Clinical trial NCT02470923: In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy
Official title: In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Nicotine
Spirometry
Internal medicine
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2015-06-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention.

This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).

Detailed description: Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1):

Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.

Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).

Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).

All participants will be given a smoking cessation leaflet.

Eligibility criteria: Inclusion Criteria:

1. Admitted to Internal Medicine at Soroka University Medical Center.
2. Current cigarette smokers (≥ 10 cigarettes per day)
3. Provided written informed consent.

Exclusion Criteria:

1. Substance abuse (except for tobacco).
2. Handicapped or bed ridden patients.
3. Patients who don't speak Hebrew, English, Russian or Arabic.
4. Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.

Primary outcomes:
measure: Composite outcome: •Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling • Smoking cessation validated by CO exhale test<5 ppm
timeFrame: Within six months since discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
citation: Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: a systematic review. Arch Intern Med. 2008 Oct 13;168(18):1950-60. doi: 10.1001/archinte.168.18.1950.
citation: US Department of Health & Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. 2004. Accessed at www.surgeongeneral.gov/library/smokingconsequences/ on October 31, 2011.
citation: Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures--will hospitals do the right thing? N Engl J Med. 2012 Mar 29;366(13):1172-4. doi: 10.1056/NEJMp1115176. Epub 2012 Mar 14. No abstract available.
citation: Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. doi: 10.1002/14651858.CD000146.pub2.
citation: Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Singer DE, Pasternak RC. The use of nicotine-replacement therapy by hospitalized smokers. Am J Prev Med. 1999 Nov;17(4):255-9. doi: 10.1016/s0749-3797(99)00095-1.
citation: McRobbie H, Hajek P. Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionals. Addiction. 2001 Nov;96(11):1547-51. doi: 10.1046/j.1360-0443.2001.961115472.x.
citation: Thabane M; COPD Working Group. Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(4):1-50. Epub 2012 Mar 1.
citation: Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009 Apr;33(4):754-62. doi: 10.1183/09031936.00116308. Epub 2009 Jan 7.
citation: Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001007. doi: 10.1002/14651858.CD001007.pub2.
citation: Fiore MC, Jaén CR, Baker TB, et al: Clinical practice guideline: treating tobacco use and dependence: 2008 update. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service. Retrieved 2011-02-16.
citation: Israel health ministry report 2010, Accessed at: http://www.old.health.gov.il/download/pages/smoke10_290511.pdf