Hospitalized Smokers

April 23, 2016 updated by: Kimber Richter, PhD, MPH, MA, University of Kansas Medical Center

Increasing Post-Discharged Follow-Up Among 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1054

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Kimber Richter, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 23, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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