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Clinical Trials/NCT02640521
NCT02640521
Withdrawn
N/A

Pilot Testing an Intervention to Increase Implementation of Evidence-based Guidelines to Achieve Smoking Cessation in Smoking Parents of Inner-city Children With Asthma

NYU Langone Health1 site in 1 countryAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
NYU Langone Health
Locations
1
Primary Endpoint
Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
Status
Withdrawn
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 2-Month Follow Up

Secondary Outcomes

  • 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 Sites (1)

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