Physician's Practice PatternsEPIPPNCT02512198
Electronic Prescription Data to Improve Primary Care Prescribing
A study testing Prescription Data Feedback to GP Practices in people with Physician's Practice Patterns, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physician's Practice Patterns
- What is being tested?
- Prescription Data Feedback to GP Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GP practices in the participating Health Board area (NHS Greater Glasgow and Clyde)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Physician's Practice Patterns
- Being tested
- Prescription Data Feedback to GP Practices
- Keywords
- Professional Practice, General Practitioners, Inappropriate Prescribing, Persuasive Communication, Information Theory, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription Data Feedback to GP PracticesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilators | Experimental | 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). Receives: Behavioral: Prescription Data Feedback to GP Practices |
| Antibiotics | Experimental | 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). Receives: Behavioral: Prescription Data Feedback to GP Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people identified by the measures of high risk or low quality prescribing
Measured: 12 months
Secondary outcomes (1)
Cost-effectiveness of feedback
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician's Practice PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
- Investigators
- Sean PD MacBride-Stewart, MSc, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512198
- Sponsor's protocol ID
- UREC15066
- Acronym
- EPIPP
- Status last verified
- May 2021
- First submitted
- 23 Jul 2015
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Prescription Data to Improve Primary Care Prescribing
- ClinicalTrials.gov ID
- NCT02512198
- Acronym / sponsor ID
- EPIPP / UREC15066
- Conditions
- Physician's Practice Patterns
- Keywords
- Professional Practice, General Practitioners, Inappropriate Prescribing, Persuasive Communication, Information Theory, Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchodilators | Experimental | Behavioral: Prescription Data Feedback to GP PracticesPrescription 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). |
| Antibiotics | Experimental | Behavioral: Prescription Data Feedback to GP PracticesPrescription 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GP practices in the participating Health Board area (NHS Greater Glasgow and Clyde)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription Data Feedback to GP PracticesGP 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. | Behavioural | Antibiotics, Bronchodilators |
Primary outcome
Number of people identified by the measures of high risk or low quality prescribing
Time frame: 12 months
1 secondary outcome
Cost-effectiveness of feedback
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean PD MacBride-Stewart, MSc principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription Data Feedback to GP Practices in people with Physician's Practice Patterns, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people identified by the measures of high risk or low quality prescribing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.