Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 1,618
- Locations
- 2
- Primary Endpoint
- Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
Hospital phone counseling
multisession telephone counseling by hospital/study's smoking cessation staff
Intervention: Telephone Counseling (Behavioral)
Fax-to-quit
Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol
Intervention: Fax-to-quit (Behavioral)
Outcomes
Primary Outcomes
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
- Comparison of biochemically-verified smoking cessation(4 years)
- Cost Effectiveness comparison of two smoking cessation interventions.(4 yrs)
- Comparison of cessation outcomes by sociodemographic subgroups(4yrs)
- Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not(2 years)
- Comparison of cessation rates at 6 and 12 months post-discharge(4yrs)