Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore the potential for directly targeting smoking cessation, regardless of motivation level, in a subsample of neonatal intensive care unit (NICU) parents with the ultimate goal of reducing secondhand smoke (SHS) in their homes.

Official Title
-----------------
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

Conditions
-----------------
Environmental Tobacco Smoke, Smoking Cessation

Intervention / Treatment
-----------------
* Drug: nicotine replacement therapy (NRT)
* Behavioral: motivational advice
* Behavioral: Quitline referral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible mothers of any age or ethnic background must have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU (ensuring time for the intervention) report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit agree to attend intervention sessions live within 50 miles of our center and have access to a telephone Exclusion Criteria: Mothers were ineligible if they met criteria for severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol were unable to read, write, and speak English were unable or unwilling to provide signed consent for participation and were unable or unwilling to meet study requirements for data collection and intervention purposes. Within the month immediately preceding the screening visit, use of any form of tobacco or nicotine products other than cigarettes (e.g., e-cigarettes, chewing tobacco, etc.) on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study Current use of NRT or enrollment (or plans to enroll) in another smoking cessation program in the next 3 months Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic blood pressure [DBP] greater than 110) History of severe cardiovascular (stroke, heart attack), kidney (e.g. chronic or acute kidney failure) or liver disease, or other unstable disease in the last 3 months History of hypersensitivity or allergic reaction to NRT or similar chemical classes or any component of these formulations (including allergy to latex)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational advice and free NRT<br> | Drug: nicotine replacement therapy (NRT)<br>* Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home<br>* Other names: nicotine patch;Behavioral: motivational advice<br>* Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol<br>|
| Active Comparator: Quitline referral<br> | Behavioral: Quitline referral<br>* Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. |  | From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization) | 
| Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. |  | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant |  | Baseline | 
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner |  | baseline | 
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) |  | baseline | 
| Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #1 (about 2 weeks post-intervention) | 
| Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #2 (about 1 month post-intervention) | 
| Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #1 (about 2 weeks post-intervention) | 
| Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #2 (about 1 month post-intervention) | 
| Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #1 (about 2 weeks post-intervention) | 
| Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts |  | at the time of follow-up visit #2 (about 1 month post-intervention) | 
| Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. |  | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) | 
| Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. |  | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) |