A Randomized Controlled Trial of a Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Aim 2 - Access to resources to help with unmet social needs
研究概览
简要总结
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.
详细描述
Primary purpose: The overarching goal of the study is to address child second-hand-smoke exposure by supporting parent smoking cessation. For that purpose, the investigators designed the present investigator-blinded, randomized controlled clinical trial, to be carried out in real-world settings, in order to test the effectiveness of two combined interventions, one to promote smoking cessation and another to support parents with unmet social needs, which could be hindering their smoking cessation efforts.
Rationale: In Canada, tobacco use is the greatest cause of preventable morbidity and mortality, generating attributable annual health-related costs of CAD $16.2 billion and 48 thousand deaths. Parental smoking has direct impacts on child health, starting at in-utero stages (e.g., fetal growth restriction, premature birth, sudden infant death syndrome, and exacerbation of respiratory illnesses) and it contributes to child and adolescent smoking initiation. Yet, despite its well-known negative effects, 15% of Canadian children are exposed to household second-hand smoke. Data also indicate that parents are overall underserved in terms of medical care and see their child(ren)'s medical care providers more often than their own, but they are not frequently screened for smoking (less than 5% of visits to pediatric practices) nor do they receive any smoking cessation support. Yet, twenty-five percent of all adult smokers have children who are seen in child healthcare offices. Further, smoking and social economic status (SES) are strongly associated, such that populations with lower SES present higher proportions of tobacco use, indicating lower SES can be an obstacle to smoking cessation as well as a perpetuating factor for smoking.
Aims and hypotheses:
Aim 1 - Examining the effectiveness of the intervention (CanCEASE + HN) on smoking cessation compared to care-as-usual. Hypothesis 1: the intervention will lead to a higher proportion of quits among smoking parents than the control condition.
Aim 2 - Examining the effectiveness of the intervention (HN) on unmet social needs and, if so, does the resolution of an unmet social need mediate CanCEASE-related smoking cessation. Hypotheses: (2a) there will be a greater decrease in the prevalence of unmet social needs in the intervention vs. control arm; (2b) resolution of unmet social need(s) will mediate in part the effect of the intervention on smoking cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Pregnant patients aged ≥18 years who are parents or legal guardians of child(ren) aged 0-17 years coming in for an prenatal appointment.
- •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.
排除标准
- •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.
研究组 & 干预措施
Care-as-usual
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
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.
干预措施: CanCEASE with Health Navigator (Behavioral)
结局指标
主要结局
Aim 2 - Access to resources to help with unmet social needs
时间窗: 12 months
Percentage of participants who, at follow-up, self-report having accessed 1+ resources for each unmet social needs present at baseline
Aim 1 - 7-day abstinence
时间窗: 6 months; 12 months
Percentage of participants who self-report 7-day abstinence
Aim 1 - Smoking intensity
时间窗: 0 months; 6 months; 12 months
Average self-reported number of cigarettes per day.
Aim 1 - Cotinine-confirmed quit
时间窗: 6 months; 12 months
Urinary cotinine values below 100 ng/ml, a consensus cutoff level, biochemical confirmation of 7-day abstinence.
Aim 1 - Anabasine-confirmed quit
时间窗: 6 months; 12 months
Urinary anabasine detection allows for the differentiation between smokers and abstainers who are using NRT at concentrations below 1.2 ng/mL.
Aim 1 - Quit attempts
时间窗: 6 months; 12 months
Percentage of participants who report at least one 24-hour quit.
Aim 1 - Intent to quit
时间窗: 0 months; 6 months; 12 months
Percentage of parental smokers who are seriously considering quitting in the next six months.
Aim 2 - Resolution of social risk
时间窗: 12 months
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).
Aim 2 - Improvement in unmet social needs
时间窗: 12 months
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.
Aim 3 - Interest in resources to help them quit
时间窗: 0 months; 6 months; 12 months
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)
Aim 3 - Meaningful receipt of assistance
时间窗: 6 months; 12 months
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).
Aim 3 - Proportion or participants who had contact with HNs
时间窗: 12 months
Percentage of participants who, at follow-up, self-report having received at least one session with health navigator (Intervention arm only)
Aim 3 - Number of sessions with heath navigators
时间窗: 12 months
For each participant, number of sessions with the health navigator (Intervention arm only).
Aim 3 - Duration of sessions with heath navigators (in minutes)
时间窗: 12 months
For each participant, the average number of minutes per session health navigators spent with participants on average (Intervention arm only).
Aim 4 - Incremental cost-effectiveness ratio - intervention vs. usual care (from a healthcare system perspective)
时间窗: Through study completion, an average of 1 year
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.
次要结局
未报告次要终点
研究者
Olivier Drouin, M.D., M.Sc M.P.H.
Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine
St. Justine's Hospital