Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS)

• ClinicalTrials.gov Identifier: NCT01602705
• Recruitment Status: Completed
• First Posted: May 21, 2012
• Last Update Posted: October 7, 2014
• Sponsor: University of Dundee
• Collaborators: Chief Scientist Office of the Scottish Government; University of Strathclyde; Information Services Division, NHS Scotland
• Information provided by (Responsible Party): Bruce Guthrie, University of Dundee

Tracking Information

• First Submitted Date: May 17, 2012
• First Posted Date: May 21, 2012
• Last Update Posted Date: October 7, 2014
• Study Start Date: June 2012
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2012)

Composite measure of proportion of patients at risk of an adverse event from specified prescribing. [ Time Frame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention ]

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'.

Original Primary Outcome Measures (submitted: May 17, 2012)

Composite measure of proportion of patients at risk of an adverse event from specified prescribing. [ Time Frame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention ]

The primary outcome is a composite of the six individual secondary outcome indicators, and 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'.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: May 17, 2012)

The six individual high risk prescribing measures [ Time Frame: Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention ]

1.Antipsychotic prescribed to pt aged 75+. 2.Oral non-steroidal anti-inflammatory drug (NSAID) prescribed to pt aged 65+ taking both a diuretic and an ACE inhibitor or Angiotensin Receptor Blocker. 3.Oral NSAID prescribed to pt aged 75+ not taking gastroprotective drug. 4.Oral NSAID prescribed to pt aged 65+ taking either aspirin or clopidogrel, and not taking gastroprotective drug. 5.Oral NSAID prescribed to a pt taking an oral anticoagulant and not taking gastroprotective drug. 6.Aspirin or clopidogrel prescribed to a pt taking an oral anticoagulant and not taking gastroprotective drug.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: 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
• Other: 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
• Other: 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

Study Arms

• Placebo Comparator: Usual care
  Intervention: Other: Usual care
• Active Comparator: Usual care + feedback of practice performance
  Intervention: Other: Feedback of Performance
• Active Comparator: Usual care + feedback + health psychology intervention
  Intervention: Other: Feedback of Performance + Health Psychology Informed Intervention

Publications *

• 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). pii: e002359. doi: 10.1136/bmjopen-2012-002359. Print 2012.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2012): 262
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01602705
• Other Study ID Numbers: 2010PS06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bruce Guthrie, University of Dundee
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Dundee
• Original Study Sponsor: Same as current

Collaborators

• Chief Scientist Office of the Scottish Government
• University of Strathclyde
• Information Services Division, NHS Scotland

Investigators

• Principal Investigator: Bruce Guthrie; Professor of Primary Care

• PRS Account: University of Dundee
• Verification Date: October 2014