Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01728038
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2012-11-13
Brief Title:
Exploring a Cessation Intervention for Smokers
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An estimated 66 million parents who smoke visit pediatric emergency departments PED annually Up to 50 of these parental smokers are from low-income raciallyethnically diverse households in which a variety of tobacco-related disparities TRD exist for both the parents and their children The PED is an ideal setting in which to address these disparities which include differences in tobacco use pediatric second hand smoke exposure SHSe quit rates access to cessation resources and morbidity such as cancer The team has conducted the only two small-scale randomized control trials RCTs investigating the efficacy of providing smoking cessation counseling to parents in the PED setting This previous research indicates that parental smokers who visit the PED are aware of the pediatric effects of SHSe motivated to quit eager to receive cessation counseling in this setting and show trends towards quitting
Parents with children who have a SHSe-related illness will have higher prolonged abstinence and point prevalence cessation rates higher motivation to quit greater number of quit attempts and lower child SHSe compared to those parents who have a child with a non-SHSe-related illness at baseline
Parents with children who have a SHSe-related illness will have higher prolonged abstinence and point prevalence cessation rates higher motivation to quit greater number of quit attempts and lower child SHSe compared to those parents who have a child with a non-SHSe-related illness at baseline
Detailed Description:
The long-range goal of my research is to test PED-based cessation interventions that are readily translated into practice in large multi-center trials However before this can occur preliminary data are needed including analyses of 1 the types of cessation intervention components that low-income parental smokers regard as essential to their cessation success 2 perceived organizational barriers to the sustainability of the intervention after the study period ends which will impede translation into practice 3 factors associated with parental cessation outcomes such as the presence of an acute SHSe-related chief complaint in the child and 4 the effect size of the intervention This data will be used to develop a parental cessation intervention that is tailored to low-income parents who are likely to quit Data from the proposed project will be used in a RO1 application to test the efficacy of this cessation intervention in a large multi-center randomized trial
The proposed developmental study will be conducted in three phases During Phase I the investigators will conduct focused interviews of PED nurses physicians and hospital administrators to explore barriers to intervention sustainability that will assist in future intervention planning During Phase II The investigators will conduct a pilot prospective trial to examine the effectiveness of this screening brief intervention and assisted referral to treatment SBIRT intervention on parental smoking cessation Equal numbers of parental smokers who bring their child to the PED for either a SHSe-related illness or non SHSe-related illness will be given a brief intervention using an adapted form of the Clinical Practice Guidelines Treating Tobacco Use and Dependence Intervention components may include brief cessation counseling using an Advise Assess and Assist approach information on SHSe in children direct connection to the Quitline QL in the ED andor free administration of nicotine replacement therapy NRT The Health Belief Model will be used to explore whether factors unique to this setting eg childs acute illness moderate the effect of the intervention on cessation outcomes Outcomes will be assessed following the intervention via phone email or text messaging based on parental preference In Phase III we will explore the feasibility of a pilot study to collect send analyze and store child saliva samples in twenty five children whose parents consent to the study The same PED-based SBIRT cessation intervention will be given to these parental smokers as in Specific Aim 2 however only English-speaking parents and parents of children who are 0-5 years of age who present to the PED with SHSe-related illnesses will be asked if they agree to have their child participate in this baseline and then 1-month after baseline saliva sample collection These saliva samples will be analyzed to assess child cotinine levels at baseline and again at 1 month after the SBIRT cessation intervention Leftover saliva will be stored and frozen indefinitely for possible future research if parents consent
The proposed developmental study will be conducted in three phases During Phase I the investigators will conduct focused interviews of PED nurses physicians and hospital administrators to explore barriers to intervention sustainability that will assist in future intervention planning During Phase II The investigators will conduct a pilot prospective trial to examine the effectiveness of this screening brief intervention and assisted referral to treatment SBIRT intervention on parental smoking cessation Equal numbers of parental smokers who bring their child to the PED for either a SHSe-related illness or non SHSe-related illness will be given a brief intervention using an adapted form of the Clinical Practice Guidelines Treating Tobacco Use and Dependence Intervention components may include brief cessation counseling using an Advise Assess and Assist approach information on SHSe in children direct connection to the Quitline QL in the ED andor free administration of nicotine replacement therapy NRT The Health Belief Model will be used to explore whether factors unique to this setting eg childs acute illness moderate the effect of the intervention on cessation outcomes Outcomes will be assessed following the intervention via phone email or text messaging based on parental preference In Phase III we will explore the feasibility of a pilot study to collect send analyze and store child saliva samples in twenty five children whose parents consent to the study The same PED-based SBIRT cessation intervention will be given to these parental smokers as in Specific Aim 2 however only English-speaking parents and parents of children who are 0-5 years of age who present to the PED with SHSe-related illnesses will be asked if they agree to have their child participate in this baseline and then 1-month after baseline saliva sample collection These saliva samples will be analyzed to assess child cotinine levels at baseline and again at 1 month after the SBIRT cessation intervention Leftover saliva will be stored and frozen indefinitely for possible future research if parents consent
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K22CA163747 | NIH | None | httpsreporternihgovquickSearch1K22CA163747 |