Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hospital phone counseling

multisession telephone counseling by hospital/study's smoking cessation staff

Group Type EXPERIMENTAL

Telephone Counseling

Intervention Type BEHAVIORAL

Telephone counseling: 7 calls over 6 weeks

Fax-to-quit

Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol

Group Type ACTIVE_COMPARATOR

Fax-to-quit

Intervention Type BEHAVIORAL

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

Interventions

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Telephone Counseling

Telephone counseling: 7 calls over 6 weeks

Intervention Type BEHAVIORAL

Fax-to-quit

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No