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Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

This study is currently recruiting participants.
Verified December 2012 by New York University School of Medicine
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01363245
First received: January 31, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Smoking Cessation
 Behavioral: Telephone Counseling
Behavioral: State quit line

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]
    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)

  • Cost Effectiveness comparison of two smoking cessation interventions. [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Comparison of cessation outcomes by sociodemographic subgroups [ Time Frame: 4yrs ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1612
Study Start Date: July 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Patients randomized to faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol)
 Behavioral: State quit line
referral to state smoking cessation 'quitline' for counseling - likely 2-wk duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363245

Contacts
Contact: Ellie Grossman, MD ellie.grossman@nyumc.org
Contact: Alissa Link, MPH alissa.link2@nyumc.org

Locations
United States, New York
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Ellie Grossman, MD         ellie.grossman@nyumc.org    
Sub-Investigator: Ellie Grossman, MD            
VA New York Harbor Healthcare System Recruiting
New York, New York, United States, 10010
Contact: Erin Rogers, MPH         erin.rogers2@va.gov    
Sponsors and Collaborators
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01363245     History of Changes
Other Study ID Numbers: CHART NYU, 1U01HL10522901, 3U01HL105229-03S2
Study First Received: January 31, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
cost effectiveness
behavioral health counseling

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013