Condition category
Not Applicable
Date applied
21/06/2013
Date assigned
15/08/2013
Last edited
01/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In April 2008 (updated in August 2011), the Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance for drug prescribing within dental practices. It contains information to help support dentists when making decisions about the need to prescribe an antibiotic. Despite the introduction of this guidance, there is wide variation in dental drug prescribing in Scotland. Antibiotic prescribing by dentists accounts for 9% of total antibiotic prescriptions in dental practices in Scotland and is increasing every year. It is widely recognised that antibiotic resistance (germs becoming resistant to antibiotics) is a major threat to public health and patient safety. There is evidence to suggest that prescribing by dentists in Scotland is too high and as many as 40% of antibiotic prescriptions issued in dental practices may be inappropriate. This study will test a method that aims to improve compliance with the SDCEP guidance recommendations to reduce antibiotic prescription.

Who can participate?
General dental practices providing NHS dental treatment across the 14 Scottish Health Boards will be included in the study. All dentists in these practices listed as practicing in March 2013 will be included. Hospitals and community health centres will be excluded from the study.

What does the study involve?
NHS dental practices will be randomly allocated to one of three groups – 1. current practice, 2. graphical feedback on antibiotic prescribing and 3. graphical feedback on antibiotic prescribing combined with recommendations for antibiotic prescribing taken from the SDCEP Drug Prescribing for Dentistry guidance. To produce the graphical feedback, information from the Prescribing Information System for Scotland (PRISMS) will be combined with information from the Management Information and Dental Accounting System (MIDAS), which contains information on all courses of NHS dental treatment provided in Scotland. The initial feedback will contain prescribing activity taken from the most recently available 14 months of information (November 2011 to December 2012). Dentists will receive a further graphical report at 6 months and 50% of dentists will receive a third report at 9 months. The antibiotic prescribing rates of the two groups receiving feedback will be compared with each other and with the current practice group.

What are the possible benefits and risks of participating?
Dentists may increase awareness of their antibiotic prescribing patterns. Patients may benefit from more appropriate prescribing. There is low risk to both dentists and patients. No patient identifiable information will be used in the study. Dentists receiving feedback will not be given information about the prescribing levels of the other dentists in their practice and it will not be possible to identify any other dentists from the feedback given.

Where is the study run from?
TRiaDS Programme Office, Dundee Dental Education Centre (UK), NHS Education for Scotland (UK), Smalls Wynd, Dundee (UK), supported by the Health Services Research Unit, University of Aberdeen (UK).

When is the study starting and how long is it expected to run for?
May 2013 to April 2014

Who is funding the study?
NHS Education for Scotland (UK)

Who is the main contact?
Dr Paula Elouafkaoui
Paula.Elouafkaoui@nes.scot.nhs.uk

Trial website

http://www.sdpbrn.org.uk/index.aspx?o=3376

Contact information

Type

Scientific

Primary contact

Dr Paula Elouafkaoui

ORCID ID

Contact details

Dundee Dental Education Centre
Smalls Wynd
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 740917
paula.elouafkaoui@nes.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Translation Research in a Dental Setting (TRiaDS) evaluation of an audit and feedback intervention for reducing antibiotic prescribing behaviour in primary dental care in Scotland

Acronym

RAPiD

Study hypothesis

In comparison to current practice does the provision of individualised feedback on antibiotic prescribing, with or without a comparator, plus or minus a text-based intervention lead to a reduction in antibiotic prescribing in dental primary care? The text-based intervention reiterates the ‘active ingredients’ within the Scottish Dental Clinical Effectiveness Programme’s (SDCEP) Drug Prescribing for Dentistry guidance.

Ethics approval

In line with the Governance Arrangements for Research Ethics Committees (GAfREC) 2011, studies involving NHS staff no longer require ethical review. This was confirmed by the East of Scotland Research Ethics Service on 20/12/2011, ref: 11/GA/229.

