Smoking CessationNCT02640521
Smoking Cessation Peds Asthma
A study testing Chart Reminders & New York State Quit line referral system in people with Smoking Cessation and Asthma, run by NYU Langone Health at 1 site in United States.
Trial summary
The overall goal of this study is to adapt and preliminarily validate an intervention based on evidence based approaches to assist smoking parents and other family members of inner-city children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing guideline-based materials used in adult… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Asthma
- What is being tested?
- Chart Reminders & New York State Quit line referral system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of a child between the ages of 4 and 12 with uncontrolled asthma, brought to one of the clinics for an asthma-related visit
- uncontrolled asthma as meeting the criteria for "not well-controlled" or "very poorly controlled" asthma: (a) score of 19 or lower on the validated Asthma Control Test (ACT)45 OR (b) any of the following in the prior 12 months: (1) 2+ courses of oral steroids; (ii) 2+ Emergency Department (ED) visits for asthma; and (iii) 1+ hospitalization for asthma.
- The parents must speak English or Spanish, and have the capacity to provide consent.
Who cannot join
- Beyond these eligibility criteria, no exclusions will be made based on sex, ethnicity, or race of the child or parent.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Pilot Testing an Intervention to Increase Implementation of Evidence-based Guidelines to Achieve Smoking Cessation in Smoking Parents of Inner-city Children With Asthma
The overall goal of this study is to adapt and preliminarily validate an intervention based on evidence based approaches to assist smoking parents and other family members of inner-city children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing guideline-based materials used in adult medicine to create a system- and provider-level intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a) procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures, and to estimate intervention effects.
Read the detailed description
Investigators will adapt guideline-based interventions used in adult medicine. The intervention consists of two system-level interventions (chart reminders to prompt providers to ask about in-home smoking and a State Quit-line referral system), and a provider-level intervention (training in the PHS Guidelines, in motivational interviewing, and on how to use the system-level intervention). Investigators will implement the study in the Bellevue Pediatric Asthma Clinic and the pediatric clinic at Lincoln Hospital using a two group (pre intervention control group / post-intervention treatment group) pilot study to test the feasibility and preliminary effects of a multi-level (i.e., system and provider) intervention. The primary outcome is provider adherence to tobacco use treatment guidelines, which will be assessed by conducting parent exit interviews with 200 smoking parents (100 pre-intervention [control group] and 100 post-intervention [treatment group]). Preliminary intervention outcomes will be collected through the parent exit interviews (i.e., baseline) and 2-month post-baseline interviews with the control and treatment parents. Providers will also be interviewed regarding their satisfaction with the intervention.
- Conditions
- Smoking Cessation, Asthma
- Being tested
- Chart Reminders & New York State Quit line referral system
- Medical subject headings
- Smoking Cessation, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart Reminders & New York State Quit line referral systemBehavioural
Investigators at New York University Medical School, Bellevue and Lincoln Hospital will work closely to (1) develop chart reminders appropriate for each of their clinics (2) to prompt providers to ask about in home smoking at every medical visit and (3) to establish a New York Quit line referral system in the pediatric practice, including clearly defined roles and responsibilities for each step. The New York State Quit line service includes proactive telephone calls with mailings of self-help material, free nicotine replacement therapy for those who qualify, and referrals to local treatment programs, ensuring that health literacy levels of materials is maximized, amending the training curriculum for providers as necessary, and modifying patient education materials that are part of the provider tool kit to focus on the negative impact of secondhand smoke.
| Study group | Role | What they receive |
|---|---|---|
| Control Parents | No intervention | Not described |
| Treatment Parents | Active comparator | Chart reminders (paper or electronic medical records, depending on clinic wishes) to prompt providers to ask about in home smoking at every medical visit; establishing a New York State Quit line referral system in the pediatric practice; and amending the training curriculum for providers and the patient education materials that are part of a provider toolkit, to focus on the negative impact of second hand smoke (SHS) on their children,and specifically, asthma outcomes. Receives: Behavioral: Chart Reminders & New York State Quit line referral system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
Measured: 2-Month Follow Up
Secondary outcomes (5)
Change in score of Asthma Control Test
Measured: 2- Month Follow-Up
Frequency of medication use in the prior 2 months
Measured: 2- Month Follow-Up
Frequency of unscheduled clinic visits
Measured: 2- Month Follow-Up
Frequency of Emergency Department visits for asthma in prior 2 months
Measured: 2- Month Follow-Up
Frequency of hospitalizations for asthma in prior 2 month
Measured: 2- Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln Medical and Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Jean Marie Bruzzese, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640521
- Sponsor's protocol ID
- 14-00742
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2015
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing an Intervention to Increase Implementation of Evidence-based Guidelines to Achieve Smoking Cessation in Smoking Parents of Inner-city Children With Asthma
- ClinicalTrials.gov ID
- NCT02640521
- Acronym / sponsor ID
- 14-00742
- Conditions
- Smoking Cessation, Asthma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Lincoln Medical and Mental Health Center
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Dec 2015 (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.
