Clinical trial NCT01289275: Smoking Cessation in Hospitalized Smokers
Official title: Smoking Cessation in Hospitalized Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: tobacco cessation
smoking cessation
telephone
self-help
smoking abstinence
tobacco use disorder
hospital
cardiopulmonary diseases
disparity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-03
Enrollment: 1270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Hospital stay of less than 24 hours
* Inability to communicate orally
* Hypersensitivity to nicotine
* Pregnant
* Hospitalized for psychiatric treatment

Primary outcomes:
measure: Percentage of Participants With 30-day Abstinence
timeFrame: 6-months post enrollment
Secondary outcomes:
measure: Percentage of Smokers Making a 24-hour Quit Attempt
timeFrame: 6-months post enrollment
measure: Self-reported Re-hospitalization
timeFrame: 6-months post enrollment
measure: 30-day Abstinence
timeFrame: 2-months post enrollment
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Scripps Mercy - Chula Vista
state: California
city: Davis
country: United States
facility: Univeristy of California, Davis
state: California
city: La Jolla
country: United States
facility: UCSD - Thornton Hospital
state: California
city: San Diego
country: United States
facility: Scripps Mercy - San Diego Campus
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest
state: California
city: San Diego
country: United States
facility: University of California, San Diego: California Smokers' Helpline
state: California
Study officials:
affiliation: UCSD
name: Shu-Hong Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Cummins 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.