Smoking Cessation in Hospitalized Smokers
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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 |
- 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.
- 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.
- 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 ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 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 |
Inclusion Criteria:
- 18 years or older
- Smoke >=6 CPD
- English or Spanish speaking
- Valid phone number
- Valid address
- CA resident
- Gave consent to participate in study and evaluation
Exclusion Criteria:
- Hospital stay of less than 24 hours
- Terminal illness (prognosis less than 12 months)
- Inability to communicate orally
- Hypersensitivity to nicotine
- Pregnant
- Hospitalized for psychiatric treatment
Contacts and Locations| Contact: Sharon Cummins, Ph.D. | 858-300-1046 | scummins@ucsd.edu |
| Contact: Carrie Kirby, M.S. | 858-300-1054 | ckirby@ucsd.edu |
| 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 | |
| UCSD - Thornton Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Carrie Kirby, MS 858-300-1054 ckirby@ucsd.edu | |
| University of California, San Diego: California Smokers' Helpline | Recruiting |
| San Diego, California, United States, 92111 | |
| Contact: Dee Segui 858-300-1018 dsegui@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 | |
| Scripps Mercy - San Diego Campus | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Kendra Brandstein, MPH 619-862-6601 brandstein.kendra@scrippshealth.org | |
| 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: | June 27, 2012 |
| 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:
|
Smoking Habits Nicotine Nicotine polacrilex 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 Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013