Effective Feedback to Improve Primary Care Prescribing Safety

NCT01602705 | Completed

• 1 other identifier: 2010PS06
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To assess the cost-effectiveness of the intervention

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Usual care

PLACEBO COMPARATOR

Other: Usual care

Usual care + feedback of practice performance

ACTIVE COMPARATOR

Other: Feedback of Performance

Usual care + feedback + health psychology intervention

ACTIVE COMPARATOR

Other: Feedback of Performance + Health Psychology Informed Intervention

Interventions

Usual care OTHER

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

Usual care

Feedback of Performance OTHER

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

Usual care + feedback of practice performance

Feedback of Performance + Health Psychology Informed Intervention OTHER

Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback

Usual care + feedback + health psychology intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

NHS National Services Scotland

Edinburgh, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 23242239 RESULT

• 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.

  PMID: 27540041 DERIVED

• 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.

  PMID: 25304255 DERIVED

Related Links

• Link to open access published protocol

Study Officials

• Bruce Guthrie

  Professor of Primary Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Primary Care Medicine

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

GB (1)