Study design

12-month three-arm 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

Antibiotic prescribing in dental primary care

Intervention

All dentists within each practice allocated to an intervention group will receive a graphical representation of their antibiotic prescribing rate. This will be in one of four formats:
1. Feedback material that illustrates their monthly antibiotic prescribing rate per 100 treatment claims submitted to PSD for payment (henceforth referred to as ‘claims’) over the previous 14 month period
2. Feedback material that illustrates their monthly antibiotic prescribing rate per 100 claims along with the overall prescribing rate for their Health Board over the previous 14 month period.
3. Feedback material as described in 1, but supplemented with a text based intervention.
4. Feedback material as described in 2, but supplemented with a text based intervention.
The initial feedback report will contain retrospective prescribing activity taken from the most recently available 14 months of prescribing and treatment provision data (covering the period from November 2011 to December 2012). During the course of the study, dentists in 50% of the practices allocated to an intervention group will receive two reports (at 0 and 6 months); those in the other practices will receive three reports (at 0, 6 and 9 months).

Practices in the control group will experience current audit practice i.e. they will receive no audit and feedback information on their antibiotic prescribing behaviour.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Total number of antibiotic items (from Section 5.1 of the British National Formulary) dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014.

Secondary outcome measures

1. Total number of Amoxicillin 3g items dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014
2. Total number of ‘second-line’ antibiotic items (Clindamycin, Co-amoxiclav, Clarithromycin) dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014
3. Total defined daily doses of antibiotics (from Section 5.1 of the British National Formulary) dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014
4. Total defined daily doses of Amoxicillin 3g dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014
5. Total defined daily doses of ‘second-line’ antibiotics (Clindamycin, Co-amoxiclav, Clarithromycin) dispensed per 100 courses of treatment over the 12 months from May 2013 to April 2014
6. Uptake of a national audit on antibiotic prescribing

Overall trial start date

01/05/2013

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Practice inclusion criteria: NHS general dental practices in the 14 Scottish Health Boards.

Participant inclusion criteria: General Dental Practitioners (GDPs), from included practices, listed by the Practitioners Services Division (PSD) of NHS National Services Scotland as currently practicing in March 2013.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

795 dental practices (2566 dentists)

Participant exclusion criteria

Practice exclusion criteria:
1. Practices in mainland Health Boards with salaried dentists. (Salaried dentists are used as a proxy to identify community and emergency dental services. Predominantly due to geography, the majority of dental services in the Island Boards are provided by the NHS salaried service. For this reason, practices with salaried dentists in the Island Boards are not excluded).
2. Practices where no NHS courses of treatment was provided in more than 6 months out of the most recently available 12 months of treatment provision data (January to December 2012).

Participant exclusion criteria: GDPs who are not recorded in the PSD list of dentists.

Recruitment start date

01/05/2013

Recruitment end date

30/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dundee Dental Education Centre
Dundee
DD1 4HN
United Kingdom

Sponsor information

Organisation

NHS Education for Scotland (UK)

Sponsor details

Westport 102
West Port
Edinburgh
EH3 9DN
United Kingdom
-
TRiaDS@nes.scot.nhs.uk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

NHS Education for Scotland (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24758164
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27575599

Publication citations

  1. Protocol

    Prior M, Elouafkaoui P, Elders A, Young L, Duncan EM, Newlands R, Clarkson JE, Ramsay CR, , Evaluating an audit and feedback intervention for reducing antibiotic prescribing behaviour in general dental practice (the RAPiD trial): a partial factorial cluster randomised trial protocol., Implement Sci, 2014, 9, 50, doi: 10.1186/1748-5908-9-50.

  2. Results

    Elouafkaoui P, Young L, Newlands R, Duncan EM, Elders A, Clarkson JE, Ramsay CR; Translation Research in a Dental Setting (TRiaDS) Research Methodology Group, An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice: The RAPiD Cluster Randomised Controlled Trial, PLoS Med, 2016, 13, 8, e1002115, doi: 10.1371/journal.pmed.1002115.

Additional files

Editorial Notes

01/09/2016: Publication reference added.