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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL10522901 | Other Grant/Funding Number | NHLBI | |
| 3U01HL105229-03S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital phone counseling | Experimental | multisession telephone counseling by hospital/study's smoking cessation staff |
|
| Fax-to-quit | Active Comparator | Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Counseling | Behavioral | Telephone counseling: 7 calls over 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of cessation outcomes by sociodemographic subgroups | To compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization | 4yrs |
| Comparison of cessation rates at 6 and 12 months post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Sherman, MD, MPH | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New York Harbor Healthcare System | New York | New York | 10010 | United States | ||
| Bellevue Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31687769 | Derived | 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. | |
| 30706753 | Derived | Cody 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. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Fax-to-quit |
| Behavioral |
referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks |
|
To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge |
| 4yrs |
| Comparison of biochemically-verified smoking cessation | To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge | 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. | 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. | 4 yrs |
| New York |
| New York |
| 10016 |
| United States |
| 27647057 | Derived | Sherman 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. |
| 26336372 | Derived | 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. |
| 22852878 | Derived | Grossman 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. |