Clinical trial NCT02640521: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking Cessation
Asthma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Lincoln Medical and Mental Health Center
First posted: 2015-12-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of pre-intervention patients that adhere to to Public Health Service (PHS) Guidelines from Providers
timeFrame: 2-Month Follow Up
Secondary outcomes:
measure: Change in score of Asthma Control Test
timeFrame: 2- Month Follow-Up
measure: Frequency of medication use in the prior 2 months
timeFrame: 2- Month Follow-Up
measure: Frequency of unscheduled clinic visits
timeFrame: 2- Month Follow-Up
measure: Frequency of Emergency Department visits for asthma in prior 2 months
timeFrame: 2- Month Follow-Up
measure: Frequency of hospitalizations for asthma in prior 2 month
timeFrame: 2- Month Follow-Up
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Jean Marie Bruzzese, MD
role: PRINCIPAL_INVESTIGATOR
References: