Condition category
Infections and Infestations
Date applied
26/06/2006
Date assigned
22/08/2006
Last edited
22/05/2012
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

Prof Christopher Butler

ORCID ID

Contact details

Dept of General Practice
Cardiff University
3rd Floor Neuadd Merionnyd
Healh Park
Cardiff
CF14 4XN
United Kingdom
butlercc@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0500956

Study information

Scientific title

Acronym

STAR

Study hypothesis

To examine if exposing prescribers in general practices to the STAR Educational Programme results in fewer antibiotics being dispensed to the practice's patients.

Ethics approval

Not provided at time of registration

Study design

Cluster-randomised trial with randomisation and analysis at the level of general practice/general practitioner.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infections

Intervention

Clinicians in practices randomised to the experimential condition will be exposed to the STAR Educational Program. This involves unique use of practices' own prescribing and resistance data and novel consulting strategies. Both the 'why' and 'how' of change will be addressed. Training methods will include: seminars, software supported, self-directed learning, and reflecting on video and actual consultations.

Control practices will be offered the intervention after the initial one year follow-up of the experimental practices is complete.

Intervention type

Drug

Phase

Not Specified

Drug names

Oral Antibiotics

Primary outcome measures

Change in the total number of dispensed oral antibiotics (with examination of trend by quarter) per 1000 registered patients, for the year subsequent to the practice being exposed to the STAR programme, compared to the previous year, using PARC data.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2006

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

There are no inclusion or exclusion criteria, other than that we aim for two thirds of prescribers in each practice must agree to take part in the study. Practices will be approached at random and randomised in a way that balances for practice size and prior antibiotic prescribing.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Up to 60 practices (approximately 140-180 clinicians)

Participant exclusion criteria

N/A

Recruitment start date

01/06/2006

Recruitment end date

30/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of General Practice
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Heath Park
Cardiff
CF14 4XN
United Kingdom
davieskp2@cf.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC)(ref. no: G0500956) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20459655
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22302780

Publication citations

  1. Results

    Bekkers MJ, Simpson SA, Dunstan F, Hood K, Hare M, Evans J, Butler CC, , Enhancing the quality of antibiotic prescribing in primary care: qualitative evaluation of a blended learning intervention., BMC Fam Pract, 2010, 11, 34, doi: 10.1186/1471-2296-11-34.

  2. Results

    Butler CC, Simpson SA, Dunstan F, Rollnick S, Cohen D, Gillespie D, Evans MR, Alam MF, Bekkers MJ, Evans J, Moore L, Howe R, Hayes J, Hare M, Hood K, Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care: practice based randomised controlled trial., BMJ, 2012, 344, d8173.

Additional files

Editorial Notes