Condition category
Mental and Behavioural Disorders
Date applied
19/02/2010
Date assigned
14/04/2010
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.helsinki.fi/hammas/tupakka

Contact information

Type

Scientific

Primary contact

Prof Heikki Murtomaa

ORCID ID

Contact details

POB 41
Helsinki
00014
Finland
heikki.murtomaa@helsinki.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Enhancing Oral Health Professionals' competencies in Tobacco Use Prevention and Cessation: A randomised controlled community-based trial

Acronym

OH-No-TOBACCO

Study hypothesis

The main hypothesis is that an educational training intervention that includes information on
1. tobacco use and oral health
2. tobacco dependence as a chronic condition
3. treatment options for tobacco dependence
4. the practice guideline "Treating Tobacco Use and Dependence"
will reduce the barriers and facilitate the delivery of tobacco dependence counselling and treatment by oral health professionals to their patients if the administration of health centres enables and motivates them to do so.

Ethics approval

1. Ethical Committee of Tampere Hospital District approved on the 7th of November 2009 (ref: R08108)
2. Ethical Committee of Vaasa Hospital District approved on the 14th of October 2009 (ref: 9/2008)

Study design

Randomised controlled community-based trial

Primary study design

Interventional

Secondary study design

Other

Trial setting

Other

Trial type

Prevention

Patient information sheet

Patient information materials can be found at http://www.helsinki.fi/hammas/tupakka (in Finnish, to be translated to English)

Condition

Smoking

Intervention

We compare the effects of two interventions on the implementation of the Clinical Practice Guideline "Treating Tobacco Use and Dependence" among dental practitioners. Dental clinics participating in this study will be primary care dental centres in the cities of Vaasa and Tampere, Finland. All dental clinics in Vaasa (about 12 clinics) and Tampere (about 34 clinics) health centres will participate with no exceptions. Dental clinics will be randomly assigned to one of three groups, so that the three groups have an equivalent number of clinics assigned. Before intervention, principles of documenting patientsÂ’ tobacco use into medical records are instructed to all clinics. The intervention components to be tested are as follows:
Group A: Controls (Routine Care)
Group B: Educational Intervention
Group C: Educational Intervention + Monetary incentives

The educational intervention was exactly the same for both groups B and C. The total duration of the educational intervention was seven hours administered during one day from 8:00 a.m. to 3:00 p.m. Five hours of intensive training, included lectures, Q&A sessions, multi-media demonstrations, and a role play session with standard patient cases where the students were working in smaller groups. During the coffee and lunch breaks the students had an opportunity to study a selection of self-help materials and nicotine replacement therapy options in treatment of tobacco dependence. Study material included a binder with hand-outs of each teaching session as well as of the patient cases and a wide range of internet based sources of relevant information with the links for each site provided. All these materials were entered also to the project web site to be accessible in electronic format later on for participants of the educational intervention (username and password given).
Teaching modules included
1. Epidemiology of tobacco use and its health consequences
2. Role of oral health professionals in prevention and cessation of tobacco use
3. Tobacco dependence
4. Pharmacological treatment of tobacco dependence
5. Non-pharmacological treatment of tobacco dependence
6. How to implement the 6Ks in oral health practice (Finnish modification of the 5 As Clinical Practice Guideline "Treating Tobacco Use and Dependence")
7. Youth and tobacco
8. Resources and self help materials
9. Standard patient cases session. It took place in three groups (being mentored by one of the teachers plus one assistant). There were six standard patient cases (2 female/ 4 male; 2 adolescent/4 adult; 4 cigarette smokers/2smokeless tobacco users) played out by professional actors and/or students. There was a written protocol and time schedule to follow in each group to ensure that each participant of the educational intervention had an opportunity to practice tobacco dependence counseling at least once and that all patient cases could be practiced in every group. After the small group sessions, all the participants were invited back to the lecture setting where the teachers gave feed-back for possible solutions for each patient case treatment and counseling.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Provider behaviour and performance assessment by questionnaires and dental record audit, assessed at 1 and 6 months after the educational intervention.

Secondary outcome measures

Patient tobacco use behaviour assessment by patient questionnaires and dental record audit, assessed at baseline and 6 months.

Overall trial start date

16/11/2009

Overall trial end date

16/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Dentists and dental hygienists are included if the following criteria are met:
1.1. Dental providers working in one of the primary care dental clinics in the cities of Tampere or Vaasa
1.2. Provide written informed consent
2. Patients attending enrolled practices are included if the following criteria are met:
2.1. They visit one of the dental clinics in the cities of Tampere or Vaasa during four weeks starting from November 16th, 2009
2.2. Provide written informed consent
2.3. Are 12 to 40 years of age
2.4. Are able to read and understand spoken Finnish or Swedish to a level where they can read the study information sheet, complete the consent form, and respond to questionnaire

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Dental providers 150 and 5000 patients

Participant exclusion criteria

Dentists and dental hygienists will be excluded if the following criteria are met:
1. Dental providers working in the emergency care or special treatment clinics in the city of Tampere

Recruitment start date

16/11/2009

Recruitment end date

16/05/2010

Locations

Countries of recruitment

Finland

Trial participating centre

POB 41
Helsinki
00014
Finland

Sponsor information

Organisation

Academy of Finland (Finland)

Sponsor details

Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland
kirjaamo@akatemia.fi

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Academy of Finland (Finland) (grant ref: 130966)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes