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