- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512198
Electronic Prescription Data to Improve Primary Care Prescribing (EPIPP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study makes use of data held in the Prescription Information System (PIS), the national database available to national health service (NHS) health boards in Scotland, on all prescriptions dispensed by community pharmacists which include the unique patient identifier for Scotland (CHI).
The design is a two parallel arm cluster randomised trial with general practices as the unit of randomisation to whom the feedback intervention is directed, and outcomes measured at patient level. Both arms receive the same active interventions but focused on different topics, with each acting as control to the other.
The primary outcome in the asthma arm is a composite of measure of potentially high-risk asthma prescribing (multiple short acting beta-agonists or single agent long acting beta-agonists both in the absence of inhaled corticosteroid therapy).
The primary outcome in the urinary tract infection antibiotic arm is a measure of repeated use of single (likely long-term prevention) or multiple (repeated treatment courses) urinary tract infection antibiotics.
Within the feedback, alongside the patient-level analysis, there will be action-orientated messages to guide the GP practice.
GP practices will get the reports three times at six-monthly intervals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom, G12 0XH
- NHS Greater Glasgow and Clyde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- GP practices in the participating Health Board area (NHS Greater Glasgow and Clyde)
Exclusion Criteria:
- GP practices with registered list sizes <250 patients (all of these are unusual practices in various ways, for example serving the homeless or people with challenging behaviour).
- GP practices with <80% of prescriptions for inhaled bronchodilators and UTI antibiotics in the prescription database with a recorded patient identifier for each month from January 2014 to December 2014.
- GP practices which were created after 1 January 2015.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bronchodilators
Prescription Data Feedback to GP Practices - practices will be fed back data for people with presumed asthma who have either been dispensed more than 12 short-acting beta-agonist bronchodilators in the last 12 months who are not concurrently prescribed inhaled corticosteroids (poor asthma control with inadequate prevention) or been dispensed a long-acting beta-agonist bronchodilator as a single agent in the last 12 months who are not or are only infrequently concurrently prescribed inhaled corticosteroids (potentially harmful prescribing). To minimise inclusion of people with COPD, patient aged 35 years and older prescribed long-acting antimuscarinic bronchodilators will be excluded. Practices in the bronchodilator arm are controls for the antibiotic experimental arm (below). |
GP practices will be randomly assigned to receive reports on one of the two topics.
They will get these three times at six-monthly intervals.
Within the feedback, alongside the patient-level analysis, there will be action-orientated messages to guide the GP practice.
|
Experimental: Antibiotics
Prescription Data Feedback to GP Practices - number of women in the GP practice aged 12 years and older dispensed more than 6 courses of urinary tract infection (UTI) antibiotics in the last year. UTI antibiotics are defined as trimethoprim, nitrofurantoin, co-trimoxazole, quinolones and cefalexin. Practices in the antibiotic arm are controls for the bronchodilator experimental arm (above). |
GP practices will be randomly assigned to receive reports on one of the two topics.
They will get these three times at six-monthly intervals.
Within the feedback, alongside the patient-level analysis, there will be action-orientated messages to guide the GP practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of people identified by the measures of high risk or low quality prescribing
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness of feedback
Time Frame: 12 months
|
The economic evaluation will estimate costs and benefits using the cost perspective of the NHS, it will take account medicines cost, costs within the GP practice and use of other NHS services.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sean PD MacBride-Stewart, MSc, University of Dundee
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UREC15066
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.
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