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 measure
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 (if study stopped)
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
NHS 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
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
Basic results (scientific)
Publication list
2010 protocol in https://doi.org/10.1186/1748-5908-5-57 (added 15/01/2020)