Clinical trial NCT01363245: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients
Official title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: cost effectiveness
behavioral health counseling
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-06-01
Enrollment: 1618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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).

Primary outcomes:
measure: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study
timeFrame: 4 yrs
Secondary outcomes:
measure: Comparison of cessation outcomes by sociodemographic subgroups
timeFrame: 4yrs
measure: Comparison of cessation rates at 6 and 12 months post-discharge
timeFrame: 4yrs
measure: Comparison of biochemically-verified smoking cessation
timeFrame: 4 years
measure: Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not
timeFrame: 2 years
measure: Cost Effectiveness comparison of two smoking cessation interventions.
timeFrame: 4 yrs
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Scott E Sherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168.
citation: Cody GR, Wang B, Link AR, Sherman SE. Characteristics of Urban Inpatient Smokers With and Without Chronic Pain: Foundations for Targeted Cessation Programs. Subst Use Misuse. 2019;54(7):1138-1145. doi: 10.1080/10826084.2018.1563186. Epub 2019 Feb 1.
citation: Sherman SE, Link AR, Rogers ES, Krebs P, Ladapo JA, Shelley DR, Fang Y, Wang B, Grossman E. Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial. Am J Prev Med. 2016 Oct;51(4):566-77. doi: 10.1016/j.amepre.2016.06.023.
citation: Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
citation: Grossman E, Shelley D, Braithwaite RS, Lobach I, Goffin A, Rogers E, Sherman S. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:126. doi: 10.1186/1745-6215-13-126.