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Completed

NCT Number: NCT01305928

Hospitalized Smokers

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.

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Key information

Conditions

Hospitalized Smokers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warm Hand-off

Other

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

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Increasing Post-Discharged Follow-Up Among Hospitalized Smokers

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Mar 1, 2011
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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