Condition category
Mental and Behavioural Disorders
Date applied
11/08/2006
Date assigned
29/01/2007
Last edited
05/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

https://anaesthesieintensivmedizin.charite.de/

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

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

Results - basic reporting

Publication summary

2009 results in: http://ncbi.nlm.nih.gov/sites/pubmed/19528043

Publication citations

  1. 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.

Additional files

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.