Smoking Cessation in Hospitalized Smokers
2 other identifiers
interventional
1,270
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
November 29, 2017
CompletedFebruary 13, 2020
February 1, 2020
2.9 years
January 31, 2011
October 26, 2017
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6-months post enrollment
Secondary Outcomes (3)
Percentage of Smokers Making a 24-hour Quit Attempt
6-months post enrollment
Self-reported Re-hospitalization
6-months post enrollment
30-day Abstinence
2-months post enrollment
Study Arms (4)
Telephone Counseling
EXPERIMENTALUp to 5 proactive counseling sessions
Nicotine Patches
EXPERIMENTAL8 weeks of nicotine patches
Telephone Counseling + Patches
EXPERIMENTAL5 proactive sessions, 8 weeks patches
Brief hospital counseling
ACTIVE COMPARATORbrief in hospital counseling, no proactive sessions or patches
Interventions
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.
Up to 5 proactive counseling sessions from California Smokers' Helpline.
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hospital stay of less than 24 hours
- Inability to communicate orally
- Hypersensitivity to nicotine
- Pregnant
- Hospitalized for psychiatric treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Scripps Mercy - Chula Vista
Chula Vista, California, 91910, United States
Univeristy of California, Davis
Davis, California, 95616, United States
UCSD - Thornton Hospital
La Jolla, California, 92037, United States
Scripps Mercy - San Diego Campus
San Diego, California, 92103, United States
UCSD Medical Center - Hillcrest
San Diego, California, 92103, United States
University of California, San Diego: California Smokers' Helpline
San Diego, California, 92111, United States
Related Publications (3)
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.
PMID: 27647058DERIVEDDuffy 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.
PMID: 26336372DERIVEDCummins 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.
PMID: 22853197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Cummins, Ph.D.
- Organization
- UC San Diego, California Smokers' Helpline
Study Officials
- PRINCIPAL INVESTIGATOR
Shu-Hong Zhu, Ph.D.
UCSD
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 3, 2011
Study Start
August 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
February 13, 2020
Results First Posted
November 29, 2017
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share