Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651684
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of a Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CanCEASE-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 25 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 ie 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 ie 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
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 25 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 ie 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 ie 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
Detailed Description:
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 162 billion and 48 thousand deaths Parental smoking has direct impacts on child health starting at in-utero stages eg 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 childrens 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 needs will mediate in part the effect of the intervention on smoking cessation
Aim 3 - Assessing whether the intervention CanCEASE HN implemented as planned is acceptable to participants and practices Hypotheses 3a both intervention and control will be acceptable to participants and practices where they are implemented 3b both the intervention and control will be delivered as planned to most participants
Aim 4 - Examining the incremental cost-effectiveness ratio in Canadian dollars per quit of CanCEASE with HN compared to care-as-usual Hypothesis 4 The intervention will have a favorable cost per quit compared to control
Participant recruitment Participants N1000 will be recruited from pediatric outpatient clinics in two healthcare centres in Montreal Canada ie General pediatrics outpatient clinic CHU Sainte-Justine Outpatient pediatric clinics Hôpital Maisonneuve-Rosemont Potential participants will initially undergo a brief pre-screening process that should take under a minute to complete It is designed for initial identification of parents who smoke using questions about data on relationship of the child with the accompanying adult smoking status of the adult and contact information This first pass prevents adults in the clinic from spending too much time in activities unrelated to their visit and prevents disruption of the work flow at the recruiting sites Pre-screening can be completed via the study website self-check-in stations in the recruitment sites where available and via the hospital appointment confirmation systems Alternatively pre-screening will be conducted by an on-site research assistant when parents come to register for an appointment Recruitment will also be done via referral by the clinical or front desk teams either by having interested individuals fill out an authorization to contact form or by scanning a QR code from posters that will be placed in the clinics such that the research team can contact potential participants to present the study obtain informed consent assess them for social risks to determine if the individual is eligible to participate in the study
Intervention CanCEASE is a parental smoking cessation intervention that facilitates referral and linkage to existing healthcare and community resources and it is available in both French and English It consists of 1 asking about smoking status 2 a self-assessment of readiness to quit and interest in available resources 3 providing advice on available services with brief motivational messages 4 assistance to quit via quit lines and text message support and 5 assistance with access to Nicotine Replacement Therapy NRT Participants will be randomized either to the control or the intervention arm of the study In both arms participants will complete three questionnaires one within the first month after recruitment then 6 and 12 months later CanCEASE will be offered after the end of each questionnaire to participants in the intervention arm of the study and after the 12-month questionnaire to control participants Control group will receive care-as-usual depending on what is typically available on site and at recruitment a resource list with freely available cessation resources with advice on how to obtain NRT Participants in the intervention group will receive in addition to CanCEASE two support sessions a health navigator HN HNs are individuals trained in specific areas of health but who do not necessarily hold a professional degree Their role is to provide assistance in ways that are complementary to what an individual receives from the healthcare system HNs can potentially enhance smoking cessation efforts by facilitating access to resources and supporting participants facing poverty-related challenges that hinder their cessation efforts Participants are expected to commit to at least two sessions with the HN the initial evaluation and follow up Session 1 will take place about 14 days after baseline questionnaire according to participant availability It will consist of an evaluation information session specification of quitting goals and specifying unmet social needs During and if needed on the days following the session the HN will facilitate participant access to resources and send support materials as needed Session 2 will occur about a month after baseline questionnaire according to participant availability At this time the HN will go over the current smoking and unmet needs status inquire about barriers and challenges and will follow-up on referrals and resources that were previously provided Participants are free to book additional HN sessions as needed for as long as they are actively taking part in the study After every session participants will receive a satisfaction survey to fill out Whenever a participant reports having quit smoking they will be invited to provide a urine sample for lab confirmation that there is no longer any nicotine in their system Urine samples will be self-collected and sent by accelerated postage
