Smoking Cessation in Hospitalized Smokers

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation in Hospitalized Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289275
• Other study ID #: 1U01CA159533-01
• Secondary ID: 5U01CA159533
• Status: Completed
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1270
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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
Up to 5 proactive counseling sessions from California Smokers' Helpline.
• Brief Hospital Counseling
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Locations

Country	Name	City	State
United States	Scripps Mercy - Chula Vista	Chula Vista	California
United States	Univeristy of California, Davis	Davis	California
United States	UCSD - Thornton Hospital	La Jolla	California
United States	Scripps Mercy - San Diego Campus	San Diego	California
United States	UCSD Medical Center - Hillcrest	San Diego	California
United States	University of California, San Diego: California Smokers' Helpline	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Smokers Making a 24-hour Quit Attempt		6-months post enrollment
Secondary	Self-reported Re-hospitalization		6-months post enrollment
Secondary	30-day Abstinence	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.	2-months post enrollment