ISRCTN - ISRCTN09576376: Dental care REsistance prevention and Antibiotic prescribing Modification the DREAM trial

Plain English Summary

Background and study aims
Although primary care dentists are generally aware of problems related to antibiotic resistance, in German dental primary care antibiotics are prescribed too often. Qualitative open-ended interviews and group discussions with primary care dentists showed that there are multiple reasons. Uncertainty (e.g. related to recent changes concerning the prophylaxes of endocarditis), perceived prescription pressure of patients suffering from severe pain (especially during emergency services), and unawareness play a major role here. The DREAM trial will test an intervention that aims at optimizing the prescription of antibiotics in dental care.

Who can participate?
The DREAM trial will include more than 50 dentists of the German region of Mecklenburg-Western Pomerania. Participating dentists will provide data on the amount of patients they take care of as well as on the number of antibiotics prescribed. This information will be derived from dentists practice software systems. All together, information on more than 46,000 patients will be included and scientifically analyzed. In addition, microbiological analyses will be performed within a subgroup of patients suffering from oral infections. These analyses will give insights into the level and development of microbial resistance.

What does the study involve?
During three six-month periods of data collection, information on the number of patients and antibiotic prescriptions will be collected. After the first data collection period, dentists will be randomly allocated to the intervention or control group. Dentists of the intervention group will attend a training session that aims at optimizing antibiotic prescribing. Dentists of the control group will provide care as usual. The antibiotic prescription rates of the two groups will be compared. Further, patients included in the subgroup of microbiological analyses will be asked to provide oral swabs at three different points in time. During a telephone interview, these patients will also be asked to provide information on the duration of treatment, the use of medical services, re-consultation, pain, and adverse effects related to antibiotic treatment.

What are the possible benefits and risks of participation?
Patients of the intervention group might benefit from their doctors increased awareness towards unnecessary antibiotic prescriptions. In the best case, patients benefit from more appropriate antibiotic prescribing. It is unlikely that the trial will harm patients.

Where is the study run from?
Institute of General Practice, the Clinic for Tooth Conservation and Periodontology, and the Department of Medical Microbiology, Virology and Hygiene, all located at the Rostock University Medical Center, Germany. The three institutions form one study centre.

When is the study starting and how long is it expected to run for?
The recruitment of dentists started in September 2012. Data collection started in January 2013 and will be finished by December 2014. The project is expected to run until March 2015.

Who is funding the study?
Funding is provided by the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG).

Who is the main contact?
Dr. Christin Löffler
christin.loeffler@med.uni-rostock.de

Trial website

http://allgemeinmedizin.med.uni-rostock.de/index.php?id=119

Contact information

Type

Scientific

Primary contact

Dr Christin Löffler

ORCID ID

Contact details

Universitätsmedizin Rostock
POB 100888
Rostock
18055
Germany
+49 (0)381 494 2485
christin.loeffler@med.uni-rostock.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Dental care REsistance prevention and Antibiotic prescribing Modification A cluster-randomised controlled trial in German dental primary care

Acronym

DREAM

Study hypothesis

The DREAM trial will test the effectiveness of a multifaceted educational intervention aiming at the reduction of inappropriate antibiotic prescribing in dental primary care. Care as usual serves as control.

Ethics approval

The ethics protocol was approved by the ethics committee of the University Medical Center Rostock (Ethikkommission an der Medizinischen Fakultät der Universität Rostock) on 18th December 2012. The reference number is A 2012-0147.

Study design

Two-arm single-centered cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Patient information can be found at http://allgemeinmedizin.med.uni-rostock.de/fileadmin/user_upload/DREAM_Infoblatt_Patienten_ohne_Unterschrift.pdf

Condition

Antibiotic prescribing in dental primary care

Intervention

The intervention involves elements of local consensus formation, antibiotic prescription feedback, and communication training. Training of the intervention group will be organized within small group sessions.

Control: Care as usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Dentists overall antibiotic prescription rate. Data is collected over a six-month baseline period (T0), at T1 (month 10 to 15), and T2 (month 19 to 24)

Secondary outcome measures

Secondary outcomes for the subgroup:
1. Severity of illness
2. Pain (VAS)
3. Duration of treatment
4. Re-consultation rate
5. Use of medical services
6. Adverse effects related to antibiotic treatment

Overall trial start date

01/09/2012

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary care dentists and their male and female patient population of all ages in Mecklenburg-Western Pomerania (Germany).
2. Patients aged 18 years or older seen by their dentists for an odontogenic infection or abscess, and who have not been treated for such a condition in the previous six months, are eligible for being recruited into the subgroup (swabs).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46.000 patients in 56 dental practices

Participant exclusion criteria

To investigate antibiotic prescribing the DREAM trial includes the entire patient population of participating dental practices.

Exclusion criteria for patients in the subgroup include:
1. Younger than 18 years
2. Not being able to give informed consent (e.g. in case of dementia)
3. Consulting the dentist during the emergency service
4. Suffering from immunosuppression or malignoma
5. Having a disease-related life expectancy of less than 12 months

Recruitment start date

01/09/2012

Recruitment end date

31/03/2015

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsmedizin Rostock
Rostock
18055
Germany

Sponsor information

Organisation

Medical University of Rostock (Universitätsmedizin Rostock) (Germany)

Sponsor details

c/o Prof Attila Altiner
POB 100888
Rostock
18055
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.med.uni-rostock.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data