AsthmaNCT01728038
Exploring a Cessation Intervention for Smokers
A study testing Cessation Counseling in people with Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED) annually. Up to 50% of these parental smokers are from low-income, racially/ethnically diverse households in which a variety of tobacco-related disparities (TRD) exist for both the parents and their children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospital personnel: PED medical director, Chief of Staff, Chairman of Pediatrics, quality systems specialists, informational technology specialists, PED physicians, and PED registered nurses.
- Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 18 years old) being treated in the PED with a non-urgent complaint/condition.
- Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 5 years old) being treated in the PED with a non-urgent second hand smoke exposure related complaint/condition.
Who cannot join
- Non-hospital personnel
- Phase 2: Parental smokers who bring their children to the pediatric emergency department will be given brief smoking cessation counseling which includes advice on quitting, nicotine replacement therapy vouchers and direct Quitline connection.
- Parent/Legal Guardian who is only a tobacco chewer.
- Parent/Legal Guardian who is enrolled in a smoking cessation program.
- Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other cessation treatment.
- Parent/Legal Guardian who is moving within 8 months after enrollment.
Show all 12Show fewer
- Phase 3: The same PED-based SBIRT cessation intervention will be given to these parental smokers as in Phase 2. However, parents will also be asked if they agree to have their child participate in saliva sample collection at baseline and at one month. Parents will also be asked if their child's leftover saliva can be stored for future research.
- Parent/Legal Guardian who is only a tobacco chewer.
- Parent/Legal Guardian who is enrolled in a smoking cessation program.
- Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other cessation treatment.
- Parent/Legal Guardian who is moving within 8 months after enrollment
- Parent/Legal Guardian who does not speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting
An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED) annually. Up to 50% of these parental smokers are from low-income, racially/ethnically 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.
Read the 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; and/or free administration of nicotine replacement therapy (NRT). The Health Belief Model will be used to explore whether factors unique to this setting (e.g., child's 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.
- Conditions
- Asthma
- Being tested
- Cessation Counseling
- Keywords
- Bronchiolitis, Cough, Ear Infection, Respiratory Infection, Wheezing
- Medical subject headings
- Asthma, Bronchiolitis, Cough, Otitis, Respiratory Tract Infections, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation CounselingBehavioural
Parental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection.
| Study group | Role | What they receive |
|---|---|---|
| Cessation Counseling | Experimental | Parental smokers will be given a brief cessation intervention consisting of counseling, nicotine replacement therapy and Quitline connection. Receives: Behavioral: Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Esther M. Mahabee-Gittens, MD, MS, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728038
- Sponsor's protocol ID
- CIN381902
- Other IDs
- 1K22CA163747
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2012
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahabee-Gittens EM, Stone L, Gordon JS. Pediatric emergency department is a promising venue for adult tobacco cessation interventions. Nicotine Tob Res. 2013 Oct;15(10):1792-3. doi: 10.1093/ntr/ntt069. Epub 2013 May 24. No abstract available.
PubMed 23709612Mahabee-Gittens EM, Khoury JC, Ho M, Stone L, Gordon JS. A smoking cessation intervention for low-income smokers in the ED. Am J Emerg Med. 2015 Aug;33(8):1056-61. doi: 10.1016/j.ajem.2015.04.058. Epub 2015 May 2.
PubMed 25976268
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting
- ClinicalTrials.gov ID
- NCT01728038
- Acronym / sponsor ID
- CIN381902
- Conditions
- Asthma
- Keywords
- Bronchiolitis, Cough, Ear Infection, Respiratory Infection, Wheezing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED) annually. Up to 50% of these parental smokers are from low-income, racially/ethnically 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.
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; and/or free administration of nicotine replacement therapy (NRT). The Health Belief Model will be used to explore whether factors unique to this setting (e.g., child's 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cessation Counseling | Experimental | Behavioral: Cessation CounselingParental smokers will be given a brief cessation intervention consisting of counseling, nicotine replacement therapy and Quitline connection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hospital personnel: PED medical director, Chief of Staff, Chairman of Pediatrics, quality systems specialists, informational technology specialists, PED physicians, and PED registered nurses.
- Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 18 years old) being treated in the PED with a non-urgent complaint/condition.
- Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 5 years old) being treated in the PED with a non-urgent second hand smoke exposure related complaint/condition.
Key exclusion criteria (12 listed)
- Non-hospital personnel
- Phase 2: Parental smokers who bring their children to the pediatric emergency department will be given brief smoking cessation counseling which includes advice on quitting, nicotine replacement therapy vouchers and direct Quitline connection.
- Parent/Legal Guardian who is only a tobacco chewer.
- Parent/Legal Guardian who is enrolled in a smoking cessation program.
- Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other cessation treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation CounselingParental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection. | Behavioural | Cessation Counseling |
Primary outcome
Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.
Time frame: Approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Results publication: PubMed 23709612Mahabee-Gittens EM, Stone L, Gordon JS. Pediatric emergency department is a promising venue for adult tobacco cessation interventions. Nicotine Tob Res. 2013 Oct;15(10):1792-3. doi: 10.1093/ntr/ntt069. Epub 2013 May 24. No abstract available.
- Results publication: PubMed 25976268Mahabee-Gittens EM, Khoury JC, Ho M, Stone L, Gordon JS. A smoking cessation intervention for low-income smokers in the ED. Am J Emerg Med. 2015 Aug;33(8):1056-61. doi: 10.1016/j.ajem.2015.04.058. Epub 2015 May 2.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther M. Mahabee-Gittens, MD, MS principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation Counseling in people with Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test. (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01728038, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.