Smoking Cessation Peds Asthma

NCT02640521 | Withdrawn

• 1 other identifier: 14-00742
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Asthma

Outcome Measures

Primary Outcomes (1)

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

  2-Month Follow Up

Secondary Outcomes (5)

• 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

Study Arms (2)

Control Parents

NO INTERVENTION

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.

Behavioral: Chart Reminders & New York State Quit line referral system

Interventions

Chart Reminders & New York State Quit line referral system BEHAVIORAL

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.

Treatment Parents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Lincoln Medical and Mental Health Center: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Asthma

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jean Marie Bruzzese, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 12, 2016

Record last verified: 2016-12

Locations

US (1)