Condition category
Respiratory
Date applied
20/06/2006
Date assigned
21/09/2006
Last edited
06/02/2014
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 James McElnay

ORCID ID

Contact details

Queen's University Belfast
Medical Biology Centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

COM/2732/04

Study information

Scientific title

Acronym

Study hypothesis

Can a collaborative primary care-based approach betwen community pharmacists and general practitioners decrease antibiotic prescribing for Upper Respiratory Tract Infections (URTIs).

Ethics approval

Ethical approval was granted 20th July 2005 by the Office for Research Ethics Committee Northern Ireland No 3. REC (reference number: 05/NIR03/154).

Study design

Phase 1 is a cluster randomised control trial. Phase 2 is a qualitative approach including focus groups and semi-structured interviews.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Upper Respiratory Tract Infections

Intervention

Intervention community pharmacists will assess patients referred from General Practitioner (GP) practices using the Network Organisation Technology Research Center (CENTOR) algorithm to assist them in making an appropriate treatment choice with a non-prescriptive medicine.

Control pharmacists will provide usual care.

Intervention type

Other

Phase

Phase I/II

Drug names

Primary outcome measures

The rate of antibiotic prescribing for URTIs.

Secondary outcome measures

1. Comparison of treatment success rates of URTIs between Intervention and Control groups
2. Patient satisfaction with URTI management
3. Economic analysis of the cost of the new pharmacy service

Overall trial start date

01/03/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. General practices with between 3,000 to 8,000 and over 8,000 patients and complete computerised prescribing
2. Community pharmacists who dispense 80% of issued prescriptions
3. Patients:
a. aged over five years
b. who request an appointment or prescription for an URTI
c. who use one of the participating pharmacies
d. who do not have a history of chronic respiratory or cardiac disease
e. who have not previously consulted with a pharmacist about their current symptoms

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

General Practices: 30; Pharmacies: 90; Patients: 7,500

Participant exclusion criteria

1. General Practices with less than 2,500 patients and incomplete computerised prescribing
2. Community pharmacists who dispense less than 80% of issued prescriptions
3. Patients:
a. aged under 5 years
b. who do not use one of the participating pharmacies
c. who have a history of chronic respiratory or cardiac disease
d. who have previously consulted with a pharmacist about their current symptoms

Recruitment start date

01/03/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
Belfast
BT9 7BL
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

Lanyon Building
University Road
Belfast
BT9 7BL
United Kingdom
+44 (0)28 9097 5800
g.mcaleavey@qub.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Research and Development Office, National Institutes of Health Stroke Scale (NIHSS) Central Services Agency (ref: COM/2732/04)

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