Hospitalized SmokersNCT01305928
Hospitalized Smokers
A study testing Warm Hand-off and Fax in people with Hospitalized Smokers, run by University of Kansas Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospitalized Smokers
- What is being tested?
- Warm Hand-off and Fax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,054 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospitalized Smokers
- Being tested
- Warm Hand-off, Fax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Hand-offOther
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
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
| Study group | Role | What they receive |
|---|---|---|
| Fax | Active comparator | Not described Receives: Other: Fax |
| Warm Hand-off | Experimental | Not described Receives: Other: Warm Hand-off |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point-prevalence, verified smoking cessation
To test the effects of warm hand-off versus fax referral on smoking cessation
Measured: up to 6 months
Secondary outcomes (2)
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
Measured: up to 6 months
To examine the costs to providers and participants of the intervention and control conditions
To examine the cost-effectiveness of the intervention
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hospitalized SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimber Richter, PhD, MPH, MA, University of Kansas Medical Center
- Investigators
- Kimber Richter, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305928
- Sponsor's protocol ID
- 12345
- Status last verified
- Apr 2016
- First submitted
- 24 Feb 2011
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31687769Mussulman 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.
PubMed 31193919Liebmann 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.
PubMed 31018852Scheuermann 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.
PubMed 30027388Mussulman 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.
PubMed 29216569Richter 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.
PubMed 27647059Duffy 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.
PubMed 26336372Richter 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.
PubMed 22853047
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Post-Discharged Follow-Up Among Hospitalized Smokers
- ClinicalTrials.gov ID
- NCT01305928
- Acronym / sponsor ID
- 12345
- Conditions
- Hospitalized Smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fax | Active comparator | Other: Fax |
| Warm Hand-off | Experimental | Other: Warm Hand-off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Hand-offWarm 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 | Other | Warm Hand-off |
| FaxFax 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 | Other | Fax |
Primary outcome
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
2 secondary outcomes
Enrollment in quitline services and adherence to quitline counseling sessions
Time frame: up to 6 months
To examine the costs to providers and participants of the intervention and control conditions
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Derived from this study: PubMed 31687769Triant 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.
- Derived from this study: PubMed 31193919Mussulman 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.
- Derived from this study: PubMed 31018852Liebmann 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.
- Derived from this study: PubMed 30027388Scheuermann 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.
- Derived from this study: PubMed 29216569Mussulman 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.
- Derived from this study: PubMed 27647059Richter 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.
- Derived from this study: PubMed 26336372Duffy 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.
- Derived from this study: PubMed 22853047Richter 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimber Richter, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Hand-off and Fax in people with Hospitalized Smokers, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point-prevalence, verified smoking cessation (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305928, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.