NCT01363245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,618

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

3.4 years

First QC Date

January 31, 2011

Last Update Submit

July 1, 2015

Conditions

Smoking Cessation

Keywords

cost effectivenessbehavioral health counseling

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study

    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)

    4 yrs

Secondary Outcomes (5)

  • Comparison of cessation outcomes by sociodemographic subgroups

    4yrs

  • Comparison of cessation rates at 6 and 12 months post-discharge

    4yrs

  • Comparison of biochemically-verified smoking cessation

    4 years

  • Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not

    2 years

  • Cost Effectiveness comparison of two smoking cessation interventions.

    4 yrs

Study Arms (2)

Hospital phone counseling

EXPERIMENTAL

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

Behavioral: Telephone Counseling

Fax-to-quit

ACTIVE COMPARATOR

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

Behavioral: Fax-to-quit

Interventions

Telephone CounselingBEHAVIORAL

Telephone counseling: 7 calls over 6 weeks

Hospital phone counseling
Fax-to-quitBEHAVIORAL

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

Fax-to-quit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years
  • smoked tobacco during the prior 30 days
  • have an active phone number
  • provide consent in English, Spanish or Mandarin

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (5)

  • 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.

    PMID: 31687769DERIVED

  • 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.

    PMID: 30706753DERIVED

  • 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.

    PMID: 27647057DERIVED

  • 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.

    PMID: 26336372DERIVED

  • 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.

    PMID: 22852878DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Scott E Sherman, MD, MPH

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

June 1, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

US(2)