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 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | Deutsche Krebshilfe Grant-No.: DKH-106730 (TED-study) and DKH-111507 (10-years follow-up) |
- 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
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
Scientific
Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany
| Phone | +49 (0)30 450 551001 |
|---|---|
| anaesth@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial (TED study) and postal survey (10-years follow-up) |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prevention of nicotine-associated morbidity by smoking cessation counselling in trauma patients in an emergency department |
| Study acronym | TED study (Tobacco control in an urban Emergency Department) |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Significant rates of abstainers in those smokers who actively try to quit smoking |
| Key secondary outcome measure(s) |
Reduction in the number of cigarettes in smokers ambivalent concerning their smoking |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1044 |
| Key inclusion criteria | 1. Patients in an emergency department 2. Aged over 18 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 21/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
