Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Fax-to-quit; Behavioral: Telephone Counseling

• Registration Number: NCT01363245
• Lead Sponsor: NYU Langone Health

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

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Study Start: 2011-07
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1618

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fax-to-quit	Fax-to-quit	Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol
Hospital phone counseling	Telephone Counseling	multisession telephone counseling by hospital/study's smoking cessation staff

Primary Outcome Measures

Name	Time	Method
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study	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 Outcome Measures

Name	Time	Method
Cost Effectiveness comparison of two smoking cessation interventions.	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.
Comparison of cessation rates at 6 and 12 months post-discharge	4yrs	To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge
Comparison of biochemically-verified smoking cessation	4 years	To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge
Comparison of cessation outcomes by sociodemographic subgroups	4yrs	To 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 not	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.

Trial Locations

Locations (2)

VA New York Harbor Healthcare System; 🇺🇸 New York, New York, United States

Bellevue Hospital Center; 🇺🇸 New York, New York, United States