Inpatient Smoking Cessation Pilot Program

Study Overview
=================
Brief Summary
-----------------
The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.

Official Title
-----------------
Smoking Cessation Pilot Program on 9 South

Conditions
-----------------
Tobacco Use Cessation

Intervention / Treatment
-----------------
* Drug: Nicotine lozenge
* Drug: Nicotine gum
* Drug: Nicotine patch
* Other: Maryland Quitline
* Other: John Hopkins Tobacco Treatment Clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation Exclusion Criteria: Pregnant or breast feeding maternal caregivers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cessation intervention<br>All participants will receive nicotine replacement therapy and a referral to both Maryland Quitline and Johns Hopkins Tobacco Treatment Clinic for continued cessation care. Nicotine replacement therapy: Nicoderm patches, gum, lozenges Low nicotine dependence: Lozenge (2 mg) or Gum (2 mg) or Patch (7 mg) Moderate nicotine dependence: Patch (14 mg) and Lozenge (2 mg) or Gum (2 mg) High nicotine dependence: Patch (21 mg) and Lozenge (4 mg) or Gum (4 mg) Regardless of the level of nicotine addiction and subsequent dose of nicotine replacement therapy (NRT), participants of this trials are described as recipients of NRT products. | Drug: Nicotine lozenge<br>* Nicotine replacement therapy<br>Drug: Nicotine gum<br>* Nicotine replacement therapy<br>Drug: Nicotine patch<br>* Nicotine replacement therapy<br>Other: Maryland Quitline<br>* Telephone-based tobacco cessation service<br>Other: John Hopkins Tobacco Treatment Clinic<br>* Clinic-based tobacco cessation service<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-reported attempts to quit smoking | Change in caregiver self-reported tobacco cessation attempt in the past 14-days. | Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frequency of usage of outpatient tobacco cessation services | Change in frequency of caregiver self-reported usage of outpatient tobacco cessation services (Maryland Quitline or Johns Hopkins Tobacco Treatment Clinic). | Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months | 
| Change in Usage of nicotine replacement therapy products | Change in caregiver self-reported usage of nicotine replacement therapy in the past 14-days. | Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months |