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Smoking Cessation Peds Asthma

Primary Purpose

Smoking Cessation, Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chart Reminders & New York State Quit line referral system
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Cessation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Parents

Treatment Parents

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers

Secondary Outcome Measures

Change in score of Asthma Control Test
Frequency of medication use in the prior 2 months
Frequency of unscheduled clinic visits
Frequency of Emergency Department visits for asthma in prior 2 months
Frequency of hospitalizations for asthma in prior 2 month

Full Information

First Posted
December 16, 2015
Last Updated
December 8, 2016
Sponsor
NYU Langone Health
Collaborators
Lincoln Medical and Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02640521
Brief Title
Smoking Cessation Peds Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Lincoln Medical and Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Parents
Arm Type
No Intervention
Arm Title
Treatment Parents
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chart Reminders & New York State Quit line referral system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
Time Frame
2-Month Follow Up
Secondary Outcome Measure Information:
Title
Change in score of Asthma Control Test
Time Frame
2- Month Follow-Up
Title
Frequency of medication use in the prior 2 months
Time Frame
2- Month Follow-Up
Title
Frequency of unscheduled clinic visits
Time Frame
2- Month Follow-Up
Title
Frequency of Emergency Department visits for asthma in prior 2 months
Time Frame
2- Month Follow-Up
Title
Frequency of hospitalizations for asthma in prior 2 month
Time Frame
2- Month Follow-Up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marie Bruzzese, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Smoking Cessation Peds Asthma

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