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Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01602705
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : October 7, 2014
Sponsor:
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  ICMJE May 17, 2012
First Posted Date  ICMJE May 21, 2012
Last Update Posted Date October 7, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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'.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Effective Feedback to Improve Primary Care Prescribing Safety
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Complications of Surgical and Medical Care: General Terms
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2012)
262
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602705
Other Study ID Numbers  ICMJE 2010PS06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bruce Guthrie, University of Dundee
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Dundee
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Chief Scientist Office of the Scottish Government
  • University of Strathclyde
  • Information Services Division, NHS Scotland
Investigators  ICMJE
Principal Investigator: Bruce Guthrie Professor of Primary Care
PRS Account University of Dundee
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP