Electronic Prescription Data to Improve Primary Care Prescribing (EPIPP)

May 20, 2021 updated by: University of Dundee
This is a randomised controlled study to evaluate the effect of providing prescribing feedback that includes individual patient data to General Practitioners (GP) in Scotland on high risk or low quality prescribing.

Study Overview

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

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glasgow, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sean PD MacBride-Stewart, MSc, University of Dundee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

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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