Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients
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| First Received Date ICMJE | January 31, 2011 | ||||||||
| Last Updated Date | December 14, 2012 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01363245 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients | ||||||||
| Official Title ICMJE | Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients. | ||||||||
| Brief Summary | 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. 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Smoking Cessation | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Grossman E, Shelley D, Braithwaite RS, Lobach I, Goffin A, Rogers E, Sherman S. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:126. doi: 10.1186/1745-6215-13-126. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1612 | ||||||||
| Estimated Completion Date | September 2014 | ||||||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01363245 | ||||||||
| Other Study ID Numbers ICMJE | CHART NYU, 1U01HL10522901, 3U01HL105229-03S2 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | New York University School of Medicine | ||||||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | New York University School of Medicine | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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