Effective Feedback to Improve Primary Care Prescribing Safety

Complications of Surgical and Medical Care: General Terms Clinical Trial

— EFIPPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602705
• Other study ID #: 2010PS06
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: October 5, 2014
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial Summary

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 :

1. 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

2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite

3. To assess the cost-effectiveness of the intervention

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complications of Surgical and Medical Care: General Terms

Intervention

Other:
• Usual care
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
• Feedback of Performance
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
• Feedback of Performance + Health Psychology Informed Intervention
Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback

Locations

Country	Name	City	State
United Kingdom	NHS National Services Scotland	Edinburgh

Sponsors (4)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government, Information Services Division, NHS Scotland, University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Guthrie B, Treweek S, Petrie D, Barnett K, Ritchie LD, Robertson C, Bennie M. Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data. BMJ Open. 2012 Dec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Link to open access published protocol