Effective Feedback to Improve Primary Care Prescribing Safety

Study Overview
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Brief Summary
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We hypothesise that feedback and feedback + psychology informed intervention delivered to primary care medical practices will reduce high-risk prescribing to patients compared to a simple educational intervention alone. The specific objectives are : To test the effectiveness of the two EFIPPS feedback arms in reducing the specified primary outcome of a composite measure of high-risk antipsychotic, non-steroidal anti-inflammatory drug, and antiplatelet drug prescribing To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite To assess the cost-effectiveness of the intervention

Detailed Description
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High risk prescribing is the use of drugs which carry significant risk to patients. Such prescribing is not always inappropriate but does require regular review to ensure that the balance of risk and benefit in individuals is appropriate. High risk prescribing is common and varies widely between practices, and there is evidence that intensive interventions (for example, pharmacist led medication review) can reduce rates of high risk prescribing. The aim of this study is to test whether a simpler and therefore cheaper feedback intervention can reduce high risk prescribing. The study is a three arm cluster randomised trial with primary care medical practices as the unit of randomisation and outcomes measured at patient level using routinely held prescribing for individual patients. The trial will compare two forms of feedback of practice rates of high risk prescribing with usual care. Usual care matches existing NHS working practice. The first active arm will receive quarterly feedback. The second active arm will receive the same feedback plus a health psychology informed intervention designed to promote response to feedback embedded in the feedback.

Official Title
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Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data

Conditions
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Complications of Surgical and Medical Care: General Terms

Intervention / Treatment
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* Other: Usual care
* Other: Feedback of Performance
* Other: Feedback of Performance + Health Psychology Informed Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian Exclusion Criteria: Practices with <250 registered patients Practices with <93% of scripts in the new PIS data warehouse having a unique patient identifier (the Community Health Index [CHI] number) Practices which were formed after 1st January 2011 Practices which cease to exist during the trial Practices which merge during the trial, where the merging practices were originally in different arms of the trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual care<br> | Other: Usual care<br>* Practices in the usual care arm receive a one-off educational newsletter and support for searching for patients in their electronic health record in the form of downloadable searches<br>|
| Active Comparator: Usual care + feedback of practice performance<br> | Other: Feedback of Performance<br>* Usual care (educational newsletter and support for searching) plus quarterly feedback of practice rates of high risk prescribing compared to a benchmark of the upper quartile of all practices in the year before<br>|
| Active Comparator: Usual care + feedback + health psychology intervention<br> | Other: Feedback of Performance + Health Psychology Informed Intervention<br>* Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of proportion of patients at risk of an adverse event from specified prescribing. | The primary outcome is a composite of six high-risk prescribing measures relating to antipsychotic, non-steroidal anti-inflammatory and antiplatelet drug use. It is defined as the proportion of patients particularly at risk of an adverse event from the specified prescribing, who receives one or more high risk prescriptions. A composite is reasonable because each of the underlying indicators is based on evidence of harm and has been judged valid in one or more formal consensus studies, so the composite is a coherent measure of 'high-risk prescribing'. | Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feedback (NOT MESH), Medication errors, Medication review, Inappropriate medication, Randomised controlled trial, Primary Health Care, Family Practice