Relevance This RCT will compare in families with unmet social needs the effectiveness and cost-effectiveness of the CanCEASE intervention for parental smoking cessation with HN support in comparison to care as usual plus information on freely available cessation resources It could yield data that supports leveraging implementation of preventive primary care to improve population health
Rationale In Canada tobacco use is the greatest cause of preventable morbidity and mortality generating attributable annual health-related costs of CAD 162 billion and 48 thousand deaths Parental smoking has direct impacts on child health starting at in-utero stages eg 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 childrens 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 needs will mediate in part the effect of the intervention on smoking cessation
Aim 3 - Assessing whether the intervention CanCEASE HN implemented as planned is acceptable to participants and practices Hypotheses 3a both intervention and control will be acceptable to participants and practices where they are implemented 3b both the intervention and control will be delivered as planned to most participants
Aim 4 - Examining the incremental cost-effectiveness ratio in Canadian dollars per quit of CanCEASE with HN compared to care-as-usual Hypothesis 4 The intervention will have a favorable cost per quit compared to control
Participant recruitment Participants N1000 will be recruited from pediatric outpatient clinics in two healthcare centres in Montreal Canada ie General pediatrics outpatient clinic CHU Sainte-Justine Outpatient pediatric clinics Hôpital Maisonneuve-Rosemont Potential participants will initially undergo a brief pre-screening process that should take under a minute to complete It is designed for initial identification of parents who smoke using questions about data on relationship of the child with the accompanying adult smoking status of the adult and contact information This first pass prevents adults in the clinic from spending too much time in activities unrelated to their visit and prevents disruption of the work flow at the recruiting sites Pre-screening can be completed via the study website self-check-in stations in the recruitment sites where available and via the hospital appointment confirmation systems Alternatively pre-screening will be conducted by an on-site research assistant when parents come to register for an appointment Recruitment will also be done via referral by the clinical or front desk teams either by having interested individuals fill out an authorization to contact form or by scanning a QR code from posters that will be placed in the clinics such that the research team can contact potential participants to present the study obtain informed consent assess them for social risks to determine if the individual is eligible to participate in the study
Intervention CanCEASE is a parental smoking cessation intervention that facilitates referral and linkage to existing healthcare and community resources and it is available in both French and English It consists of 1 asking about smoking status 2 a self-assessment of readiness to quit and interest in available resources 3 providing advice on available services with brief motivational messages 4 assistance to quit via quit lines and text message support and 5 assistance with access to Nicotine Replacement Therapy NRT Participants will be randomized either to the control or the intervention arm of the study In both arms participants will complete three questionnaires one within the first month after recruitment then 6 and 12 months later CanCEASE will be offered after the end of each questionnaire to participants in the intervention arm of the study and after the 12-month questionnaire to control participants Control group will receive care-as-usual depending on what is typically available on site and at recruitment a resource list with freely available cessation resources with advice on how to obtain NRT Participants in the intervention group will receive in addition to CanCEASE two support sessions a health navigator HN HNs are individuals trained in specific areas of health but who do not necessarily hold a professional degree Their role is to provide assistance in ways that are complementary to what an individual receives from the healthcare system HNs can potentially enhance smoking cessation efforts by facilitating access to resources and supporting participants facing poverty-related challenges that hinder their cessation efforts Participants are expected to commit to at least two sessions with the HN the initial evaluation and follow up Session 1 will take place about 14 days after baseline questionnaire according to participant availability It will consist of an evaluation information session specification of quitting goals and specifying unmet social needs During and if needed on the days following the session the HN will facilitate participant access to resources and send support materials as needed Session 2 will occur about a month after baseline questionnaire according to participant availability At this time the HN will go over the current smoking and unmet needs status inquire about barriers and challenges and will follow-up on referrals and resources that were previously provided Participants are free to book additional HN sessions as needed for as long as they are actively taking part in the study After every session participants will receive a satisfaction survey to fill out Whenever a participant reports having quit smoking they will be invited to provide a urine sample for lab confirmation that there is no longer any nicotine in their system Urine samples will be self-collected and sent by accelerated postage
Relevance This RCT will compare in families with unmet social needs the effectiveness and cost-effectiveness of the CanCEASE intervention for parental smoking cessation with HN support in comparison to care as usual plus information on freely available cessation resources It could yield data that supports leveraging implementation of preventive primary care to improve population health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None