| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN18154381 |
| Date ISRCTN assigned | 21/09/2006 |
| Local reference number(s) | COM/2732/04 |
| Public title | A collaborative primary care-based approach to managing upper respiratory tract infections as a strategy to reduce antibiotic prescribing |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Upper Respiratory Tract Infections |
| Study hypothesis | Can a collaborative primary care-based approach betwen community pharmacists and general practitioners decrease antibiotic prescribing for Upper Respiratory Tract Infections (URTIs). |
| Design/methodology | Phase 1 is a cluster randomised control trial. Phase 2 is a qualitative approach including focus groups and semi-structured interviews. |
| Research ethics review | Ethical approval was granted 20th July 2005 by the Office for Research Ethics Committee Northern Ireland No 3. REC (reference number: 05/NIR03/154). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/03/2005 |
| Anticipated end date | 28/02/2007 |
| Status of trial | Completed |
| Target number of participants | General Practices: 30; Pharmacies: 90; Patients: 7,500 |
| Interventions | 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. |
| Primary outcome measure(s) | The rate of antibiotic prescribing for URTIs. |
| 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 |
| Sources of funding | Research and Development Office, National Institutes of Health Stroke Scale (NIHSS) Central Services Agency (ref: COM/2732/04) |
| Sponsor name | Queen's University Belfast (UK) |
| Sponsor details | Lanyon Building
University Road
Belfast
United Kingdom
BT9 7BL |
| Sponsor telephone | +44 (0)28 9097 5800 |
| Sponsor fax | +44 (0)28 9024 7794 |
| Sponsor email | g.mcaleavey@qub.ac.uk |
| Contact name | Prof James McElnay |
| Contact details | Queen's University Belfast
Medical Biology Centre
97 Lisburn Road
Belfast
United Kingdom
BT9 7BL |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18154381 |
| Date last extracted from ISRCTN register | 17/04/2008 |
