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Hospitalized Smokers

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ClinicalTrials.gov Identifier: NCT01305928
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : April 26, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Post-discharge support is a key component of effective treatment for hospitalized smokers, but very few hospitals provide it. Linking hospitalized smokers with free, proactive tobacco quitlines is an ideal way to provide supportive contact at discharge, because quitlines are effective and cost effective for smoking cessation. Many hospitals are beginning to fax-refer smokers to quitlines at discharge. Fax referral is convenient and is part of the current culture of medical communication channels. However, less than half of fax-referred smokers are successfully contacted and enrolled in quitline services. "Warm hand-off" is a novel approach to care transitions in which health care providers directly link patients that have substance abuse and mental health problems with specialists, using face-to-face or phone transfer. Warm hand-off achieves very high rates of treatment enrollment for these highly vulnerable groups.

Condition or disease Intervention/treatment
Hospitalized Smokers Other: Warm Hand-off Other: Fax

Detailed Description:
The objective if this application is to determine the relative effectiveness, and cost-effectiveness, of warm hand-off versus fax referral for linking hospitalized smokers with tobacco quitlines. This study employs a two-arm, individually randomized design. It is set in two large Kansas hospitals that have dedicated tobacco treatment interventionists on staff.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1054 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Increasing Post-Discharged Follow-Up Among Hospitalized Smokers
Study Start Date : February 2011
Primary Completion Date : April 2014
Study Completion Date : January 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Fax Other: Fax


Staff standard in-patient session: (30 minutes):

  • Assess withdrawal, need for medication change
  • Conduct assessment of smoking history, interest in quitting
  • Explore relevance, risks, rewards, and roadblocks (4Rs) related to smoking and quitting
  • Provide 2-page flyer
  • Provide medication education
  • Build plan to stay quit
  • Describe fax-referral process
  • Ask if patient requests cessation medication script on discharge
Experimental: Warm Hand-off Other: Warm Hand-off

Warm Hand-Off

Staff brief intervention and warm hand-off (5 min):

  • Assess withdrawal, need for medication change
  • Describe warm hand-off process
  • Provide 2-page flyer
  • Perform call, leave room
  • Notify patients' nurse patient is talking to quitline

Quitline session (20 min):

  • Collect minimum data set
  • Explore thoughts/feelings toward quitting
  • Provide medication education
  • Build plan to stay quit
  • Schedule next call

Staff check-back (5 min):

  • Ask patient how session went
  • Ask if patient requests cessation medication script on discharge

Outcome Measures

Primary Outcome Measures :
  1. 7-day point-prevalence, verified smoking cessation [ Time Frame: up to 6 months ]
    To test the effects of warm hand-off versus fax referral on smoking cessation

Secondary Outcome Measures :
  1. Enrollment in quitline services and adherence to quitline counseling sessions [ Time Frame: up to 6 months ]
    To test the effects of warm hand-off versus fax referral on enrollment and adherence in quitline services

  2. To examine the costs to providers and participants of the intervention and control conditions [ Time Frame: up to 6 months ]
    To examine the cost-effectiveness of the intervention

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Inclusion criteria include being residents of Kansas,
  • aged 18 years and older,
  • have smoked at least 1 cigarette in the 30 days prior to admission,
  • speak Spanish or English,
  • and wish to remain abstinent after they are discharged
  • Patients who are discharged to another facility (for long term care or rehabilitation) will be included in the trial.

Exclusion Criteria:

  • Exclusion criteria include lacking access to a telephone post-discharge,
  • acute life-threatening medical conditions (for example, cardiac arrest, acute respiratory failure, septic shock),
  • communication barriers (intubation, unable to speak or hear),
  • altered mental status,
  • severe unstable psychiatric disorder (acute psychosis),
  • terminal illness with less than a 12 month life expectancy
  • non-Kansans because residents of other states may receive quitline services from a different vendor which would confound intervention effects and make it difficult to obtain quitline adherence data
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305928

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Principal Investigator: Kimber Richter, PhD University of Kansas Medical Center