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Electronic Prescription Data to Improve Primary Care Prescribing (EPIPP)

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ClinicalTrials.gov Identifier: NCT02512198
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Bruce Guthrie, University of Dundee

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physician's Practice Patterns Behavioral: Prescription Data Feedback to GP Practices Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Electronic Prescription Data to Improve Primary Care Prescribing
Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 1, 2017

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).

Behavioral: Prescription Data Feedback to GP Practices
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).

Behavioral: Prescription Data Feedback to GP Practices
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.




Primary Outcome Measures :
  1. Number of people identified by the measures of high risk or low quality prescribing [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512198


Locations
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United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G12 0XH
Sponsors and Collaborators
University of Dundee
NHS Greater Glasgow and Clyde
Investigators
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Principal Investigator: Sean PD MacBride-Stewart, MSc University of Dundee

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Responsible Party: Bruce Guthrie, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT02512198     History of Changes
Other Study ID Numbers: UREC15066
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Keywords provided by Bruce Guthrie, University of Dundee:
Professional Practice
General Practitioners
Inappropriate Prescribing
Persuasive Communication
Information Theory
Feedback
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Bronchodilator Agents
Anti-Infective Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents