Smoking Cessation Peds Asthma

December 8, 2016 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Beyond these eligibility criteria, no exclusions will be made based on sex, ethnicity, or race of the child or parent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Parents
Active Comparator: Treatment Parents
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.
Behavioral: Chart Reminders & New York State Quit line referral system
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
Time Frame: 2-Month Follow Up
2-Month Follow Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in score of Asthma Control Test
Time Frame: 2- Month Follow-Up
2- Month Follow-Up
Frequency of medication use in the prior 2 months
Time Frame: 2- Month Follow-Up
2- Month Follow-Up
Frequency of unscheduled clinic visits
Time Frame: 2- Month Follow-Up
2- Month Follow-Up
Frequency of Emergency Department visits for asthma in prior 2 months
Time Frame: 2- Month Follow-Up
2- Month Follow-Up
Frequency of hospitalizations for asthma in prior 2 month
Time Frame: 2- Month Follow-Up
2- Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lincoln Medical and Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Marie Bruzzese, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-00742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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