Exploring a Cessation Intervention for Smokers

NCT01728038 | Completed DMC

• 2 other identifiers: CIN3819021K22CA163747
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED) annually. Up to 50% of these parental smokers are from low-income, racially/ethnically diverse households in which a variety of tobacco-related disparities (TRD) exist for both the parents and their children. The PED is an ideal setting in which to address these disparities, which include differences in tobacco use, pediatric second hand smoke exposure (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has conducted the only two small-scale randomized control trials (RCTs) investigating the efficacy of providing smoking cessation counseling to parents in the PED setting. This previous research indicates that parental smokers who visit the PED are aware of the pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this setting, and show trends towards quitting. Parents with children who have a SHSe-related illness will have higher prolonged abstinence and point prevalence cessation rates, higher motivation to quit, greater number of quit attempts, and lower child SHSe compared to those parents who have a child with a non-SHSe-related illness at baseline.

Conditions

Asthma

Keywords

Bronchiolitis; Cough; Ear Infection; Respiratory Infection; Wheezing

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 2 years

Study Arms (1)

Cessation Counseling

EXPERIMENTAL

Parental smokers will be given a brief cessation intervention consisting of counseling, nicotine replacement therapy and Quitline connection.

Behavioral: Cessation Counseling

Interventions

Cessation Counseling BEHAVIORAL

Parental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection.

Cessation Counseling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 18 years old) being treated in the PED with a non-urgent complaint/condition.
• 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.
• Phase 3: The same PED-based SBIRT cessation intervention will be given to these parental smokers as in Phase 2. However, parents will also be asked if they agree to have their child participate in saliva sample collection at baseline and at one month. Parents will also be asked if their child's leftover saliva can be stored for future research.
• Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child (0 to 5 years old) being treated in the PED with a non-urgent second hand smoke exposure related complaint/condition.
• 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
• Parent/Legal Guardian who does not speak or read English

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• Mahabee-Gittens EM, Stone L, Gordon JS. Pediatric emergency department is a promising venue for adult tobacco cessation interventions. Nicotine Tob Res. 2013 Oct;15(10):1792-3. doi: 10.1093/ntr/ntt069. Epub 2013 May 24. No abstract available.

  PMID: 23709612 RESULT

• Mahabee-Gittens EM, Khoury JC, Ho M, Stone L, Gordon JS. A smoking cessation intervention for low-income smokers in the ED. Am J Emerg Med. 2015 Aug;33(8):1056-61. doi: 10.1016/j.ajem.2015.04.058. Epub 2015 May 2.

  PMID: 25976268 RESULT

MeSH Terms

Conditions

Asthma; Bronchiolitis; Cough; Otitis; Respiratory Tract Infections; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchitis; Infections; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Esther M. Mahabee-Gittens, MD, MS

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: March 1, 2016
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

US (1)