Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients
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|ClinicalTrials.gov Identifier: NCT01363245|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : July 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Telephone Counseling Behavioral: Fax-to-quit||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1618 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||April 2015|
Experimental: Hospital phone counseling
multisession telephone counseling by hospital/study's smoking cessation staff
Behavioral: Telephone Counseling
Telephone counseling: 7 calls over 6 weeks
Active Comparator: Fax-to-quit
Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol
referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks
- Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study [ Time Frame: 4 yrs ]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)
- Comparison of cessation outcomes by sociodemographic subgroups [ Time Frame: 4yrs ]To compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization
- Comparison of cessation rates at 6 and 12 months post-discharge [ Time Frame: 4yrs ]To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge
- Comparison of biochemically-verified smoking cessation [ Time Frame: 4 years ]To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge
- Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not [ Time Frame: 2 years ]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.
- Cost Effectiveness comparison of two smoking cessation interventions. [ Time Frame: 4 yrs ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363245
|United States, New York|
|VA New York Harbor Healthcare System|
|New York, New York, United States, 10010|
|Bellevue Hospital Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Scott E Sherman, MD, MPH||NYU School of Medicine|