Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01363245
First received: January 31, 2011
Last updated: April 23, 2014
Last verified: April 2014

January 31, 2011
April 23, 2014
July 2011
December 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01363245 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients
Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Smoking Cessation
  • Behavioral: Telephone Counseling
    Telephone counseling: 7 calls over 6 weeks
  • Behavioral: State quit line
    referral to state smoking cessation 'quitline' for counseling - likely 2-wk duration
  • Experimental: Hospital phone counseling
    multisession telephone counseling by hospital/study's smoking cessation staff
    Intervention: Behavioral: Telephone Counseling
  • Active Comparator: Fax-to-quit
    Patients randomized to faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol)
    Intervention: Behavioral: State quit line
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1612
April 2015
December 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01363245
CHART NYU, 1U01HL10522901, 3U01HL105229-03S2
Yes
New York University School of Medicine
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
New York University School of Medicine
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP