Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

Study Overview
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Brief Summary
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The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.

Detailed Description
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Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy. The primary aims are: Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral). Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective. The secondary aims are: Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients

Official Title
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Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Telephone Counseling
* Behavioral: Fax-to-quit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years smoked tobacco during the prior 30 days have an active phone number provide consent in English, Spanish or Mandarin Exclusion Criteria: Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting) are pregnant or breastfeeding are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospital phone counseling<br>multisession telephone counseling by hospital/study's smoking cessation staff | Behavioral: Telephone Counseling<br>* Telephone counseling: 7 calls over 6 weeks<br>|
| Active Comparator: Fax-to-quit<br>Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol | Behavioral: Fax-to-quit<br>* referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study | To compare the effectiveness of a phone counseling intervention (proactive multisession telephone counseling by in-hospital staff) versus control intervention ('fax-to-quit' Quitline referral) | 4 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of cessation outcomes by sociodemographic subgroups | To compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization | 4yrs | 
| Comparison of cessation rates at 6 and 12 months post-discharge | To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge | 4yrs | 
| Comparison of biochemically-verified smoking cessation | To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge | 4 years | 
| Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not | To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients. | 2 years | 
| Cost Effectiveness comparison of two smoking cessation interventions. | Evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payor perspective. Our hypotheses are that the intervention will have incremental cost-effectiveness ratios consistent with current standards of healthcare value in the United States. | 4 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cost effectiveness, behavioral health counseling