Hospitalized Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kimber Richter, PhD, MPH, MA, University of Kansas
ClinicalTrials.gov Identifier:
NCT01305928
First received: February 24, 2011
Last updated: August 10, 2013
Last verified: August 2013
  Purpose

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 Intervention
Hospitalized Smokers
Other: Warm Hand-off
Other: Fax

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Increasing Post-Discharged Follow-Up Among Hospitalized Smokers

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 7-day point-prevalence, verified smoking cessation [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    To test the effects of warm hand-off versus fax referral on smoking cessation


Secondary Outcome Measures:
  • Enrollment in quitline services and adherence to quitline counseling sessions [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    To test the effects of warm hand-off versus fax referral on enrollment and adherence in quitline services

  • To examine the costs to providers and participants of the intervention and control conditions [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    To examine the cost-effectiveness of the intervention


Estimated Enrollment: 1054
Study Start Date: February 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fax Other: Fax

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305928

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

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimber Richter, PhD, MPH, MA, Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01305928     History of Changes
Other Study ID Numbers: 12345
Study First Received: February 24, 2011
Last Updated: August 10, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014