and a follow up), with the option to book more time as needed. Aims and hypotheses: Examining how effective the combination of CanCEASE with HN support is in helping parents with unmet social needs quit smoking. Investigators will also examine the effects of the intervention on status of unmet social needs, if the intervention was implemented as planned and well accepted by clinics and participants, and what is the cost of the intervention for each person who quits smoking.

Conditions

Smoking Cessation; Tobacco Dependence

Keywords

Smoking cessation; Social risk; Second hand smoke; Health navigator; Unmet social needs

Outcome Measures

Primary Outcomes (15)

• Aim 1 - 7-day abstinence

  Percentage of participants who self-report 7-day abstinence

  6 months; 12 months

• Aim 1 - Smoking intensity

  Average self-reported number of cigarettes per day.

  0 months; 6 months; 12 months

• Aim 1 - Cotinine-confirmed quit

  Urinary cotinine values below 100 ng/ml, a consensus cutoff level, biochemical confirmation of 7-day abstinence.

  6 months; 12 months

• Aim 1 - Anabasine-confirmed quit

  Urinary anabasine detection allows for the differentiation between smokers and abstainers who are using NRT at concentrations below 1.2 ng/mL.

  6 months; 12 months

• Aim 1 - Quit attempts

  Percentage of participants who report at least one 24-hour quit.

  6 months; 12 months

• Aim 1 - Intent to quit

  Percentage of parental smokers who are seriously considering quitting in the next six months.

  0 months; 6 months; 12 months

• Aim 2 - Resolution of social risk

  Percentage of participants who report resolution of one or more social risks at the end of the study. Outcome will be calculated via the comparison of Social Risk questionnaire responses at baseline and at 12 months to determine persistence of social risk (no longer reported=yes; still reported=no).

  12 months

• Aim 2 - Improvement in unmet social needs

  Self-reported improvement in unmet social need present at baseline on a 5-point Likert scale wherein: 1=Much better, 2=Somewhat better, 3=Stayed the same, 4=Somewhat worse, 5=Much worse.

  12 months

• Aim 2 - Access to resources to help with unmet social needs

  Percentage of participants who, at follow-up, self-report having accessed 1+ resources for each unmet social needs present at baseline

  12 months

• Aim 3 - Interest in resources to help them quit

  Percentage of participants who are interested in referral to quitline or text-message cessation program (SMAT) and/or prescription of pharmacotherapy to help quit (NRT)

  0 months; 6 months; 12 months

• Aim 3 - Meaningful receipt of assistance

  Percentage of participants who, at follow-up, self-report having received at least one of the following: referral to quitline or text-message cessation program (SMAT) or prescription of pharmacotherapy to help quit (NRT).

  6 months; 12 months

• Aim 3 - Proportion or participants who had contact with HNs

  Percentage of participants who, at follow-up, self-report having received at least one session with health navigator (Intervention arm only)

  12 months

• Aim 3 - Number of sessions with heath navigators

  For each participant, number of sessions with the health navigator (Intervention arm only).

  12 months

• Aim 3 - Duration of sessions with heath navigators (in minutes)

  For each participant, the average number of minutes per session health navigators spent with participants on average (Intervention arm only).

  12 months

• Aim 4 - Incremental cost-effectiveness ratio - intervention vs. usual care (from a healthcare system perspective)

  Difference in costs (intervention minus control) divided by difference in effectiveness (intervention minus control). Reported in Canadian dollars per quit. Costs will include both material and personnel costs. Personnel costs will be obtained by multiplying the total time devoted to interventions/usual care activities by national average wage rate for each type of personnel.

  Through study completion, an average of 1 year

Study Arms (2)

Care-as-usual

NO INTERVENTION

Participants assigned to this group will receive care as usually delivered in participating clinics and list of smoking cessation resources, including instructions to access Nicotine Replacement Therapy (NRT).

CanCEASE with Health Navigator

EXPERIMENTAL

Participants assigned to this arm will receive smoking cessation resources, including instructions to access Nicotine Replacement Therapy (NRT) at Baseline, 6 and 12 months. They will also have the choice to schedule support sessions with a Health Navigator, which will be an individual with lived experience related to tobacco and trained to provide support for unmet social needs.

Behavioral: CanCEASE with Health Navigator

Interventions

CanCEASE with Health Navigator BEHAVIORAL

CanCEASE is a digital intervention to identify parents who smoke, assess their motivation and willingness to quit, as well as to provide direct linkage to evidence-based smoking interventions, including effective behavioural and pharmacological resources that can be used alone or in combination. Participants will have the choice to receive CanCEASE at three timepoints (0, 6 and 12 months). CanCEASE will be combined with an offer of support sessions with a Health Navigator. Health Navigators will be research personnel hired specifically for this study and trained formally in health navigation, tobacco cessation counseling and strategies to address unmet social needs. The investigators will leverage knowledge and experience of two ongoing RCTs of HNs in pediatrics to inform training strategies.

CanCEASE with Health Navigator

Eligibility Criteria

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

You may qualify if:

• Parents or legal guardians aged ≥18 years, with child(ren) aged 0-17 years, attending a regular scheduled medical appointment in one of the study sites.
• Smokers with at least one self-reported social risk as assessed by validated screening questions on the domains employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy.
• Sufficiently proficient in French or English to understand and complete study questionnaires.

You may not qualify if:

• Families presenting at the clinic for an urgent medical issue.
• Parents without at least one social risk.
• If both parents smoke, only one parent will be eligible to participate.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (2)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Pediatric Clinic of the CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

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

Central Study Contacts

Melissa Nicolosi, B.A.

CONTACT

514 467-6535; melissa.nogueira.nicolosi.hsj@ssss.gouv.qc.ca

Tamara Perez, MSc

CONTACT

514 834-0212; tamara.perez.hsj@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• 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: Pragmatic, single-blind

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 22, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)