Tobacco Abuse CigarettePhase 4NCT01575145
Helping Hospitalized Patients Quit Smoking
A Phase 4 study testing Quitline facilitation intervention and Brief stop-smoking intervention in people with Tobacco Abuse Cigarette, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Abuse Cigarette
- What is being tested?
- Quitline facilitation intervention and Brief stop-smoking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Nov 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up
Who cannot join
- Current active treatment for tobacco use initiated prior to hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.
Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.
The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.
- Conditions
- Tobacco Abuse Cigarette
- Being tested
- Quitline facilitation intervention, Brief stop-smoking intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline facilitation interventionBehavioural
brief quitline facilitation intervention
Brief stop-smoking interventionBehavioural
brief review of tips to help maintain smoking abstinence, using brochure
| Study group | Role | What they receive |
|---|---|---|
| Quitline facilitation intervention | Experimental | brief quitline facilitation intervention given Receives: Behavioral: Quitline facilitation intervention |
| Stop-smoking intervention | Active comparator | brief review of tips to maintain smoking abstinence, using brochure Receives: Behavioral: Brief stop-smoking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence tobacco abstinence at 6 months after hospitalization
Measured: 6 months after hospitalization
Secondary outcomes (1)
Self-efficacy
Use of Smoking Self-Efficacy Questionnaire 12
Measured: Immediately after the delivery of the brief intervention (day of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Abuse CigaretteStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Warner, Mayo Clinic
- Investigators
- David Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575145
- Sponsor's protocol ID
- 12-002207
- Status last verified
- Jan 2016
- First submitted
- 9 Apr 2012
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nolan MB, Borah BJ, Moriarty JP, Warner DO. Association between smoking cessation and post-hospitalization healthcare costs: a matched cohort analysis. BMC Health Serv Res. 2019 Dec 2;19(1):924. doi: 10.1186/s12913-019-4777-7.
PubMed 31791307Nolan MB, Borah BJ, Moriarty JP, Warner DO. Economic Analysis of a Geographically Defined Cohort of Hospitalized Patients Who Smoke. Mayo Clin Proc. 2018 Aug;93(8):1034-1042. doi: 10.1016/j.mayocp.2018.02.022. Epub 2018 Jul 4.
PubMed 30078410
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Hospitalized Patients Quit Smoking
- ClinicalTrials.gov ID
- NCT01575145
- Acronym / sponsor ID
- 12-002207
- Conditions
- Tobacco Abuse Cigarette
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Apr 2012 (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.
The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.
Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.
The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quitline facilitation intervention | Experimental | Behavioral: Quitline facilitation interventionbrief quitline facilitation intervention given |
| Stop-smoking intervention | Active comparator | Behavioral: Brief stop-smoking interventionbrief review of tips to maintain smoking abstinence, using brochure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up
Key exclusion criteria (1 listed)
- Current active treatment for tobacco use initiated prior to hospitalization
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 |
|---|---|---|
| Quitline facilitation interventionbrief quitline facilitation intervention | Behavioural | Quitline facilitation intervention |
| Brief stop-smoking interventionbrief review of tips to help maintain smoking abstinence, using brochure | Behavioural | Stop-smoking intervention |
Primary outcome
7-day point prevalence tobacco abstinence at 6 months after hospitalization
Time frame: 6 months after hospitalization
1 secondary outcome
Self-efficacy
Time frame: Immediately after the delivery of the brief intervention (day of enrollment)
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 11 Jan 2016.
- Derived from this study: PubMed 31791307Nolan MB, Borah BJ, Moriarty JP, Warner DO. Association between smoking cessation and post-hospitalization healthcare costs: a matched cohort analysis. BMC Health Serv Res. 2019 Dec 2;19(1):924. doi: 10.1186/s12913-019-4777-7.
- Derived from this study: PubMed 30078410Nolan MB, Borah BJ, Moriarty JP, Warner DO. Economic Analysis of a Geographically Defined Cohort of Hospitalized Patients Who Smoke. Mayo Clin Proc. 2018 Aug;93(8):1034-1042. doi: 10.1016/j.mayocp.2018.02.022. Epub 2018 Jul 4.
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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.
David Warner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quitline facilitation intervention and Brief stop-smoking intervention in people with Tobacco Abuse Cigarette, run by Mayo Clinic 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 1 inclusion and 1 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 11 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 tobacco abstinence at 6 months after hospitalization (time frame: 6 months after hospitalization). 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 NCT01575145, which also lists 2 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 11 Jan 2016.