Clinical trial NCT01602705: Effective Feedback to Improve Primary Care Prescribing Safety
Official title: Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Surgical and Medical Care: General Terms
Keywords: Feedback (NOT MESH)
Medication errors
Medication review
Inappropriate medication
Randomised controlled trial
Primary Health Care
Family Practice
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: University of Strathclyde
name: Information Services Division, NHS Scotland
First posted: 2012-05-21
Enrollment: 262
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of proportion of patients at risk of an adverse event from specified prescribing.
timeFrame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS National Services Scotland
Study officials:
affiliation: Professor of Primary Care
name: Bruce Guthrie
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 13;2(6):e002359. doi: 10.1136/bmjopen-2012-002359. Print 2012.
citation: Guthrie B, Kavanagh K, Robertson C, Barnett K, Treweek S, Petrie D, Ritchie L, Bennie M. Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial. BMJ. 2016 Aug 18;354:i4079. doi: 10.1136/bmj.i4079.
citation: Barnett KN, Bennie M, Treweek S, Robertson C, Petrie DJ, Ritchie LD, Guthrie B. Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705). Implement Sci. 2014 Oct 11;9:133. doi: 10.1186/s13012-014-0133-9.