The overall goal of this study is to adapt and preliminarily validate an intervention based on evidence based approaches to assist smoking parents and other family members of inner-city children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing guideline-based materials used in adult medicine to create a system- and provider-level intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a) procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures, and to estimate intervention effects.
Detailed description
Investigators will adapt guideline-based interventions used in adult medicine. The intervention consists of two system-level interventions (chart reminders to prompt providers to ask about in-home smoking and a State Quit-line referral system), and a provider-level intervention (training in the PHS Guidelines, in motivational interviewing, and on how to use the system-level intervention). Investigators will implement the study in the Bellevue Pediatric Asthma Clinic and the pediatric clinic at Lincoln Hospital using a two group (pre intervention control group / post-intervention treatment group) pilot study to test the feasibility and preliminary effects of a multi-level (i.e., system and provider) intervention. The primary outcome is provider adherence to tobacco use treatment guidelines, which will be assessed by conducting parent exit interviews with 200 smoking parents (100 pre-intervention [control group] and 100 post-intervention [treatment group]). Preliminary intervention outcomes will be collected through the parent exit interviews (i.e., baseline) and 2-month post-baseline interviews with the control and treatment parents. Providers will also be interviewed regarding their satisfaction with the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Parents | No intervention | – |
| Treatment Parents | Active comparator | Behavioral: Chart Reminders & New York State Quit line referral systemChart reminders (paper or electronic medical records, depending on clinic wishes) to prompt providers to ask about in home smoking at every medical visit; establishing a New York State Quit line referral system in the pediatric practice; and amending the training curriculum for providers and the patient education materials that are part of a provider toolkit, to focus on the negative impact of second hand smoke (SHS) on their children,and specifically, asthma outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of a child between the ages of 4 and 12 with uncontrolled asthma, brought to one of the clinics for an asthma-related visit
- uncontrolled asthma as meeting the criteria for "not well-controlled" or "very poorly controlled" asthma: (a) score of 19 or lower on the validated Asthma Control Test (ACT)45 OR (b) any of the following in the prior 12 months: (1) 2+ courses of oral steroids; (ii) 2+ Emergency Department (ED) visits for asthma; and (iii) 1+ hospitalization for asthma.
- The parents must speak English or Spanish, and have the capacity to provide consent.
Key exclusion criteria (1 listed)
- Beyond these eligibility criteria, no exclusions will be made based on sex, ethnicity, or race of the child or parent.
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 |
|---|---|---|
| Chart Reminders & New York State Quit line referral systemInvestigators at New York University Medical School, Bellevue and Lincoln Hospital will work closely to (1) develop chart reminders appropriate for each of their clinics (2) to prompt providers to ask about in home smoking at every medical visit and (3) to establish a New York Quit line referral system in the pediatric practice, including clearly defined roles and responsibilities for each step. The New York State Quit line service includes proactive telephone calls with mailings of self-help material, free nicotine replacement therapy for those who qualify, and referrals to local treatment programs, ensuring that health literacy levels of materials is maximized, amending the training curriculum for providers as necessary, and modifying patient education materials that are part of the provider tool kit to focus on the negative impact of secondhand smoke. | Behavioural | Treatment Parents |
Primary outcome
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
Time frame: 2-Month Follow Up
5 secondary outcomes
Change in score of Asthma Control Test
Time frame: 2- Month Follow-Up
Frequency of medication use in the prior 2 months
Time frame: 2- Month Follow-Up
Frequency of unscheduled clinic visits
Time frame: 2- Month Follow-Up
Frequency of Emergency Department visits for asthma in prior 2 months
Time frame: 2- Month Follow-Up
Frequency of hospitalizations for asthma in prior 2 month
Time frame: 2- Month Follow-Up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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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.
Jean Marie Bruzzese, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chart Reminders & New York State Quit line referral system in people with Smoking Cessation and Asthma, run by NYU Langone Health 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 1 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: withdrawn, as of the sponsor's last update on 12 Dec 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers (time frame: 2-Month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2016.