Smoking CessationPhase 4NCT01289275
Smoking Cessation in Hospitalized Smokers
A Phase 4 study testing Nicotine Patches, Telephone Counseling and Brief Hospital Counseling in people with Smoking Cessation, run by University of California, San Diego at 6 sites in United States.
Trial summary
When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Patches, Telephone Counseling and Brief Hospital Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,270 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2011to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years or older
- Smoke >=6 Cigarettes per day
- English or Spanish speaking
- Valid phone number
- Valid address
- Gave consent to participate in study and evaluation
Who cannot join
- Hospital stay of less than 24 hours
- Inability to communicate orally
- Hypersensitivity to nicotine
- Pregnant
- Hospitalized for psychiatric treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Scripps Mercy - Chula Vista
Chula Vista, California, 91910
Univeristy of California, Davis
Davis, California, 95616
UCSD - Thornton Hospital
La Jolla, California, 92037
Scripps Mercy - San Diego Campus
San Diego, California, 92103
UCSD Medical Center - Hillcrest
San Diego, California, 92103
University of California, San Diego: California Smokers' Helpline
San Diego, California, 92111
About this study
When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.
The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.
Read the detailed description
Most smokers in the U.S. actually do quit smoking when hospitalized, either voluntarily or involuntarily because of hospital's nonsmoking policy. However, the majority of them return to smoking soon after their discharge from the hospital. A hospital stay, therefore, is a "teachable moment" for these patients, a good opportunity to encourage them to lead a smoke-free life after they are discharged. Research, however, has found that brief counseling provided to smokers while they are hospitalized has limited effect. The scientific data clearly show that smokers should be identified at the hospital, provided counseling, and given intensive interventions with follow up extended to 1 month post discharge. Providing such clinical services to these patients will reduce their chance of relapse to smoking and the rate of re-hospitalization. In practice though, hospitals have had difficulty providing even basic bedside counseling with a subgroup of patients, not to mention a much longer follow up post-discharge with all patients.
The proposed study aims to demonstrate that state quitlines can help bridge the gap between the recommendations from existing scientific data and the current practice by hospitals. Quitlines deliver counseling services by telephone. This is convenient for patients because they do not have to go anywhere in order to receive the counseling. Moreover, telephone counseling can be delivered proactively by the counselor.
The potential impact of this study is that if this model is proven effective in a rigorous study design, then it is likely that state quitlines across the U.S. will adopt it and start working with hospitals that are interested in using such as system. If the new JCAHO requirements get adopted, there will be a strong incentive for the hospitals to work with partners like the quitlines that can help provide follow up counseling.
With the proposed project the investigators intend to establish a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions with the rigor of a randomized design.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Patches, Telephone Counseling, Brief Hospital Counseling
- Keywords
- tobacco cessation, smoking cessation, telephone, self-help, smoking abstinence, tobacco use disorder, hospital, cardiopulmonary diseases, disparity
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchesDrug
Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
Telephone CounselingBehavioural
Up to 5 proactive counseling sessions from California Smokers' Helpline.
Brief Hospital CounselingBehavioural
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Counseling | Experimental | Up to 5 proactive counseling sessions Receives: Behavioral: Telephone Counseling; Behavioral: Brief Hospital Counseling |
| Nicotine Patches | Experimental | 8 weeks of nicotine patches Receives: Drug: Nicotine Patches; Behavioral: Brief Hospital Counseling |
| Telephone Counseling + Patches | Experimental | 5 proactive sessions, 8 weeks patches Receives: Drug: Nicotine Patches; Behavioral: Telephone Counseling; Behavioral: Brief Hospital Counseling |
| Brief hospital counseling | Active comparator | brief in hospital counseling, no proactive sessions or patches Receives: Behavioral: Brief Hospital Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 30-day Abstinence
All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.
Measured: 6-months post enrollment
Secondary outcomes (3)
Percentage of Smokers Making a 24-hour Quit Attempt
Measured: 6-months post enrollment
Self-reported Re-hospitalization
Measured: 6-months post enrollment
30-day Abstinence
All participants will receive an assessment Interview 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.
Measured: 2-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shu-Hong Zhu, University of California, San Diego
- Investigators
- Shu-Hong Zhu, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289275
- Sponsor's protocol ID
- 1U01CA159533-01
- Other IDs
- 5U01CA159533
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2011
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cummins SE, Gamst AC, Brandstein K, Seymann GB, Klonoff-Cohen H, Kirby CA, Tong EK, Chaplin E, Tedeschi GJ, Zhu SH. Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling. Am J Prev Med. 2016 Oct;51(4):578-86. doi: 10.1016/j.amepre.2016.06.021.
PubMed 27647058Duffy 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 26336372Cummins S, Zhu SH, Gamst A, Kirby C, Brandstein K, Klonoff-Cohen H, Chaplin E, Morris T, Seymann G, Lee J. Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:128. doi: 10.1186/1745-6215-13-128.
