Condition category
Not Applicable
Date applied
17/06/2008
Date assigned
07/08/2008
Last edited
06/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan Clarkson

ORCID ID

Contact details

Dental Health Services Research Unit
Mackenzie Building
Ninewells Hospital
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Translation research in a dental setting - decontamination in dental primary care: a randomised controlled trial of two educational strategies

Acronym

Study hypothesis

In comparison to postgraduate education alone, does the provision of postgraduate education coupled with theory-based, individualised, practice support visits lead to an effective and cost-effective increase in the implementation of postal guidance on the cleaning of dental instruments in dental primary care?

Ethics approval

Advice was sought from The Scotland A Research Ethics Committee. The opinion was that this study is service development and does not require to be reviewed by an NHS ethics committee.

Study design

Two-arm multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Decontamination in dental primary care

Intervention

The trial will compare the effectiveness and cost-effectiveness of 'tailored enabling' (theory-based, individualised, practice support visits) in addition to standard education to support the implementation into practice of Scottish Dental Clinical Effectiveness Programme (SDCEP) guidance for the cleaning of dental instruments.

Control arm:
Practices in the control arm will experience current practice, i.e., at least one member of the practice team will attend an NHS Education for Scotland (NES) section 63 decontamination course on the cleaning of dental instruments in general dental practice. Attendance at these courses is open to all members of the dental team and the course attendee will be nominated by the practice. The NES section 63 decontamination course employs a traditional didactic methodology and standardised content. The aim of this course is to increase awareness and knowledge of best decontamination practice.

Intervention arm:
Practices in the intervention arm will experience current practice (as per the control arm) followed up by 'tailored enabling'. 'Tailored enabling' comprises theory based, individualised, practice support visits delivered by the NES Infection Control Dental Support team (ICDS) using techniques based on psychological evidence and theories to help change their current practice, if required, to meet with the decontamination guidance. These techniques include identifying barriers and facilitators, verbal persuasion, teaching skills, goal setting, creating action plans, self monitoring and providing social support. In every practice, the ICDS team will assist the practice team to generate a list of behaviours that deviate from the guidance, make action plans with each team (where, when, who and how they will enact these behaviours) and plans to monitor progress. Each practice will receive one 'tailored-enabling' visit that will last for around three hours by one of the six members of the ICDS team. The visits will take place over a period of twelve months. To ensure standardisation of delivery, training will be provided to the ICDS team before the trial commences.

The intervention is a 4-hour training course and both arms will be followed up at 3 and 6 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Practice compliance with 13 key decontamination behaviours identified from the SDCEP guidance in pre-trial elicitation studies, involving key stakeholders including decontamination experts, general dental practitioners and dental care professionals. Compliance with these behaviours will be measured by observed practice and self report. Primary outcomes will be measured at 0, 3 and 6 months.

Secondary outcome measures

1. Beliefs (attitudes, perceived behavioural control, motivation and self efficacy), measured at 0, 3 and 6 months
2. Knowledge, measured at 0, 3 and 6 months
3. Economic cost analysis, measured at 6 months

Overall trial start date

01/08/2008

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

General Dental Practices in Scotland with an NHS list number

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

400 dental practices

Participant exclusion criteria

General Dental Practices in Scotland with an NHS list number where in practice decontamination support visits have previously taken place.

Recruitment start date

01/08/2008

Recruitment end date

31/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital
Dundee
DD2 4BF
United Kingdom

Sponsor information

Organisation

National Education for Scotland (NES) (UK)

Sponsor details

Dundee Dental Education Centre
The Frankland Building
Small's Wynd
University of Dundee
Dundee
DD1 4HN
United Kingdom

Sponsor type

Government

Website

http://www.nes.scot.nhs.uk

Funders

Funder type

Government

Funder name

The Scottish Government - Office of the Chief Dental Officer (UK)

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

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/06/2016: No publications found, verifying study status with principal investigator.