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Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: Fax-to-quit
Behavioral: Telephone Counseling

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01363245
CHART NYU
1U01HL10522901 (Other Grant/Funding Number)
3U01HL105229-03S2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,618 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,618 participants in 2 patient groups

Hospital phone counseling
Experimental group
Description:
multisession telephone counseling by hospital/study's smoking cessation staff
Treatment:
Behavioral: Telephone Counseling
Fax-to-quit
Active Comparator group
Description:
Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol
Treatment:
Behavioral: Fax-to-quit

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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