Can we introduce evidence based prescribing of complementary drug therapies into primary care? A randomised controlled trial.

ISRCTN ISRCTN19338940
DOI https://doi.org/10.1186/ISRCTN19338940
Secondary identifying numbers N/A
Submission date
01/11/2005
Registration date
20/12/2005
Last edited
19/07/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
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

Contact information

Prof Maria Paola Dey
Scientific

Department of Public Health
Bury Primary Care Trust
21 Silver Street
Bury
BL9 0EN
United Kingdom

Email MPDey@uclan.ac.uk

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesTo determine the impact of dissemination to GPs of a recommendation about glucosamine sulphate for knee osteoarthritis, endorsed by Bury PCT Medicines Subgroup on:
1. The frequency with which glucosamine sulphate is prescribed in primary care
2. The appropriateness of prescribing
3. The frequency with which non-steroidal anti-inflammatory drug (NSAID)/COX2 inhibitors are prescribed
4. The frequency of serious NSAID associated gastrointestinal effects
Ethics approval(s)Approved by the Oldham research ethics committee (ref: 03/OL/105) Last amendment 13/06/2004.
Health condition(s) or problem(s) studiedOsteoarthritis
InterventionDissemination of a recommendation for the prescribing of glucosamine for knee osteoarthritis endosed by the Bury PCT Medicines Management Subgroup and accompanied by a letter of support signed by the Director of Public Health, Bury PCT.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Glucosamine sulphate
Primary outcome measureChange in the mean number of prescriptions for glucosamine sulphate 500 mg per general practitioner over study period.
Secondary outcome measures1. Change in cost to the NHS of prescriptions for glucosamine per general practitioner over study period
2. Proportion of GP prescribing glucosamine sulphate 500 mg during study period
3. If sufficient change in prescribing observed, number of admissions for gastrointestinal bleeding
4. Change in mean number of prescriptions of NSAID and COX2
Overall study start date26/06/2004
Completion date01/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants55 general practitioners
Key inclusion criteriaGeneral practitioners in Bury PCT
Key exclusion criteriaGeneral practitioners on the local medicines management subgroup and the other GPs in their practices
Date of first enrolment26/06/2004
Date of final enrolment01/07/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Public Health
Bury
BL9 0EN
United Kingdom

Sponsor information

Bury Primary Care Trust (UK)
Hospital/treatment centre

21 Silver Street
Bury
BL9 0EN
England
United Kingdom

Website http://www.burypct.nhs.uk

Funders

Funder type

Government

Bury Primary Care Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan