Prevention of nicotine-associated morbidity by smoking cessation counselling in trauma patients in an emergency department

ISRCTN ISRCTN41527831
DOI https://doi.org/10.1186/ISRCTN41527831
Secondary identifying numbers N/A
Submission date
11/08/2006
Registration date
29/01/2007
Last edited
05/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Bruno Neuner
Scientific

Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany

Phone +49 (0)30 450 551001
Email anaesth@charite.de

Study information

Study designRandomised controlled trial (TED study) and postal survey (10-years follow-up)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePrevention of nicotine-associated morbidity by smoking cessation counselling in trauma patients in an emergency department
Study acronymTED study (Tobacco control in an urban Emergency Department)
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedSmoking addiction
InterventionParticipants 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 typeOther
Primary outcome measureSignificant rates of abstainers in those smokers who actively try to quit smoking
Secondary outcome measuresReduction in the number of cigarettes in smokers ambivalent concerning their smoking
Overall study start date01/10/2005
Completion date30/06/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1044
Key inclusion criteria1. Patients in an emergency department
2. Aged over 18
Key exclusion criteria1. 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
Date of first enrolment01/10/2005
Date of final enrolment21/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité – Universitätsmedizin Berlin
Department of Anaesthesiology and Operative Intensive Care Medicine
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

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

Website https://anaesthesieintensivmedizin.charite.de/
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

Charity

Deutsche Krebshilfe Grant-No.: DKH-106730 (TED-study) and DKH-111507 (10-years follow-up)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Stiftung Deutsche Krebshilfe, German Cancer Aid
Location
Germany

Results and Publications

Intention to publish date31/10/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2009 Yes No

Editorial Notes

05/07/2017: Plain English summary, publication and dissemination plan added.

04/07/2017: The following changes were made to the trial record:
1. The trial record was updated to include the 10 years follow-up postal survey.
2. The overall trial end date was changed from 01/04/2007 to 30/06/2016.
3. The target number of participants was changed from 1000 to 1044.