Smoking Cessation Peds Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02640521
• Other study ID #: 14-00742
• Status: Withdrawn
• Phase: N/A
• First received: December 16, 2015
• Last updated: December 8, 2016
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Lincoln Medical and Mental Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers		2-Month Follow Up	No
Secondary	Change in score of Asthma Control Test		2- Month Follow-Up	No
Secondary	Frequency of medication use in the prior 2 months		2- Month Follow-Up	No
Secondary	Frequency of unscheduled clinic visits		2- Month Follow-Up	No
Secondary	Frequency of Emergency Department visits for asthma in prior 2 months		2- Month Follow-Up	No
Secondary	Frequency of hospitalizations for asthma in prior 2 month		2- Month Follow-Up	No