PubMed 22853197
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Hospitalized Smokers
- ClinicalTrials.gov ID
- NCT01289275
- Acronym / sponsor ID
- 1U01CA159533-01
- Conditions
- Smoking Cessation
- Keywords
- tobacco cessation, smoking cessation, telephone, self-help, smoking abstinence, tobacco use disorder, hospital, cardiopulmonary diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 29 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.
The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.
Detailed description
Most smokers in the U.S. actually do quit smoking when hospitalized, either voluntarily or involuntarily because of hospital's nonsmoking policy. However, the majority of them return to smoking soon after their discharge from the hospital. A hospital stay, therefore, is a "teachable moment" for these patients, a good opportunity to encourage them to lead a smoke-free life after they are discharged. Research, however, has found that brief counseling provided to smokers while they are hospitalized has limited effect. The scientific data clearly show that smokers should be identified at the hospital, provided counseling, and given intensive interventions with follow up extended to 1 month post discharge. Providing such clinical services to these patients will reduce their chance of relapse to smoking and the rate of re-hospitalization. In practice though, hospitals have had difficulty providing even basic bedside counseling with a subgroup of patients, not to mention a much longer follow up post-discharge with all patients.
The proposed study aims to demonstrate that state quitlines can help bridge the gap between the recommendations from existing scientific data and the current practice by hospitals. Quitlines deliver counseling services by telephone. This is convenient for patients because they do not have to go anywhere in order to receive the counseling. Moreover, telephone counseling can be delivered proactively by the counselor.
The potential impact of this study is that if this model is proven effective in a rigorous study design, then it is likely that state quitlines across the U.S. will adopt it and start working with hospitals that are interested in using such as system. If the new JCAHO requirements get adopted, there will be a strong incentive for the hospitals to work with partners like the quitlines that can help provide follow up counseling.
With the proposed project the investigators intend to establish a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions with the rigor of a randomized design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telephone Counseling | Experimental | Behavioral: Telephone Counseling, Behavioral: Brief Hospital CounselingUp to 5 proactive counseling sessions |
| Nicotine Patches | Experimental | Drug: Nicotine Patches, Behavioral: Brief Hospital Counseling8 weeks of nicotine patches |
| Telephone Counseling + Patches | Experimental | Drug: Nicotine Patches, Behavioral: Telephone Counseling, Behavioral: Brief Hospital Counseling5 proactive sessions, 8 weeks patches |
| Brief hospital counseling | Active comparator | Behavioral: Brief Hospital Counselingbrief in hospital counseling, no proactive sessions or patches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Smoke >=6 Cigarettes per day
- English or Spanish speaking
- Valid phone number
- Valid address
Key exclusion criteria (5 listed)
- Hospital stay of less than 24 hours
- Inability to communicate orally
- Hypersensitivity to nicotine
- Pregnant
- Hospitalized for psychiatric treatment
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 |
|---|---|---|
| Nicotine PatchesSubjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg. | Drug | Nicotine Patches, Telephone Counseling + Patches |
| Telephone CounselingUp to 5 proactive counseling sessions from California Smokers' Helpline. | Behavioural | Telephone Counseling, Telephone Counseling + Patches |
| Brief Hospital CounselingAll subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. | Behavioural | Brief hospital counseling, Nicotine Patches, Telephone Counseling, Telephone Counseling + Patches |
Primary outcome
Percentage of Participants With 30-day Abstinence
Time frame: 6-months post enrollment
All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.
3 secondary outcomes
Percentage of Smokers Making a 24-hour Quit Attempt
Time frame: 6-months post enrollment
Self-reported Re-hospitalization
Time frame: 6-months post enrollment
30-day Abstinence
Time frame: 2-months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27647058Cummins SE, Gamst AC, Brandstein K, Seymann GB, Klonoff-Cohen H, Kirby CA, Tong EK, Chaplin E, Tedeschi GJ, Zhu SH. Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling. Am J Prev Med. 2016 Oct;51(4):578-86. doi: 10.1016/j.amepre.2016.06.021.
- 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 22853197Cummins S, Zhu SH, Gamst A, Kirby C, Brandstein K, Klonoff-Cohen H, Chaplin E, Morris T, Seymann G, Lee J. Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:128. doi: 10.1186/1745-6215-13-128.
- Individual participant dataSharing planned: No
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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.
Shu-Hong Zhu, Ph.D. principal investigator
UCSD
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Patches, Telephone Counseling and Brief Hospital Counseling in people with Smoking Cessation, run by University of California, San Diego at 6 sites 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 6 inclusion and 5 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 29 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With 30-day Abstinence (time frame: 6-months post enrollment). 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 NCT01289275, which also lists 3 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 13 Feb 2020.