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Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01363245
Enrollment
1618
Registered
2011-06-01
Start date
2011-07-31
Completion date
2015-04-30
Last updated
2015-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

cost effectiveness, behavioral health counseling

Brief summary

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.

Detailed 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

Interventions

BEHAVIORALTelephone Counseling

Telephone counseling: 7 calls over 6 weeks

BEHAVIORALFax-to-quit

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study4 yrsTo 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

MeasureTime frameDescription
Comparison of cessation rates at 6 and 12 months post-discharge4yrsTo compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge
Comparison of biochemically-verified smoking cessation4 yearsTo compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge
Comparison of cessation outcomes by sociodemographic subgroups4yrsTo compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization
Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not2 yearsTo 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.4 yrsEvaluate 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026