In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

Study Overview
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Brief Summary
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The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention. This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center. The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).

Detailed Description
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Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center. The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1): Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant. Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks). Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks). All participants will be given a smoking cessation leaflet.

Official Title
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In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine replacement therapy
* Behavioral: Intensive counseling
* Behavioral: Medical advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to Internal Medicine at Soroka University Medical Center. Current cigarette smokers (≥ 10 cigarettes per day) Provided written informed consent. Exclusion Criteria: Substance abuse (except for tobacco). Handicapped or bed ridden patients. Patients who don't speak Hebrew, English, Russian or Arabic. Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant. | Behavioral: Medical advice<br> <br> |
| Other: Group 2<br>Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks). | Behavioral: Intensive counseling<br> <br> |
| Other: Group 3<br>Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks). | Drug: Nicotine replacement therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome: •Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling • Smoking cessation validated by CO exhale test<5 ppm | The need for composite primary outcome based on the hypothesis that in Israel, the best supported way to quit smoking in by participating in group or personal counseling, with 50% success rate of smoking cessation. | Within six months since discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Nicotine, Spirometry, Internal medicine