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Completed

NCT Number: NCT01363245

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bellevue Hospital Center, New York, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Telephone counseling

Behavioral

Telephone counseling: 7 calls over 6 weeks

Fax-to-quit

Behavioral

referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. Comparison of biochemically-verified smoking cessation

    Time frame: 4 years

    To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 1, 2011
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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