Hospitalized Smokers

Hospitalized Smokers Clinical Trial

Official title:

Increasing Post-Discharged Follow-Up Among Hospitalized Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305928
• Other study ID #: 12345
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: April 23, 2016
• Start date: February 2011
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1054
• Est. completion date: January 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hospitalized Smokers

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point-prevalence, verified smoking cessation	To test the effects of warm hand-off versus fax referral on smoking cessation	up to 6 months	No
Secondary	Enrollment in quitline services and adherence to quitline counseling sessions	To test the effects of warm hand-off versus fax referral on enrollment and adherence in quitline services	up to 6 months	No
Secondary	To examine the costs to providers and participants of the intervention and control conditions	To examine the cost-effectiveness of the intervention	up to 6 months	No