Smoking Cessation in Hospitalized Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shu-Hong Zhu, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01289275
First received: January 31, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Nicotine Patches
Behavioral: Telephone Counseling
Behavioral: Brief Hospital Counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation in Hospitalized Smokers

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 30-day abstinence [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of smokers making a 24-hour quit attempt [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
  • Continuous abstinence rates for those who made quit attempts [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
  • Self-reported re-hospitalization [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
  • 30-day abstinence [ Time Frame: 2-months post enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Counseling Behavioral: Telephone Counseling
Telephone counseling is conducted in the appropriate language (Spanish and English) by veteran counselors at the California Smokers' Helpline. The counseling protocol is similar to that used by the Helpline in previous efficacy studies. Counseling is proactive so after the smoker calls in subsequent calls are made by the counselor, a process that reduces attrition. The counseling group will receive proactive sessions initiated by quitline staff within 2 days of discharge, and a total of 6 individualized telephone counseling session that extend to two months post discharge. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors will use a structured protocol so that there will be a record for each counseling call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
Behavioral: Brief Hospital Counseling
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Experimental: Nicotine Patches Drug: Nicotine Patches
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.
Behavioral: Brief Hospital Counseling
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Experimental: Telephone Counseling and Nicotine Patches Drug: Nicotine Patches
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.
Behavioral: Telephone Counseling
Telephone counseling is conducted in the appropriate language (Spanish and English) by veteran counselors at the California Smokers' Helpline. The counseling protocol is similar to that used by the Helpline in previous efficacy studies. Counseling is proactive so after the smoker calls in subsequent calls are made by the counselor, a process that reduces attrition. The counseling group will receive proactive sessions initiated by quitline staff within 2 days of discharge, and a total of 6 individualized telephone counseling session that extend to two months post discharge. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors will use a structured protocol so that there will be a record for each counseling call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
Behavioral: Brief Hospital Counseling
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Active Comparator: Brief hospital counseling Behavioral: Brief Hospital Counseling
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289275

Contacts
Contact: Sharon Cummins, Ph.D. 858-300-1046 scummins@ucsd.edu
Contact: Carrie Kirby, M.S. 858-300-1054 ckirby@ucsd.edu

Locations
United States, California
Scripps Mercy - Chula Vista Recruiting
Chula Vista, California, United States, 91910
Contact: Kendra Brandstein, MPH    619-862-6601    brandstein.kendra@scrippshealth.org   
Univeristy of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Elisa Tong, M.D.    916-734-7005    elisa.tong@ucdmc.ucdavis.edu   
UCSD - Thornton Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Carrie Kirby, MS    858-300-1054    ckirby@ucsd.edu   
Scripps Mercy - San Diego Campus Recruiting
San Diego, California, United States, 92103
Contact: Kendra Brandstein, MPH    619-862-6601    brandstein.kendra@scrippshealth.org   
University of California, San Diego: California Smokers' Helpline Recruiting
San Diego, California, United States, 92111
Contact: Dee Segui    858-300-1018    psegui@ucsd.edu   
Contact: Chris Anderson    858-300-1032    canderson@ucsd.edu   
UCSD Medical Center - Hillcrest Recruiting
San Diego, California, United States, 92103
Contact: Carrie Kirby, MS    858-300-1054    ckirby@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Shu-Hong Zhu, Ph.D. UCSD
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shu-Hong Zhu, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01289275     History of Changes
Other Study ID Numbers: 1U01CA 159533-01
Study First Received: January 31, 2011
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
tobacco cessation
smoking cessation
telephone
self-help
smoking abstinence
tobacco use disorder
hospital
cardiopulmonary diseases
disparity

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014