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
Protocol serial number	N/A
Sponsor	Bury Primary Care Trust (UK)
Funder	Bury Primary Care Trust (UK)

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

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To 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) studied	Osteoarthritis
Intervention	Dissemination 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 type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Glucosamine sulphate
Primary outcome measure(s)	Change in the mean number of prescriptions for glucosamine sulphate 500 mg per general practitioner over study period.
Key secondary outcome measure(s)	1. 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
Completion date	01/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	55
Key inclusion criteria	General practitioners in Bury PCT
Key exclusion criteria	General practitioners on the local medicines management subgroup and the other GPs in their practices
Date of first enrolment	26/06/2004
Date of final enrolment	01/07/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Public Health

Bury
BL9 0EN
United Kingdom

Results and Publications

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