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Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting

18 Years
70 Years
Open (Enrolling)

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Trial Information

Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting

The long-range goal of my research is to test PED-based cessation interventions that are
readily translated into practice in large, multi-center trials. However, before this can
occur, preliminary data are needed, including analyses of: (1) the types of cessation
intervention components that low-income parental smokers regard as essential to their
cessation success; (2) perceived organizational barriers to the sustainability of the
intervention after the study period ends which will impede translation into practice; (3)
factors associated with parental cessation outcomes such as the presence of an acute
SHSe-related chief complaint in the child; and (4) the effect size of the intervention. This
data will be used to develop a parental cessation intervention that is tailored to
low-income parents who are likely to quit. Data from the proposed project will be used in a
RO1 application to test the efficacy of this cessation intervention in a large, multi-center
randomized trial.

The proposed developmental study will be conducted in two phases. During Phase I, the
investigators will conduct focused interviews of PED nurses, physicians, and hospital
administrators to explore barriers to intervention sustainability that will assist in future
intervention planning. During Phase II, The investigators will conduct a pilot prospective
trial to examine the effectiveness of this screening, brief intervention, and assisted
referral to treatment (SBIRT) intervention on parental smoking cessation. Equal numbers of
parental smokers who bring their child to the PED for either a SHSe-related illness or non
SHSe-related illness will be given a brief intervention using an adapted form of the
Clinical Practice Guidelines: Treating Tobacco Use and Dependence. Intervention components
may include brief cessation counseling using an "Advise, Assess, and Assist" approach;
information on SHSe in children; direct connection to the Quitline (QL) in the ED; and/or
free administration of nicotine replacement therapy (NRT). The Health Belief Model will be
used to explore whether factors unique to this setting (e.g., child's acute illness)
moderate the effect of the intervention on cessation outcomes. Outcomes will be assessed
following the intervention via phone, email, or text messaging, based on parental

Phase 1: Focused Interviews of Pediatric Emergency Department Practitioners will be
conducted to assess their perceived attitudes and barriers to implementing routine tobacco
screening and tobacco counseling in the pediatric emergency department.

Inclusion Criteria:

- Hospital personnel: PED medical director, Chief of Staff, Chairman of Pediatrics,
quality systems specialists, informational technology specialists, PED physicians,
and PED registered nurses.

Exclusion Criteria:

- Non-hospital personnel

Phase 2: Parental smokers who bring their children to the pediatric emergency department
will be given brief smoking cessation counseling which includes advice on quitting,
nicotine replacement therapy vouchers and direct Quitline connection.

Inclusion Criteria:

- Parent/Legal Guardian, who are tobacco users, accompanying a child (0 to 18 years
old) being treated in the PED with a non-urgent complaint/condition.

Exclusion Criteria:

- Parent/Legal Guardian who is only a tobacco chewer.

- Parent/Legal Guardian who is enrolled in a smoking cessation program.

- Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other
cessation treatment.

- Parent/Legal Guardian who is moving within 8 months after enrollment.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.

Outcome Time Frame:

Approximately 2 years

Safety Issue:


Principal Investigator

Esther M. Mahabee-Gittens, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

October 2014

Related Keywords:

  • Asthma
  • Bronchiolitis
  • Cough
  • Ear Infection
  • Respiratory Infection
  • Wheezing
  • Asthma



Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039