- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393536
Study of Whether Educational Visits to Primary Care Professionals Improves the Quality of Care They Provide.
A Pragmatic Randomized Controlled Trial of Untargeted Educational Outreach Visiting Delivered by Pharmaceutical Advisers in Primary Care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background There is increasing evidence that clinical guidelines can lead to improvements in both the process and outcome of care[1]. They figure prominently within the UK, particularly since the inception of the Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Clinical Excellence (NICE). However, clinical guidelines are not self-implementing and there is a growing body of research that demonstrates the effectiveness of various implementation strategies[1]. This has suggested that while the commonly used strategy of the postal distribution of educational materials alone may change clinician's behaviour it is unlikely to lead to large changes in practice. Educational outreach visits, using a trained person to meet face-to-face with a health care professional to provide information, may improve practice, especially prescribing behaviour[1,2]. Previous studies of the effectiveness of outreach visiting in the UK NHS have used local pharmacists as the visitors[3,4]. All Primary Care Trusts (PCTs) in England employ Pharmaceutical Advisers who are pharmacists whose role is to provide, from a wide clinical and health service management perspective, advice on prescribing and related areas to general practitioners (GPs). Pharmaceutical Advisers routinely visit general practices and are seen as change agents; however, the formal delivery of educational outreach by them has not been evaluated.
In 1996, the then Newcastle and North Tyneside Health Authority established a Clinical Effectiveness Unit. The remit of the Unit was to provide support to local health care teams in primary and secondary care, with the aim of promoting clinical effectiveness and encouraging the use of best evidence in daily practice through systematic, evidence-based approaches to guideline implementation. The strategy adopted by the Clinical Effectiveness Unit was to concentrate on five clinical areas. These were selected by a multi-disciplinary steering group using explicit criteria (evidence of inappropriate variation in practice; a good evidence base for what should be done; the clinical area should be a source of significant morbidity or mortality; large cost implications in the management of the topic). Depression was one of the clinical areas chosen.
The aim of this study was, for the choice of antidepressants for the management of depression, to evaluate, within a pragmatic cluster randomized controlled trial, the effectiveness of outreach visiting by existing Pharmaceutical Advisers in addition to the postal distribution of educational materials.
Methods Within a pragmatic randomized controlled trial, involving all general practices in two PCTs, routine methods were used to distribute guidelines for the choice of antidepressants for the management of depression. Intervention practices were offered two visits (most accepted only one) by their PCT Pharmaceutical Adviser who had been trained in the techniques of outreach visiting. The intervention was evaluated using level three Prescribing Analysis and Cost (PACT) data for antidepressant drugs for the six months during which the intervention was delivered and the subsequent 12 months
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne and Wear
-
Newcastle-upon-Tyne, Tyne and Wear, United Kingdom, NE2 4AA
- Institute of Health and Society
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all general practices in Newcastle and North Tyneside, England
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Usage of antidepressant drugs by type
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Costs of antidepressant drugs by type
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin P Eccles, MD, University of Newcastle Upon-Tyne
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UEOVPAPHC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.