Smoking CessationNCT01363245
Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients
A study testing Telephone Counseling and Fax-to-quit in people with Smoking Cessation, run by NYU Langone Health at 2 sites in United States.
Trial summary
The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals. 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?
- Telephone Counseling and Fax-to-quit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,618 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Apr 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- smoked tobacco during the prior 30 days
- have an active phone number
- provide consent in English, Spanish or Mandarin
Who cannot join
- Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting)
- are pregnant or breastfeeding
- are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA New York Harbor Healthcare System
New York, New York, 10010
Bellevue Hospital Center
New York, New York, 10016
About this study
Official title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.
Read the detailed description
Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy.
The primary aims are:
Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral).
Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective.
The secondary aims are:
Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients
- Conditions
- Smoking Cessation
- Being tested
- Telephone Counseling, Fax-to-quit
- Keywords
- cost effectiveness, behavioral health counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingBehavioural
Telephone counseling: 7 calls over 6 weeks
Fax-to-quitBehavioural
referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hospital phone counseling | Experimental | multisession telephone counseling by hospital/study's smoking cessation staff Receives: Behavioral: Telephone Counseling |
| Fax-to-quit | Active comparator | Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol Receives: Behavioral: Fax-to-quit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study
To compare the effectiveness of a phone counseling intervention (proactive multisession telephone counseling by in-hospital staff) versus control intervention ('fax-to-quit' Quitline referral)
Measured: 4 yrs
Secondary outcomes (5)
Comparison of cessation outcomes by sociodemographic subgroups
To compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization
Measured: 4yrs
Comparison of cessation rates at 6 and 12 months post-discharge
To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge
Measured: 4yrs
Comparison of biochemically-verified smoking cessation
To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge
Measured: 4 years
Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not
To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients.
Measured: 2 years
Cost Effectiveness comparison of two smoking cessation interventions.
Evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payor perspective. Our hypotheses are that the intervention will have incremental cost-effectiveness ratios consistent with current standards of healthcare value in the United States.
Measured: 4 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 NYU Langone HealthThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Scott E Sherman, MD, MPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363245
- Sponsor's protocol ID
- CHART NYU
- Other IDs
- 1U01HL10522901, 3U01HL105229-03S2
- Status last verified
- Jul 2015
- First submitted
- 31 Jan 2011
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- 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 31687769Cody GR, Wang B, Link AR, Sherman SE. Characteristics of Urban Inpatient Smokers With and Without Chronic Pain: Foundations for Targeted Cessation Programs. Subst Use Misuse. 2019;54(7):1138-1145. doi: 10.1080/10826084.2018.1563186. Epub 2019 Feb 1.
PubMed 30706753Sherman SE, Link AR, Rogers ES, Krebs P, Ladapo JA, Shelley DR, Fang Y, Wang B, Grossman E. Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial. Am J Prev Med. 2016 Oct;51(4):566-77. doi: 10.1016/j.amepre.2016.06.023.
PubMed 27647057Duffy 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 26336372Grossman E, Shelley D, Braithwaite RS, Lobach I, Goffin A, Rogers E, Sherman S. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:126. doi: 10.1186/1745-6215-13-126.
PubMed 22852878
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
- ClinicalTrials.gov ID
- NCT01363245
- Acronym / sponsor ID
- CHART NYU
- Conditions
- Smoking Cessation
- Keywords
- cost effectiveness, behavioral health counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,618 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Jun 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.
The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.
Detailed description
Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy.
The primary aims are:
Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral).
Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective.
The secondary aims are:
Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital phone counseling | Experimental | Behavioral: Telephone Counselingmultisession telephone counseling by hospital/study's smoking cessation staff |
| Fax-to-quit | Active comparator | Behavioral: Fax-to-quitFaxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- smoked tobacco during the prior 30 days
- have an active phone number
- provide consent in English, Spanish or Mandarin
Key exclusion criteria (3 listed)
- Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting)
- are pregnant or breastfeeding
- are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).
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 |
|---|---|---|
| Telephone CounselingTelephone counseling: 7 calls over 6 weeks | Behavioural | Hospital phone counseling |
| Fax-to-quitreferral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks | Behavioural | Fax-to-quit |
Primary outcome
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study
Time frame: 4 yrs
To compare the effectiveness of a phone counseling intervention (proactive multisession telephone counseling by in-hospital staff) versus control intervention ('fax-to-quit' Quitline referral)
5 secondary outcomes
Comparison of cessation outcomes by sociodemographic subgroups
Time frame: 4yrs
Comparison of cessation rates at 6 and 12 months post-discharge
Time frame: 4yrs
Comparison of biochemically-verified smoking cessation
Time frame: 4 years
Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not
Time frame: 2 years
Cost Effectiveness comparison of two smoking cessation interventions.
Time frame: 4 yrs
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 2 Jul 2015.
- 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 30706753Cody GR, Wang B, Link AR, Sherman SE. Characteristics of Urban Inpatient Smokers With and Without Chronic Pain: Foundations for Targeted Cessation Programs. Subst Use Misuse. 2019;54(7):1138-1145. doi: 10.1080/10826084.2018.1563186. Epub 2019 Feb 1.
- Derived from this study: PubMed 27647057Sherman SE, Link AR, Rogers ES, Krebs P, Ladapo JA, Shelley DR, Fang Y, Wang B, Grossman E. Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial. Am J Prev Med. 2016 Oct;51(4):566-77. doi: 10.1016/j.amepre.2016.06.023.
- 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 22852878Grossman E, Shelley D, Braithwaite RS, Lobach I, Goffin A, Rogers E, Sherman S. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:126. doi: 10.1186/1745-6215-13-126.
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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.
Scott E Sherman, MD, MPH principal investigator
NYU School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Counseling and Fax-to-quit in people with Smoking Cessation, run by NYU Langone Health at 2 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 4 inclusion and 3 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 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (time frame: 4 yrs). 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 NCT01363245, which also lists 5 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 2 Jul 2015.