NCT01305928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,054

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

February 24, 2011

Last Update Submit

April 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Enrollment in quitline services and adherence to quitline counseling sessions

    up to 6 months

  • To examine the costs to providers and participants of the intervention and control conditions

    up to 6 months

Study Arms (2)

Fax

ACTIVE COMPARATOR
Other: Fax

Warm Hand-off

EXPERIMENTAL
Other: Warm Hand-off

Interventions

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

Warm Hand-off
FaxOTHER

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

Fax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (8)

  • Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168.

  • Mussulman LM, Scheuermann TS, Faseru B, Nazir N, Richter KP. Rapid relapse to smoking following hospital discharge. Prev Med Rep. 2019 May 23;15:100891. doi: 10.1016/j.pmedr.2019.100891. eCollection 2019 Sep.

  • Liebmann EP, Scheuermann TS, Faseru B, Richter KP. Critical steps in the path to using cessation pharmacotherapy following hospital-initiated tobacco treatment. BMC Health Serv Res. 2019 Apr 24;19(1):246. doi: 10.1186/s12913-019-4059-4.

  • Scheuermann TS, Preacher KJ, Carlini BH, Bush T, Magnusson B, Nazir N, Richter KP. Predictors of engagement in post-discharge quitline counseling among hospitalized smokers. J Behav Med. 2019 Feb;42(1):139-149. doi: 10.1007/s10865-018-9951-6. Epub 2018 Jul 19.

  • Mussulman LM, Faseru B, Fitzgerald S, Nazir N, Patel V, Richter KP. A randomized, controlled pilot study of warm handoff versus fax referral for hospital-initiated smoking cessation among people living with HIV/AIDS. Addict Behav. 2018 Mar;78:205-208. doi: 10.1016/j.addbeh.2017.11.035. Epub 2017 Nov 26.

  • Richter KP, Faseru B, Shireman TI, Mussulman LM, Nazir N, Bush T, Scheuermann TS, Preacher KJ, Carlini BH, Magnusson B, Ellerbeck EF, Cramer C, Cook DJ, Martell MJ. Warm Handoff Versus Fax Referral for Linking Hospitalized Smokers to Quitlines. Am J Prev Med. 2016 Oct;51(4):587-96. doi: 10.1016/j.amepre.2016.04.006.

  • Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.

  • Richter KP, Faseru B, Mussulman LM, Ellerbeck EF, Shireman TI, Hunt JJ, Carlini BH, Preacher KJ, Ayars CL, Cook DJ. Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial. Trials. 2012 Aug 1;13:127. doi: 10.1186/1745-6215-13-127.

Study Officials

  • Kimber Richter, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2011

First Posted

March 1, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2014

Study Completion

January 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations