Smoking Cessation Peds Asthma

Not Applicable

Withdrawn

• Conditions: Smoking Cessation; Asthma
• Interventions: Behavioral: Chart Reminders & New York State Quit line referral system

• Registration Number: NCT02640521
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Parents	Chart Reminders & New York State Quit line referral system	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.

Primary Outcome Measures

Name	Time	Method
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers	2-Month Follow Up

Secondary Outcome Measures

Name	Time	Method
Change in score of Asthma Control Test	2- Month Follow-Up
Frequency of medication use in the prior 2 months	2- Month Follow-Up
Frequency of unscheduled clinic visits	2- Month Follow-Up
Frequency of Emergency Department visits for asthma in prior 2 months	2- Month Follow-Up
Frequency of hospitalizations for asthma in prior 2 month	2- Month Follow-Up

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States