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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Complications of Surgical and Medical Care: General Terms Other: Usual care Other: Feedback of Performance Other: Feedback of Performance + Health Psychology Informed Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data
Study Start Date : June 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Usual care 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
Active Comparator: Usual care + feedback of practice performance 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
Active Comparator: Usual care + feedback + health psychology intervention 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


Outcome Measures
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Primary Outcome Measures :
  1. 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'.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602705


Locations
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United Kingdom
NHS National Services Scotland
Edinburgh, United Kingdom
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
University of Strathclyde
Information Services Division, NHS Scotland
Investigators
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Principal Investigator: Bruce Guthrie Professor of Primary Care
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bruce Guthrie, Professor of Primary Care Medicine, University of Dundee
ClinicalTrials.gov Identifier: NCT01602705    
Other Study ID Numbers: 2010PS06
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Bruce Guthrie, University of Dundee:
Feedback (NOT MESH)
Medication errors
Medication review
Inappropriate medication
 Randomised controlled trial
Primary Health Care
Family Practice