Condition category
Respiratory
Date applied
16/03/2010
Date assigned
17/03/2010
Last edited
24/02/2015
Prospective/Retrospective
Prospectively 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 Martin Gulliford

ORCID ID

Contact details

Division of Health and Social Care Research
Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
-
martin.gulliford@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

086921; UKCRN ID: 7412

Study information

Scientific title

Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into reducing antibiotic prescribing in respiratory illness

Acronym

Study hypothesis

To test the effectiveness of an electronic record-based intervention at achieving a reduction in antibiotic prescribing at consultations for respiratory illness between the ages of ages 18 and 59 years in intervention practices as compared with controls.

Ethics approval

London - Surrey Borders Research Ethics Committee, 21/12/2009, ref: 09/H0806/81

Study design

Interventional multicentre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

Respiratory tract infection

Intervention

Electronic prompts have been developed based on recommended clinical practice guidelines to be activated during consultations for respiratory tract infection (RTI) in the selected age range. During consultations with patients presenting with symptoms of RTI, primary care professionals will see the prompts which remind them of recommended standards of care in RTI. The prompts will also provide them with supporting information and links to evidence that supports the recommendations. The decision on whether to follow the treatment suggestions included in the prompt, or whether to prescribe antibiotics, will be at the discretion of the GP. The GP will also be able to terminate display of the prompt at any time. As indicated above, the prompts will only be activated during consultations by patients aged 18 to 59 years. There will be no intervention at control practices. The intervention phase will continue for 12 months at each practice.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of RTI consultations with antibiotics prescribed over 12 months

Secondary outcome measures

Measured at 12 months follow-up:
1. Age- and sex-specific rates of RTI consultation
2. Age- and sex-specific proportion of RTI consultations with antibiotics prescribed
3. Occurrence of RTI complications

Overall trial start date

01/04/2010

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 - 59 years, either sex
2. Registered at the practice for at least 3 years at the trial start date
3. First diagnosis of stroke recorded in the 24-month period before the trial start date

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 GP practices per group (100 practices in total)

Participant exclusion criteria

Younger than 18 years and over the age of 59 years

Recruitment start date

01/04/2010

Recruitment end date

31/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Health and Social Care Research
London
SE1 3QD
United Kingdom

Sponsor information

Organisation

The Wellcome Trust (UK)

Sponsor details

Gibbs Building
215 Euston Road
London
NW1 2BE
United Kingdom
-
contact@wellcome.ac.uk

Sponsor type

Charity

Website

http://www.wellcome.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21569237
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24919485
2014 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/25700144

Publication citations

  1. Protocol

    Gulliford MC, van Staa T, McDermott L, Dregan A, McCann G, Ashworth M, Charlton J, Grieve AP, Little P, Moore MV, Yardley L, , Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study)., Trials, 2011, 12, 115, doi: 10.1186/1745-6215-12-115.

  2. Results

    Gulliford MC, van Staa TP, McDermott L, McCann G, Charlton J, Dregan A, , Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)., Trials, 2014, 15, 220, doi: 10.1186/1745-6215-15-220.

  3. Results

    McDermott L, Yardley L, Little P, van Staa T, Dregan A, McCann G, Ashworth M, Gulliford M; eCRT research team, Process evaluation of a point-of-care cluster randomised trial using a computer-delivered intervention to reduce antibiotic prescribing in primary care, BMC Health Serv Res, 2014, 14, 1, 594, doi: 10.1186/s12913-014-0594-1.

Additional files

Editorial Notes