A collaborative primary care-based approach to managing upper respiratory tract infections as a strategy to reduce antibiotic prescribing

ISRCTN	ISRCTN18154381
DOI	https://doi.org/10.1186/ISRCTN18154381
Protocol serial number	COM/2732/04
Sponsor	Queen's University Belfast (UK)
Funder	Research and Development Office, National Institutes of Health Stroke Scale (NIHSS) Central Services Agency (ref: COM/2732/04)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof James McElnay
Scientific

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

Primary study design	Interventional
Study design	Phase 1 is a cluster randomised control trial. Phase 2 is a qualitative approach including focus groups and semi-structured interviews.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Can a collaborative primary care-based approach betwen community pharmacists and general practitioners decrease antibiotic prescribing for Upper Respiratory Tract Infections (URTIs).
Ethics approval(s)	Ethical approval was granted 20th July 2005 by the Office for Research Ethics Committee Northern Ireland No 3. REC (reference number: 05/NIR03/154).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The rate of antibiotic prescribing for URTIs.
Key secondary outcome measure(s)	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
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	7500
Key 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
Key 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
Date of first enrolment	01/03/2005
Date of final enrolment	28/02/2007

Queen's University Belfast

Belfast
BT9 7BL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan