Plain English Summary
Background and study aims
Emergency departments (EDs) are suitable settings for screening and health promotion. A number of studies showed effective strategies for the prevention of the negative consequences of alcohol consumption. There is little evidence about the benefits of screening and prevention programs for tobacco use. Therefore, the aim of this study is to find out whether smokers in an emergency department benefit from a tobacco control program.
Who can participate?
Patients aged over 18 in an emergency department
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives a motivational interview on site and up to four booster telephone calls intended to motivate smoking patients to quit. They also receive an information leaflet and, if desired, nicotine patches and gum. The other group receives the information leaflet only. Smoking rates are compared between the two groups. As there is evidence from other settings that tobacco control interventions show positive effects not only in the short term (some weeks or months) but also in the long-term (several years), all participants receive a postal questionnaire 10 years later to assess the long-term effects of the intervention.
What are the possible benefits and risks of participating?
All participants undergo screening for tobacco use and receive the information leaflet. Those participants allocated to the tobacco control program also receive a motivational interview. Participants in the control group are offered this program at the end of the study. There are no risks reported in regard to tobacco control programs.
Where is the study run from?
Charité – Universitätsmedizin Berlin (Germany)
When is the study starting and how long is it expected to run for?
October 2005 to June 2016
Who is funding the study?
German Cancer Aid
Who is the main contact?
Dr Bruno Neuner
anaesth@charite.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bruno Neuner
ORCID ID
Contact details
Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany
+49 (0)30 450 551001
anaesth@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevention of nicotine-associated morbidity by smoking cessation counselling in trauma patients in an emergency department
Acronym
TED study (Tobacco control in an urban Emergency Department)
Study hypothesis
The aim of this study is to investigate whether a 20 to 30 minutes counselling in smokers followed by four 5 to 15 minutes booster session by telephone leads to a significant reduction in the number of cigarettes in smokers ambivalent concerning their smoking and a significant rate of abstaining in those smokers who actively try to quit smoking.
Ethics approval
1. Original study: Ethics Committee of the Charité Universitätsmedizin, Berlin, 19/11/2004, ref: EA1/23/2004
2. 10 years follow-up postal survey: Ethics Committee of the Charité Universitätsmedizin, Berlin, 08/09/2015, ref: EA1/238/15
Study design
Randomised controlled trial (TED study) and postal survey (10-years follow-up)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Smoking addiction
Intervention
Participants are randomised to receive either:
1. A 20 to 30 minutes counselling session followed by four 5 to 15 minutes booster session by telephone
2. Care as usual
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Significant rates of abstainers in those smokers who actively try to quit smoking
Secondary outcome measures
Reduction in the number of cigarettes in smokers ambivalent concerning their smoking
Overall trial start date
01/10/2005
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients in an emergency department
2. Aged over 18
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1044
Participant exclusion criteria
1. Under 18 years of age
2. Altered mental status that precluded consent
3. Medically unstable
4. In significant pain
5. Were intoxicated by alcohol or drugs
6. Were non-German speaking
Recruitment start date
01/10/2005
Recruitment end date
21/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Charité – Universitätsmedizin Berlin
Department of Anaesthesiology and Operative Intensive Care Medicine
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
c/o Dr Bruno Neuner and Prof. Claudia Spies
Department of Anaesthesiology and Operative Intensive Care Medicine
Campus Charité Mitte
Charité – Universitätsmedizin Berlin
Charitéplatz 1
Berlin
10117
Germany
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Deutsche Krebshilfe Grant-No.: DKH-106730 (TED-study) and DKH-111507 (10-years follow-up)
Alternative name(s)
German Cancer Aid
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Germany
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/10/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in: http://ncbi.nlm.nih.gov/sites/pubmed/19528043
Publication citations
-
Results
Neuner B, Weiss-Gerlach E, Miller P, Martus P, Hesse D, Spies C, Emergency department-initiated tobacco control: a randomised controlled trial in an inner city university hospital, Tob Control, 2009 , 18, 4, 283-293.